Olumiant
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 2 mg film-coated tablets 
Olumiant 4 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Olumiant 2 mg film-coated tablets 
Each film-coated tablet contains 2 mg baricitinib. 
 
Olumiant 4 mg film-coated tablets 
Each film-coated tablet contains 4 mg baricitinib. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet).  
 
Olumiant 2 mg film-coated tablets 
Light pink, 9.0 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other.  
 
Olumiant 4 mg film-coated tablets 
Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other. 
 
The tablets contain a recessed area on each side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult 
patients who have responded inadequately to, or who are intolerant to one or more disease-modifying 
anti-rheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate (see 
sections 4.4, 4.5 and 5.1 for available data on different combinations). 
 
4.2 Posology and method of administration 
 
Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid 
arthritis. 
 
Posology 
 
The recommended dose of Olumiant is 4 mg once daily. A dose of 2 mg once daily is appropriate for 
patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or 
recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved 
sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see 
section 5.1). 
 



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Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 
0.5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a 
haemoglobin value less than 8 g/dL. Treatment may be initiated once values have improved above 
these limits (see section 4.4). 
 
Renal impairment  
The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 
60 mL/min. Olumiant is not recommended for use in patients with creatinine clearance < 30 mL/min 
(see section 5.2). 
 
Hepatic impairment 
No dose adjustment is required in patients with mild or moderate hepatic impairment. Olumiant is not 
recommended for use in patients with severe hepatic impairment (see section 5.2). 
 
Co-administration with OAT3 inhibitors 
The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) 
inhibitors with a strong inhibition potential, such as probenecid (see section 4.5).  
 
Elderly 
Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg 
is appropriate. 
 
Paediatric population 
The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been 
established. No data are available. 
 
Method of administration  
 
Oral use. 
Olumiant is to be taken once daily with or without food and may be taken at any time of the day.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Pregnancy (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Infections 
 
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections 
compared to placebo (see section 4.8). In treatment naïve patients, combination with methotrexate 
resulted in increased frequency of infections compared to baricitinib monotherapy. The risks and 
benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in 
patients with active, chronic or recurrent infections (see section 4.2). If an infection develops, the 
patient should be monitored carefully and Olumiant therapy should be temporarily interrupted  if the 
patient is not responding to standard therapy. Olumiant treatment should not be resumed until the 
infection resolves.  
 
Tuberculosis 
Patients should be screened for tuberculosis (TB) before starting Olumiant therapy. Olumiant should 
not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of 
Olumiant in patients with previously untreated latent TB. 
 



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Haematological abnormalities 
 
Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count 
(ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in less than 1 % of patients in 
clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with 
an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine 
patient management (see section 4.2).  
 
The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis. Rare cases of 
lymphoproliferative disorders have been reported. 
 
Viral reactivation 
 
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), 
were reported in clinical studies (see section 4.8). Herpes zoster was reported more commonly in 
patients ≥ 65 years of age who had previously been treated with both biologic and conventional 
DMARDs. If a patient develops herpes zoster, Olumiant treatment should be temporarily interrupted 
until the episode resolves. 
 
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting 
therapy with Olumiant. Patients with evidence of active hepatitis B or C infection were excluded from 
clinical trials. Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus 
RNA, were allowed to participate. Patients with hepatitis B surface antibody and hepatitis B core 
antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be 
monitored for expression of hepatitis B virus (HBV) DNA. If HBV DNA is detected, a liver specialist 
should be consulted to determine if treatment interruption is warranted. 
 
Vaccination 
 
No data are available on the response to vaccination with live vaccines in patients receiving 
baricitinib. Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not 
recommended.  Prior to initiating Olumiant, it is recommended that all patients be brought up to date 
with all immunisations in agreement with current immunisation guidelines. 
 
Lipids 
 
Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib 
compared to placebo (see section 4.8). Elevations in LDL cholesterol decreased to pre-treatment levels 
in response to statin therapy. Lipid parameters should be assessed approximately 12 weeks following 
initiation of Olumiant therapy and thereafter patients should be managed according to international 
clinical guidelines for hyperlipidaemia. The effect of these lipid parameter elevations on 
cardiovascular morbidity and mortality has not been determined.  
 
Hepatic transaminase elevations 
 
Increases in alanine transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10 x upper 
limit of normal (ULN) were reported in less than 1 % of patients in clinical trials. In treatment-naïve 
patients, combination with methotrexate resulted in increased frequency of hepatic transaminase 
elevations compared with baricitinib monotherapy (see section 4.8). If increases in ALT or AST are 
observed during routine patient management and drug-induced liver injury is suspected, Olumiant 
should be temporarily interrupted until this diagnosis is excluded. 
 
Malignancy 
 
The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis. 
Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma. 



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The clinical data are insufficient to assess the potential incidence of malignancies following exposure 
to baricitinib. Long-term safety evaluations are ongoing. 
 
Venous Thromboembolism 
 
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in 
patients receiving baricitinib. Olumiant should be used with caution in patients with risk factors for 
DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and 
immobilisation. If clinical features of DVT/PE occur, Olumiant treatment should be discontinued and 
patients should be evaluated promptly, followed by appropriate treatment. 
 
Laboratory monitoring 
 
Table 1. Laboratory measures and monitoring guidance  
 

Laboratory Measure Action Monitoring Guidance 

Lipid parameters 
Patients should be managed according 
to international clinical guidelines for 
hyperlipidaemia 

12 weeks after initiation of treatment 
and thereafter according to 
international clinical guidelines for 
hyperlipidaemia 

Absolute Neutrophil 
Count (ANC) 

Treatment should be interrupted if ANC 
< 1 x 109 cells/L and may be restarted 
once ANC return above this value 

Before treatment initiation and 
thereafter according to routine patient 
management  

Absolute Lymphocyte 
Count (ALC) 

Treatment should be interrupted if ALC 
< 0.5 x 109 cells/L and may be restarted 
once ALC return above this value 

Haemoglobin (Hb) 
Treatment should be interrupted if Hb 
< 8 g/dL and may be restarted once Hb 
return above this value 

Hepatic transaminases 
Treatment should be temporarily 
interrupted if drug-induced liver injury 
is suspected 

 
Immunosuppressive medicinal products 
 
Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a 
risk of additive immunosuppression cannot be excluded. Data concerning use of baricitinib with potent 
immunosuppressive medicinal products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and 
caution should be exercised when using such combinations (see section 4.5). 
 
Hypersensitivity 
 
In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration 
have been reported. If any serious allergic or anaphylactic reaction occurs, baricitinib should be 
discontinued immediately.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Pharmacodynamic interactions 
 
Immunosuppressive medicinal products 
Combination with biologic DMARDs or other JAK inhibitors has not been studied. Use of baricitinib 
with potent immunosuppressive medicinal products such as azathioprine, tacrolimus, or ciclosporin 



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was limited in clinical studies of baricitinib, and a risk of additive immunosuppression cannot be 
excluded (see section 4.4). 
 
Potential for other medicinal products to affect the pharmacokinetics of baricitinib 
 
Transporters 
In vitro, baricitinib is a substrate for organic anionic transporter (OAT)3, P-glycoprotein (Pgp), breast 
cancer resistance protein (BCRP) and multidrug and toxic extrusion protein (MATE)2-K. In a clinical 
pharmacology study, dosing of probenecid (an OAT3 inhibitor with strong inhibition potential) 
resulted in approximately a 2-fold increase in AUC(0-∞) with no change in tmax or Cmax of baricitinib. 
Consequently, the recommended dose in patients taking OAT3 inhibitors with a strong inhibition 
potential, such as probenecid, is 2 mg once daily (see section 4.2). No clinical pharmacology study has 
been conducted with OAT3 inhibitors with less inhibition potential. The prodrug leflunomide rapidly 
converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in 
baricitinib exposure. Since dedicated interaction studies have not been conducted, caution should be 
used when leflunomide or teriflunomide are given concomitantly with baricitinib. Concomitant use of 
the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however 
their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant 
interaction is not expected. Coadministration of baricitinib with ciclosporin (Pgp/BCRP inhibitor) or 
methotrexate (substrate of several transporters including OATP1B1, OAT1, OAT3, BCRP, MRP2, 
MRP3, and MRP4) resulted in no clinically meaningful effects on baricitinib exposure.  
 
Cytochrome P450 enzymes 
In vitro, baricitinib is a cytochrome P450 enzyme (CYP)3A4 substrate although less than 10 % of the 
dose is metabolised via oxidation. In clinical pharmacology studies, coadministration of baricitinib 
with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of 
baricitinib. Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 
inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to 
baricitinib exposure. 
 
Gastric pH modifying agents 
Elevating gastric pH with omeprazole had no clinically significant effect on baricitinib exposure.  
 
Potential for baricitinib to affect the pharmacokinetics of other medicinal products 
 
Transporters 
In vitro, baricitinib is not an inhibitor of OAT1, OAT2, OAT3, organic cationic transporter  (OCT) 2, 
OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations. 
Baricitinib may be a clinically relevant inhibitor of OCT1, however there are currently no known 
selective OCT1 substrates for which clinically significant interactions might be predicted. In clinical 
pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was 
coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters). 
 
Cytochrome P450 enzymes 
In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates 
simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the 
PK of these medicinal products. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can 
affect early embryonic development. There are no adequate data from the use of baricitinib in pregnant 
women. Studies in animals have shown reproductive toxicity (see section 5.3). Baricitinib was 



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teratogenic in rats and rabbits. Animal studies indicate that baricitinib may have an adverse effect on 
bone development in utero at higher dosages. 
 
Olumiant is contraindicated during pregnancy (see section 4.3). Women of childbearing potential have 
to use effective contraception during and for at least 1 week after treatment. If a patient becomes 
pregnant while taking Olumiant the parents should be informed of the potential risk to the foetus. 
 
Breast-feeding 
 
It is unknown whether baricitinib/metabolites are excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of baricitinib in milk (see 
section 5.3). 
 
A risk to newborns/infants cannot be excluded and Olumiant should not be used during breast-feeding. 
A decision must be made whether to discontinue breast-feeding or to discontinue Olumiant therapy 
taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility 
while on treatment, but there was no effect on male spermatogenesis (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Olumiant has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2 % of patients treated 
with Olumiant monotherapy or in combination with conventional synthetic DMARDs were increased 
LDL cholesterol (33.6 %), upper respiratory tract infections (14.7 %) and nausea (2.8 %). Infections 
reported with Olumiant treatment included Herpes zoster. 
 
Tabulated list of adverse reactions 
 
A total of 3,464 patients were treated with Olumiant in clinical studies in rheumatoid arthritis 
representing 4214 patient-years of exposure. Of these, 2166 rheumatoid arthritis patients were exposed 
to Olumiant for at least one year. Six placebo-controlled studies were integrated (997 patients on 4 mg 
once daily and 1070 patients on placebo) to evaluate the safety of Olumiant in comparison to placebo 
for up to 16 weeks after treatment initiation.  
 



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Table 2. Adverse Reactions  
Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 
to < 1/100). 
 

System Organ 
Class 

Very common Common Uncommon 

Infections and 
infestations 

Upper respiratory tract 
infectionsa 

Herpes zoster,  
Herpes simplexb 
Gastroenteritis 
Urinary tract infections 
Pneumonia 

 

Blood and 
lymphatic 
system disorders 

 Thrombocytosis 
>600 x 109 cells/Lc 

Neutropaenia 
<1 x 109 cells/Lc 
 

Metabolism and 
nutrition 
disorders 

Hypercholesterolaemiac  Hypertriglyceridaemiac 

Gastrointestinal 
disorders  

 Nausea  

Hepatobiliary 
disorders 

 ALT increased ≥3 x ULNc AST increased ≥3 x ULNc 

Skin and 
subcutaneous 
tissue disorders 

 Rash Acne 

Immune 
disorders 

  Swelling of the face, 
Urticaria 

Respiratory, 
thoracic, 
mediastinal 
disorders 

  Pulmonary embolism 

Vascular 
disorders 

  Deep Vein Thrombosis 

Investigations   Weight increased 
Creatine phosphokinase 
increased >5 x ULNc 

a Combined term (acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, 
pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract 
infection). 

b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes). 
c Includes changes detected during laboratory monitoring (see text below). 
 
Description of selected adverse reactions 
 
Nausea 
In treatment-naïve patients, through 52 weeks, the frequency of nausea was greater for the 
combination treatment of methotrexate and Olumiant (9.3 %) compared to methotrexate alone (6.2 %) 
or Olumiant alone (4.4 %). Nausea was most frequent during the first 2 weeks of treatment. 
 
Infections 
In controlled studies, for up to 16 weeks, the incidence rate of all infections (rate of patients with 
≥ 1 event per 100 patient-years of exposure) was 101 with Olumiant compared to 83 in the placebo 
group. Most infections were mild to moderate in severity. In studies which included both doses, 
infections were reported in 31.9%, 28.8% and 24.1% of patients up to 16 weeks in the 4 mg, 2 mg and 
placebo groups, respectively. Reporting rates for Olumiant compared to placebo for the 
infection-related ADRs were: Upper respiratory tract infections (14.7 % vs. 11.7 %), urinary tract 
infections (3.4 % vs. 2.7 %), gastroenteritis (1.6 % vs. 0.8 %), herpes simplex (1.8 % vs. 0.7 %), and 



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herpes zoster (1.4 % vs. 0.4 %). In treatment-naïve patients, for up to 52 weeks, the frequency of upper 
respiratory tract infections was greater for the combination treatment of methotrexate and Olumiant 
(26.0 %) compared to methotrexate alone (22.9 %) or Olumiant alone (22.0 %). The rate of serious 
infections with Olumiant (1.1 %) was similar to placebo (1.2 %). For Olumiant, the most common 
serious infections were herpes zoster, and cellulitis. The rate of serious infections remained stable 
during long term exposure. The overall incidence rate of serious infections in the clinical trial 
programme was 3.2 per 100 patient-years. 
 
Hepatic transaminase elevations 
In controlled studies, for up to 16 weeks, alanine transaminase (ALT) and aspartate transaminase 
(AST) elevations ≥ 3 x upper limit of normal (ULN) were observed in 1.4 % and 0.8 % of patients 
treated with Olumiant, compared to 1.0 % and 0.8 % respectively of patients treated with placebo. 
Most cases of hepatic transaminase elevations were asymptomatic and transient. 
 
In treatment-naïve patients, the combination of Olumiant with potentially hepatotoxic medicinal 
products, such as methotrexate, resulted in increased frequency of these elevations. For up to 
52 weeks, the frequency of ALT and AST elevations ≥ 3 x ULN were greater for the combination 
treatment of methotrexate and Olumiant (7.5 % and 3.8 %) compared to methotrexate alone (2.9 % 
and 0.5 %) or Olumiant alone (1.9 % and 1.3 %).  
 
The pattern and incidence of elevation in ALT/AST remained stable over time including in the long-
term extension study. 
 
Lipid elevations  
Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total 
cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. There was no change in the 
LDL/HDL ratio. Elevations were observed at 12 weeks and remained stable thereafter at a higher 
value than baseline including in the long-term extension study. In controlled studies, for up to 
16 weeks, the following rates were observed for Olumiant vs. placebo: 
 

• Increased total cholesterol ≥ 5.17 mmol/L: 49.1 % vs.15.8 %, respectively  
• Increased LDL cholesterol ≥ 3.36 mmol/L: 33.6 % vs. 10.3 %, respectively  
• Increased HDL cholesterol ≥ 1.55 mmol/L: 42.7 % vs. 13.8 %, respectively  
• Increased triglycerides ≥ 5.65 mmol/L: 0.4 % vs. 0.5 %, respectively  

 
In studies which included both doses, a dose-relationship was observed with increased total cholesterol 
≥ 5.17 mmol/L reported in 48.8 %, 34.7 % and 17.8 % of patients up to 16 weeks in the 4 mg, 2 mg 
and placebo groups, respectively. 
 
Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy. 
 
Creatine phosphokinase (CPK) 
In controlled studies, for up to 16 weeks, increases in CPK values were common. Significant increases 
(> 5 x ULN) occurred in 0.8 % of patients treated with Olumiant and 0.3 % of patients treated with 
placebo. A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 
1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively. 
Most cases were transient and did not require treatment discontinuation. In clinical trials, there were 
no confirmed cases of rhabdomyolysis. Elevations of CPK were observed at 4 weeks and remained 
stable at a higher value than baseline thereafter including in the long-term extension study. 
 
Neutropaenia 
In controlled studies, for up to 16 weeks, decreases in neutrophil counts below 1 x 109 cells/L occurred 
in 0.3 % of patients treated with Olumiant compared to 0 % of patients treated with placebo. There 
was no clear relationship between decreases in neutrophil counts and the occurrence of serious 
infections. However, in clinical studies, treatment was interrupted in response to ANC 



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< 1 x 109 cells/L. The pattern and incidence of decreases in neutrophil counts remained stable at a 
lower value than baseline over time including in the long-term extension study.  
 
Thrombocytosis 
In controlled studies, for up to 16 weeks, increases in platelet counts above 600 x 109 cells/L occurred 
in 2.0 % of patients treated with Olumiant 4 mg and 1.1 % of patients treated with placebo. No 
association was observed between increased platelet counts and adverse events of a thrombotic nature. 
The pattern and incidence of increases in platelet counts remained stable at a higher value than 
baseline over time including in the long term extension study. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered 
in clinical trials without dose-limiting toxicity. Adverse events were comparable to those seen at lower 
doses and no specific toxicities were identified. Pharmacokinetic data of a single dose of 40 mg in 
healthy volunteers indicate that more than 90 % of the administered dose is expected to be eliminated 
within 24 hours. In case of an overdose, it is recommended that the patient be monitored for signs and 
symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate 
treatment. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA37 
 
Mechanism of action 
 
Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. In isolated enzyme 
assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 
values of 5.9, 5.7, 53 and > 400 nM, respectively. 
 
Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a 
number of cytokines and growth factors involved in haematopoiesis, inflammation and immune 
function. Within the intracellular signalling pathway, JAKs phosphorylate and activate signal 
transducers and activators of transcription (STATs), which activate gene expression within the cell. 
Baricitinib modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic 
activity, thereby reducing the phosphorylation and activation of STATs. 
 
Pharmacodynamic effects 
 
Inhibition of IL-6 induced STAT3 phosphorylation 
Administration of baricitinib resulted in a dose dependent inhibition of IL-6 induced STAT3 
phosphorylation in whole blood from healthy subjects with maximal inhibition observed 2 hours after 
dosing which returned to near baseline by 24 hours.  
 

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Immunoglobulins 
Mean serum IgG, IgM, and IgA values decreased by 12 weeks after starting treatment with Olumiant, 
and remained stable at a lower value than baseline through at least 104 weeks. For most patients, 
changes in immunoglobulins occurred within the normal reference range. 
 
Lymphocytes 
Mean absolute lymphocyte count increased by 1 week after starting treatment with Olumiant, returned 
to baseline by week 24, and then remained stable through at least 104 weeks. For most patients, 
changes in lymphocyte count occurred within the normal reference range. 
 
C-reactive protein 
In patients with rheumatoid arthritis, decreases in serum C-reactive protein (CRP) were observed as 
early as 1 week after starting treatment with Olumiant and were maintained throughout dosing. 
 
Creatinine 
Baricitinib induced a mean increase in serum creatinine levels of 3.8  µmol/L after two weeks of 
treatment, as compared to placebo, which remained stable thereafter during up to 104  weeks of 
treatment. This may be due to inhibition of creatinine secretion by baricitinib in the renal tubules. 
Consequently, estimates of the glomerular filtration rate based on serum creatinine may be slightly 
reduced, without actual loss of renal function or the occurrence of renal adverse events. 
 
Vaccine study 
 
The influence of baricitinib on the humoral response to non-live vaccines was evaluated in 106 RA 
patients under stable treatment with baricitinib 2 or 4  mg, receiving inactivated pneumococcal or tetanus 
vaccination. The majority of these patients (n  =  94) were co-treated with methotrexate. For the total 
population, pneumococcal vaccination resulted in a satisfactory IgG immune response in 68.0  % 
(95  % CI: 58.4  %, 76.2  %) of the patients.  In 43.1  % (95  % CI: 34.0  %, 52.8  %) of the patients, a 
satisfactory IgG immune response to tetanus vaccination was achieved. 
 
Clinical efficacy 
 
The efficacy and safety of Olumiant once daily was assessed in 4 Phase III randomised, double-blind, 
multicentre studies in patients with moderate to severe active rheumatoid arthritis diagnosed according 
to the ACR/EULAR 2010 criteria (see Table 3). Patients over 18 years of age were eligible to 
participate. The presence of at least 6 tender and 6 swollen joints was required at baseline. All patients 
who completed these studies were eligible to enrol in a long term extension study for up to 4 years 
continued treatment. 
 
The RA-BEGIN Study in MTX-naïve patients is supportive for the target population of patients with 
an inadequate response to, or intolerance to, other DMARDs (section 4.1). 
 



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Table 3. Clinical Trial Summary 
 
Study name 
(Duration) 

Population  
(Number) 

Treatment arms Summary of key outcome measures 

RA-BEGIN 
(52 weeks) 

MTX-naïve1 
(584) 
 

• Olumiant 4 mg QD 
• Olumiant 4 mg QD + MTX 
• MTX 

• Primary endpoint: ACR20 at week 24 
• Physical function (HAQ-DI) 
• Radiographic progression (mTSS) 
• Low disease activity and Remission (SDAI) 

RA-BEAM 
(52 weeks) 

MTX-IR2 
(1305) 
 

• Olumiant 4 mg QD  
• Adalimumab 40 mg SC Q2W  
• Placebo 
 
All patients on background MTX 

• Primary endpoint:ACR20 at week 12 
• Physical function (HAQ-DI) 
• Radiographic progression (mTSS) 
• Low disease activity and Remission (SDAI) 
• Morning Joint Stiffness 

RA-BUILD 
(24 weeks) 

cDMARD-IR3 
(684) 
 

• Olumiant 4 mg QD  
• Olumiant 2 mg QD  
• Placebo 
 
On background cDMARDs5 if on 
stable cDMARD at study entry 

• Primary endpoint: ACR20 at week 12 
• Physical function (HAQ-DI) 
• Low disease activity and remission (SDAI) 
• Radiographic progression (mTSS) 
• Morning Joint Stiffness 

RA-
BEACON 
(24 weeks) 

TNF-IR4 
(527) 
 

• Olumiant 4 mg QD 
• Olumiant 2 mg QD  
• Placebo  
 
On background cDMARDs5 

• Primary endpoint: ACR20 at week 12 
• Physical function (HAQ-DI) 
• Low disease activity and Remission (SDAI) 
 

Abbreviations: QD = Once daily; Q2W = Once every 2 weeks; SC = Subcutaneously; ACR = 
American College of Rheumatology; SDAI = Simplified Disease Activity Index; HAQ-DI = Health 
Assessment Questionnaire-Disability Index; mTSS = modified Total Sharp Score 
 

1 Patients who had received less than 3 doses of Methotrexate (MTX); naïve to other conventional or 
biologic DMARDs 
2 Patients who had an inadequate response to MTX (+/- other cDMARDs); biologic-naïve 
3 Patients who had an inadequate response or were intolerant to ≥ 1 cDMARDs; biologic- naïve 
4 Patients who had an inadequate response or were intolerant to ≥ 1 bDMARDs; including at least one 
TNF inhibitor 
5 Most common concomitant cDMARDs included MTX, hydroxychloroquine, leflunomide and 
sulfasalazine 
 
Clinical Response 
In all studies, patients treated with Olumiant 4 mg once daily had statistically significantly higher 
ACR20, ACR50 and ACR70 response at 12 weeks compared to placebo, MTX or adalimumab (see 
Table 4).Time to onset of efficacy was rapid across measures with significantly greater responses seen 
as early as week 1. Continued, durable response rates were observed, with ACR20/50/70 responses 
maintained for at least 2 years including the long-term extension study. 
 
Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in significant 
improvements in all individual ACR components, including tender and swollen joint counts, patient 
and physician global assessments, HAQ-DI, pain assessment and CRP, compared to placebo or MTX 
monotherapy. In RA-BEAM, treatment with Olumiant resulted in significant improvement in patient 
and physician global assessments, HAQ-DI, pain assessment and CRP at Weeks 12, 24 and 52 
compared to adalimumab.  
 
In placebo-controlled trials in which MTX was not required, 501 subjects randomized to baricitinib 
2 mg or 4 mg received MTX as background therapy, and 303 received conventional DMARDs other 
than MTX (approximately half with MTX and half without). The most common concomitant 
DMARDs in these subjects were MTX (79% of patients), hydroxychloroquine (19%), leflunomide 



13 

(11%), and sulphasalazine (9%). No relevant differences regarding efficacy and safety were observed 
in subgroups defined by types of concomitant DMARDs used in combination with baricitinib. 
 
Remission and low disease activity 
A statistically significantly greater proportion of patients treated with Olumiant 4 mg compared to 
placebo or MTX achieved remission, as defined by SDAI ≤ 3.3 and CDAI ≤ 2.8, at weeks 12 and 24 
(Table 4).  
 
In all 4 studies, a significantly higher proportion of patients treated with Olumiant 4 mg compared to 
placebo or MTX achieved low disease activity or remission (DAS28-ESR or DAS28-hsCRP ≤ 3.2 and 
DAS28-ESR or DAS28-hsCRP < 2.6) at Weeks 12 and 24.  
 
Greater rates of remission compared to placebo were observed as early as week 4. Including data from 
a long-term extension study, remission and low disease activity rates were maintained for at least 
2 years. 
 



14 

Table 4: Response, Remission and Physical Function 
 

Study RA-BEGIN 
MTX-naïve patients 

RA-BEAM 
MTX-IR patients 

RA-BUILD 
cDMARD-IR patients 

RA-BEACON 
TNF-IR patients 

Treatment 
group 

MTX OLU 
4 mg 

OLU 
4 mg 

+ MTX 

PBO 
 
 

OLU 
4 mg 

 

ADA 
40 mg 
Q2W 

PBO OLU 
2 mg 

OLU 
4 mg 

PBO 
 

OLU 
2 mg 

 

OLU 
4 mg 

 
N 210 159 215 488 487 330 228 229 227 176 174 177 
ACR20: 
Week 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** 
Week 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** 
Week 52 56 % 73 %*** 73 %***  71 %†† 62 %       
ACR50: 
Week 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** 
Week 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** 
Week 52 38 % 57 %*** 62 %***  56 %† 47 %       
ACR70: 
Week 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** 
Week 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** 
Week 52 25 % 42 %*** 46 %***  37 % 31 %       
DAS28-hsCRP ≤ 3.2: 
Week 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** 
Week 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** 
Week 52 38 % 57 %*** 63 %***  56 %† 48 %       
DAS28-ESR ≤ 3.2: 
Week 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** 
Week 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** 
Week 52 27 % 36 % 45 %***  39 % 36 %       
SDAI ≤ 3.3: 
Week 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % 
Week 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** 
Week 52 13 % 25 %** 30 %***  23 % 18 %       
CDAI ≤ 2.8: 
Week 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % 
Week 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* 
Week 52 16 % 25 %* 28 %**  22 % 18 %       
HAQ-DI Minimum Clinically Important Difference (decrease in HAQ-DI score of ≥ 0.30): 
Week 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** 
Week 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** 
Week 52 53 % 65 %* 67 %**   61 % 55 %       
Note: Proportions of responders at each time point based on those initially randomised to treatment 
(N). Patients who discontinued or received rescue therapy were considered as non-responders 
thereafter. 
Abbreviations: ADA = adalimumab; MTX = methotrexate; OLU = Olumiant; PBO = Placebo 
* p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. placebo (vs. MTX for study RA-BEGIN) 
† p ≤ 0.05; †† p ≤ 0.01; ††† p ≤ 0.001 vs. adalimumab 
 
 
 



15 

Radiographic response 
The effect of Olumiant on progression of structural joint damage was evaluated radiographically in 
studies RA-BEGIN, RA-BEAM and RA-BUILD and assessed using the modified Total Sharp Score 
(mTSS) and its components, the erosion score and joint space narrowing score.  
 
Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of 
structural joint damage (Table 5). Analyses of erosion and joint space narrowing scores were 
consistent with the overall scores. The proportion of patients with no radiographic progression (mTSS 
change ≤ 0) was significantly higher with Olumiant 4 mg compared to placebo at weeks 24 and 52. 
 
Table 5. Radiographic Changes  
 

Study RA-BEGIN 
MTX-naïve patients 

RA-BEAM 
MTX-IR patients 

RA-BUILD 
cDMARD-IR patients 

Treatment 
group 

MTX OLU 
4 mg  

OLU 
4 mg  
+ MTX 

PBOa 
 
 

OLU 
4 mg  
 

ADA 
40 mg 
Q2W 

PBO OLU 
2 mg 

OLU 
4 mg 

Modified Total Sharp Score, mean change from baseline: 
Week 24 0.61 0.39 0.29* 0.90 0.41*** 0.33*** 0.70 0.33* 0.15** 
Week 52 1.02 0.80 0.40** 1.80 0.71*** 0.60***    
Erosion Score, Mean change from baseline: 
Week 24 0.47 0.33 0.26* 0.61 0.29*** 0.24*** 0.47 0.30 0.11** 
Week 52 0.81 0.55 0.34** 1.23 0.51*** 0.42***    
Joint Space Narrowing Score, mean change from baseline: 
Week 24 0.14 0.06 0.03 0.29 0.12** 0.10** 0.23 0.03* 0.04* 
Week 52 0.21 0.25 0.06 0.58 0.21*** 0.19**    
Proportion of patients with no radiographic progressionb: 
Week 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % 
Week 52 66 % 69 % 80 %** 70 % 79 %** 81 %**    

Abbreviations: ADA = adalimumab; MTX = methotrexate; OLU = Olumiant; PBO = Placebo  
a Placebo data at week 52 derived using linear extrapolation 
b No progression defined as mTSS change ≤ 0.  
* p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. placebo (vs. MTX for study RA-BEGIN) 
 
Physical function response and health-related outcomes  
Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant 
improvement in physical function compared to all comparators (placebo, MTX, adalimumab), as 
measured by HAQ-DI, at 12, 24 and 52 weeks. The proportion of patients achieving a clinically 
significant improvement (HAQ-DI ≥ 0.30) was also higher with Olumiant compared to placebo or 
MTX at week 12 (Table 4). Improvements were seen as early as Week 1 and, in studies RA-BEGIN 
and RA-BEAM, this was maintained for up to 52 weeks.  
 
Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant 
improvement in pain compared to all comparators (placebo, MTX, adalimumab), as measured on a 
0-100 visual analogue scale, at 12 weeks. Statistically significant pain reduction was seen as early as 
Week 1 and in studies RA-BEGIN and RA-BEAM this was maintained for up to 52 weeks.  
 
In RA-BEAM and RA-BUILD, treatment with Olumiant 4 mg resulted in a significant improvement 
in the mean duration and severity of morning joint stiffness compared to placebo or adalimumab as 
assessed using daily electronic patient diaries for 12 weeks. 
 
In all studies, Olumiant-treated patients reported improvements in patient-reported quality of life, as 
measured by the Short Form (36) Health Survey (SF-36) Physical Component Score and fatigue, as 
measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F). 
 
Olumiant 4 mg vs. 2 mg 
Differences in efficacy between the 4 mg and the 2 mg doses were most notable in the bDMARD-IR 
population (RA-BEACON), in which statistically significant improvements in the ACR components of 



16 

swollen joint count, tender joint count and ESR were shown for Olumiant 4 mg compared to placebo 
at Week 24 but not for Olumiant 2 mg compared to placebo. In addition, for both study RA-BEACON 
and RA-BUILD, onset of efficacy was faster and the effect size was generally larger for the 4 mg dose 
groups compared to 2 mg.  
 
In a long-term extension study, patients from Studies RA-BEAM, RA-BUILD and RA-BEACON who 
achieved sustained low disease activity or remission (CDAI ≤ 10) after at least 15 months of treatment 
with Olumiant 4 mg once daily were re-randomized 1:1 in a double-blind manner to continue 4 mg 
once daily or reduce dose to 2 mg once daily. The majority of patients maintained low disease activity 
or remission based on CDAI score: 

• At week 12: 234/251 (93 %) continuing 4 mg vs. 207/251 (82 %) reduced to 2 mg (p ≤ 0.001) 
• At week 24: 163/191 (85 %) continuing 4 mg vs. 144/189 (76 %) reduced to 2 mg (p ≤ 0.05) 
• At week 48: 57/73 (78 %) continuing 4 mg vs. 51/86 (59 %) reduced to 2 mg (p ≤ 0.05) 

 
The majority of patients who lost their low disease activity or remission status after dose reduction 
could regain disease control after the dose was returned to 4 mg. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Olumiant in one or more subsets of the paediatric population in chronic idiopathic arthritis (see 
section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Following oral administration of baricitinib, a dose-proportional increase in systemic exposure was 
observed in the therapeutic dose range. The PK of baricitinib is linear with respect to time. 
 
Absorption 
 
Following oral administration, baricitinib is rapidly absorbed with a median tmax of approximately 
1 hour (range 0.5 - 3.0 h) and an absolute bioavailability of approximately 79 % (CV = 3.94 %). Food 
intake led to a decreased exposure by up to 14 %, a decrease in Cmax by up to 18 % and delayed tmax by 
0.5 hours. Administration with meals was not associated with a clinically relevant effect on exposure. 
 
Distribution 
 
Mean volume of distribution following intravenous infusion administration was 76 L, indicating 
distribution of baricitinib into tissues. Baricitinib is approximately 50 % bound to plasma proteins.  
 
Biotransformation 
 
Baricitinib metabolism is mediated by CYP3A4, with less than 10 % of the dose identified as 
undergoing biotransformation. No metabolites were quantifiable in plasma. In a clinical pharmacology 
study, baricitinib was excreted predominately as the unchanged active substance in urine (69 %) and 
faeces (15 %) and only 4 minor oxidative metabolites were identified (3 in urine; 1 in faeces) 
constituting approximately 5 % and 1 % of the dose, respectively. In vitro, baricitinib is a substrate for 
CYP3A4, OAT3, Pgp, BCRP and MATE2-K, and may be a clinically relevant inhibitor of the 
transporter OCT1 (see section 4.5). Baricitinib is not an inhibitor of the transporters OAT1, OAT2, 
OAT3, OCT2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant 
concentrations.  
 
Elimination 
 
Renal elimination is the principal mechanism for baricitinib’s clearance through glomerular filtration 
and active secretion via OAT3, Pgp, BCRP and MATE2-K. In a clinical pharmacology study, 
approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the 



17 

dose was eliminated in the faeces. Mean apparent clearance (CL/F) and half-life in patients with 
rheumatoid arthritis was 9.42 L/hr (CV = 34.3 %) and 12.5 hrs (CV = 27.4 %), respectively. Cmax and 
AUC at steady state are 1.4- and 2.0–fold higher, respectively, in subjects with rheumatoid arthritis 
compared to healthy subjects.  
 
Renal Impairment 
 
Renal function was found to significantly affect baricitinib exposure. The mean ratios of AUC in 
patients with mild and moderate renal impairment to patients with normal renal function are 1.41 
(90 % CI: 1.15-1.74) and 2.22 (90 % CI: 1.81-2.73), respectively. The mean ratios of Cmax in patients 
with mild and moderate renal impairment to patients with normal renal function are 1.16 
(90 %CI: 0.92-1.45) and 1.46 (90 %CI: 1.17-1.83), respectively. See section 4.2 for dose 
recommendations.  

 
Hepatic Impairment 
 
There was no clinically relevant effect on the PK of baricitinib in patients with mild or moderate 
hepatic impairment. The use of baricitinib has not been studied in patients with severe hepatic 
impairment. 
 
Elderly 
 
Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC). 
 
Paediatric population 
 
The safety, efficacy and pharmacokinetics of baricitinib have not yet been established in a paediatric 
population (see section 4.2). 
 
Other intrinsic Factors 
 
Body weight, sex, race, and ethnicity did not have a clinically relevant effect on the PK of baricitinib. 
The mean effects of intrinsic factors on PK parameters (AUC and Cmax) were generally within the 
inter-subject PK variability of baricitinib. Therefore, no dose adjustment is needed based on these 
patient factors. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, genotoxicity and carcinogenic potential. 
 
Decreases in lymphocytes, eosinophils and basophils as well as lymphoid depletion in organs/tissues 
of the immune system were observed in mice, rats and dogs. Opportunistic infections related to 
demodicosis (mange) were observed in dogs at exposures approximately 7 times the human exposure. 
Decreases in red blood cell parameters were observed in mice, rats and dogs at exposures 
approximately 6 to 36 times the human exposure. Degeneration of the sternal growth plate was 
observed in some dogs, at low incidence and also in control animals, but with a dose-effect 
relationship regarding severity. At present it is not known whether this is clinically relevant. 
 
In rat and rabbit reproductive toxicology studies, baricitinib was shown to reduce foetal growth/weight 
and produce skeletal malformations (at exposures of approximately 10 and 39 times the human 
exposure, respectively). No adverse foetal effects were observed at exposures 2 times the human 
exposure based on AUC. 
 
In a combined male/female rat fertility study, baricitinib decreased overall mating performance 
(decreased fertility and conception indices). In female rats there were decreased numbers of corpora 
lutea and implantation sites, increased pre-implantation loss, and/or adverse effects on intrauterine 



18 

survival of the embryos. Since there were no effects on spermatogenesis (as assessed by 
histopathology) or semen/sperm endpoints in male rats, the decreased overall mating performance was 
likely the result of these female effects. 
 
Baricitinib was detected in the milk of lactating rats. In a pre- and postnatal development study, 
decreased pup weights and decreased postnatal survival were observed at exposures 4 and 21 times, 
respectively, the human exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet cores 
 

• cellulose, microcrystalline  
• croscarmellose sodium  
• magnesium stearate  
• mannitol  

 
Film coating 
 

• iron oxide red (E172) 
• lecithin (soya) (E322) 
• macrogol 
• poly (vinyl alcohol) 
• talc 
• titanium dioxide (E171) 

 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions 
 
6.5 Nature and contents of container 
 
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium blisters in cartons of 14, 28, 
35, 56, 84 or 98 film-coated tablets. 
 
Polyvinylchloride/aluminium/oriented polyamide - aluminium perforated unit dose blisters in cartons 
of 28 x 1 or 84 x 1 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal. 
 
 



19 

7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Olumiant 2 mg film-coated tablets 
EU/1/16/1170/001 
EU/1/16/1170/002 
EU/1/16/1170/003 
EU/1/16/1170/004 
EU/1/16/1170/005 
EU/1/16/1170/006 
EU/1/16/1170/007 
EU/1/16/1170/008 
 

Olumiant 4 mg film-coated tablets 
 
EU/1/16/1170/009 
EU/1/16/1170/010 
EU/1/16/1170/011 
EU/1/16/1170/012 
EU/1/16/1170/013 
EU/1/16/1170/014 
EU/1/16/1170/015 
EU/1/16/1170/016 

 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first Authorisation: 13 February 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



21 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Lilly S.A. 
Avda. de la Industria, 30 
Alcobendas 
28108 Madrid 
SPAIN 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  

 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation. 

 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the  
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

 
• Additional risk minimisation measures 

 
Prior to launch of Olumiant in each Member State, the Marketing Authorisation Holder (MAH) must 
agree about the content and format of the educational materials, including communication media, 
distribution modalities, and any other aspects of the programme, with the National Competent 
Authority.  
 
The main objectives of the programme are to make the prescribers aware of the risks associated with 
the product’s use, and to highlight specific risk minimisation measures to be performed before and 
during the treatment with Olumiant.  



22 

The MAH shall ensure that, in each Member State where Olumiant is marketed, all healthcare 
professionals who are expected to prescribe Olumiant are provided with the physician educational 
material, which should contain:  

• The Summary of Product Characteristics 
• The Package Leaflet including the Patient Alert Card 
• The guide for healthcare professionals to support counselling of the patient 
• Additional Patient Alert Cards 

 
The guide for healthcare professionals shall contain the following key elements: 

• That Olumiant increases the potential risk of infections. Patients should be instructed to seek 
immediate medical attention, if signs or symptoms suggesting infection appear. 

• That Olumiant use should be stopped in case of herpes zoster or any other infection that 
doesn’t respond to standard treatment until the event resolves. Patients should not be 
immunised using live attenuated vaccines shortly before or during treatment with Olumiant. 

• Prescribers should screen the patients for viral hepatitis before commencing Olumiant 
treatment. Active tuberculosis should also be ruled out.  

• That Olumiant use is associated with hyperlipidaemia; prescribers should monitor the patient’s 
lipid parameters and manage the hyperlipidaemia, if detected.  

• That Olumiant is contraindicated in pregnancy as pre-clinical data showed reduced foetal 
growth and malformations. Physicians should advise women of child bearing potential to use 
contraception during treatment and for a week after its ending. If a planned pregnancy is 
considered, Olumiant treatment should be stopped. 

• The purpose and use of the Patient Alert Card 
 
The patient alert card shall contain the following key messages:  

• That treatment with Olumiant may increase the risk of infections, and viral reactivation. 
• Signs or symptoms of infections including general symptoms, and specifically tuberculosis 

and herpes zoster signs and symptoms; and a warning for the patients to seek immediate 
medical attention if signs or symptoms suggesting infection appear 

• That Olumiant should not be taken while pregnant and that women should inform their doctor 
should they become (or wish to become) pregnant 

• That the patient may need to have their cholesterol level checked during treatment 
• Contact details of the prescriber  
• That the Patient Alert Card should be carried by the patient at any time and to share it with 

other healthcare professionals involved in their treatment. 
 
 

  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTONS FOR 2 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 2 mg film-coated tablets 
baricitinib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 2 mg baricitinib 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
28 x 1 film-coated tablets 
84 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
QR code to be included+ www.olumiant.eu 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 

http://www.olumiant.eu/


26 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands. 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 

EU/1/16/1170/001 (14 film-coated tablets) 
EU/1/16/1170/002 (28 film-coated tablets) 
EU/1/16/1170/003 (28 x 1 film-coated tablets) 
EU/1/16/1170/004 (35 film-coated tablets) 
EU/1/16/1170/005 (56 film-coated tablets) 
EU/1/16/1170/006 (84 film-coated tablets) 
EU/1/16/1170/007 (84 x 1 film-coated tablets) 
EU/1/16/1170/008 (98 film-coated tablets) 

 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Olumiant 2 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



27 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
CALENDAR BLISTERS NON-PERFORATED FOR 2 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 2 mg tablets  
baricitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Lilly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 



28 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS PERFORATED UNIT DOSE FOR 2 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 2 mg tablets  
baricitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Lilly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



29 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTONS FOR 4 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 4 mg film-coated tablets  
baricitinib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 4 mg baricitinib 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
35 film-coated tablets 
56 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
28 x 1 film-coated tablets 
84 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
QR code to be included+ www.olumiant.eu 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 

http://www.olumiant.eu/


30 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands. 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 

EU/1/16/1170/009 (14 film-coated tablets) 
EU/1/16/1170/010 (28 film-coated tablets) 
EU/1/16/1170/011 (28 x 1 film-coated tablets) 
EU/1/16/1170/012 (35 film-coated tablets) 
EU/1/16/1170/013 (56 film-coated tablets) 
EU/1/16/1170/014 (84 film-coated tablets) 
EU/1/16/1170/015 (84 x 1 film-coated tablets) 
EU/1/16/1170/016 (98 film-coated tablets) 

 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Olumiant 4 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



31 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
CALENDAR BLISTERS NON-PERFORATED FOR 4 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 4 mg tablets  
baricitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Lilly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 
 
 



32 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS PERFORATED UNIT DOSE FOR 4 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Olumiant 4 mg tablets  
baricitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Lilly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



34 

Package leaflet: Information for the patient 
 

Olumiant 2 mg film-coated tablets 
Olumiant 4 mg film-coated tablets 

Baricitinib 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, or pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Olumiant is and what it is used for  
2. What you need to know before you take Olumiant  
3. How to take Olumiant 
4. Possible side effects  
5. How to store Olumiant  
6. Contents of the pack and other information 
 
 
1. What Olumiant is and what it is used for 
 
Olumiant contains the active substance baricitinib. It belongs to a group of medicines called Janus 
kinase inhibitors, which help to reduce inflammation.  
 
Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory disease 
of the joints, if previous therapy did not work well enough or was not tolerated. Olumiant can be used 
alone or together with some other medicines, such as methotrexate. 
 
Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is 
involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to reduce pain, 
stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in 
the joints. These effects can help you to do normal daily activities and so improve the health-related 
quality of life for patients with rheumatoid arthritis. 
 
 
2. What you need to know before you take Olumiant 
 
Do not take Olumiant: 
- if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in 

section 6). 
- if you are pregnant or think you may be pregnant. 
 
Warnings and precautions  
Talk to your doctor or pharmacist before and during treatment with Olumiant if you: 
- have an infection, or if you often get infections. Tell your doctor if you get symptoms such as 

fever, wounds, feeling more tired than usual or dental problems as these can be signs of 



35 

infection. Olumiant can reduce your body’s ability to fight infections and may make an existing 
infection worse or increase the chance of you getting a new infection 

- have, or have previously had, tuberculosis. You may need tests to check for tuberculosis before 
you are given Olumiant. Tell your doctor if you get persistent cough, fever, night sweats and 
weight loss during Olumiant treatment as these can be signs of tuberculosis 

- have had a herpes infection (shingles), because Olumiant may allow it to come back. Tell your 
doctor if you get painful skin rash with blisters during Olumiant treatment as these can be signs 
of shingles 

- have, or have previously had, hepatitis B or C 
- are due to have a vaccine. You should not be given certain (live) vaccines while using Olumiant 
- have cancer, because your doctor will have to decide if you can still be given Olumiant 
- have poor liver function 
- have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs 

(pulmonary embolism). Tell your doctor if you get a painful swollen leg, chest pain, or 
shortness of breath as these can be signs of blood clots in the veins 

- If you notice any of the following serious side effects you need to tell a doctor straight away: 
- chest tightness  
- wheezing  
- severe dizziness or light-headedness  
- swelling of the lips, tongue or throat 
- hives (itching or skin rash) 

 
You may  need blood tests before you start Olumiant, or while you are  taking it, to check if you have 
a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), high 
blood fat (cholesterol) or high levels of liver enzymes, to ensure that treatment with Olumiant is not 
causing problems.  
 
Children and adolescents 
Olumiant is not for use in children and adolescents under 18 years old because there is no information 
on use in this age group. 
 
Other medicines and Olumiant 
Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other 
medicines. 
 
In particular, tell your doctor or pharmacist before taking Olumiant if you are taking: 
- probenecid (for gout), since this medicine may increase the levels of Olumiant in your blood. If 

you are taking probenecid, the recommended dose of Olumiant is 2 mg once a day 
- injectable anti-rheumatic medicine 
- medicines which are used to control the body’s immune response, such as azathioprine, 

tacrolimus or ciclosporin 
- other medicines belonging to the group of Janus kinase inhibitors, such as ruxolitinib  
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
You should use an effective method of contraception to avoid becoming pregnant during treatment 
with Olumiant and for at least one week after the last Olumiant treatment. You must tell your doctor if 
you become pregnant as Olumiant should not be used during pregnancy.  
 
You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk. 
You and your doctor should decide if you will breast-feed or use Olumiant. You should not do both. 
 
Driving and using machines 
Olumiant has no effect on the ability to drive and use machines. 
 



36 

 
3. How to take Olumiant 
 
Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid 
arthritis. Always take this medicine exactly as your doctor or pharmacist has told you. Check with 
your doctor or pharmacist if you are not sure.  
 
The recommended dose is 4 mg once a day. Your doctor may give you a lower dose of 2 mg once a 
day, particularly if you are over 75 years old or if you have an increased risk of infections. If the 
medicine is working well, your doctor may decide the dose can be reduced.  
 
If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once a day. 
 
Olumiant is for oral use. You should swallow your tablet with a drink of water.  
You can take the tablets either with or without food. To help you remember to take Olumiant, you may 
find it easier to take it at the same time every day. 
 
If you take more Olumiant than you should 
If you take more Olumiant than you should, contact your doctor. You may get some of the side effects 
described in section 4. 
 
If you forget to take Olumiant 
- If you miss a dose, take it as soon as you remember.  
- If you forget your dose for an entire day, just skip the missed dose and take only a single dose as 

usual the following day.  
- Do not take a double dose to make up for a forgotten tablet. 
 
If you stop taking Olumiant  
Do not stop taking Olumiant unless your doctor tells you to stop taking it. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Infection such as shingles, which may affect up to 1 in 10 people: 
Tell your doctor or seek medical help immediately if you get the following symptoms, which may be 
signs of shingles (herpes zoster):  
- painful skin rash with blisters and fever 
 
Very common side effects (may affect more than 1 in 10 people): 
- throat and nose infections 
- high levels of blood fat (cholesterol) shown by blood test 
 
Common side effects (may affect up to 1 in 10 people): 
- cold sores (herpes simplex)  
- infection causing a sick stomach or diarrhoea (gastroenteritis) 
- urinary infection 
- pneumonia 
- high number of platelets (cells involved in blood clotting), shown by blood test 
- feeling sick in the stomach (nausea) 
- high levels of liver enzymes, shown by blood test 
- rash 
 



37 

Uncommon side effects (may affect up to 1 in 100 people): 
- low number of white bloods cells (neutrophils), shown by blood test 
- increase in an enzyme called creatine kinase, shown by blood test 
- high levels of blood fat (triglycerides), shown by blood test 
- acne 
- weight gain 
- swelling of the face 
- urticaria 
- blood clots in the blood vessels of the lungs 
- blood clot in the veins of the legs or pelvis, called a deep vein thrombosis (DVT) 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Olumiant 
 
Keep this medicine out of the sight and reach of children. 
This medicine does not require any special storage conditions. 
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. 
The expiry date refers to the last day of that month. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Olumiant contains  
- The active substance is baricitinib. Each tablet contains 2 or 4 milligrams of baricitinib.  
 
- The other ingredients are: microcrystalline cellulose, croscarmellose sodium, magnesium 

stearate, mannitol, iron oxide red (E172), lecithin (soya) (E322), macrogol, poly (vinyl alcohol), 
talc and titanium dioxide (E171).  

 
What Olumiant looks like and contents of the pack 
Olumiant 2 mg film-coated tablets are light pink, oblong tablets, with “Lilly” on one side and “2” on 
the other.  
 
Olumiant 4 mg film-coated tablets are medium pink, round tablets, with “Lilly” on one side and “4” on 
the other. 
 
The tablets are rounded and have hollow sides to help you pick them up. 
 
Olumiant 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84 and 98 tablets in calendar 
blisters and 28 x 1 and 84 x 1 tablets in perforated unit dose blisters. Not all the pack sizes may be 
marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The 
Netherlands.  
 
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
  
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Lietuva 
Eli Lilly Holdings Limited atstovybė 
Tel. +370 (5) 2649600 

 
България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 

 
Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

 
Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 

 
Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

 
Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 

 
Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

 
Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

 
Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Holdings Limited Eesti filiaal  
Tel: +372 6 817 280 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 
 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France SAS 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

SLOVENIJA 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia, s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 
 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 



39 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly Holdings Limited pārstāvniecība Latvijā 
Tel: +371 67364000 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
QR code to be included + www.olumiant.eu 
 
 
Please remove this portion of the patient leaflet and keep it with you. 
 
-------------------------------------------------------------------------------------------------------------------------- 
 
 

 
Information for Patients about OLUMIANT® 
(baricitinib) 
This document contains important 
information you should be aware of before and 
during treatment with Olumiant. 
 
 
Keep this information with you and share it with 
other  healthcare professionals involved in your 
medical care or treatment. 
 
 
Your name: 
 
_______________________________________ 
 
Doctor’s name (who prescribed Olumiant): 
 
_______________________________________ 
 
Doctor’s phone number: 
 
_______________________________________ 

 
Pregnancy 
• Do not take Olumiant if you are pregnant 

or suspect you may be pregnant.  
• Use effective contraception while taking 

Olumiant (and for 1 week after, if you 
stop treatment). 

• Tell your doctor immediately if you 
become (or wish to become) pregnant. 
 

 
Infections: 
Olumiant may make an existing infection 
worse or increase the chance of you getting a 
new infection or increase the chance of viral 
reactivation. Inform your doctor immediately if 
you get symptoms of infection, such as: 
• Fever, wounds, feeling more tired than 

usual, or dental problems. 
• A cough that won't go away, night sweats, 

and weight loss. These could be 
symptoms of tuberculosis (an infectious 
disease of the lungs).  

• A painful skin rash with blisters. This 
could be a sign of a herpes zoster 
infection. 

 
Blood fat: 
Your doctor may check for levels of fat in the 
blood, such as cholesterol, while you are taking 
Olumiant. 

 
  

http://www.olumiant.eu/


40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annex IV 
Scientific conclusions and grounds for the variation to the terms of the marketing 

authorisation(s) 
 
 
 
 

 



41 

Scientific conclusions 
 
Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific 
conclusions of CHMP are as follows:  
 
An imbalance in reports of VTE with 0% (EAIR of 0,0) for placebo vs. 0,53% (EAIR of 1,3) for 
baricitinib 4-mg was noted in placebo-controlled trials. VTE reporting rate is increasing. In July 2019 
VTE reporting rate was 0,13% compared to 0,09% in February 2019. As of 01 July 2019, 114 VTEs 
have been reported in 102 cases from post-marketing reports. Moreover, recurrent DVT and 
subsequent PE observed September 2018 in patient who continued treatment with baricitinib after the 
first DVT also confirm possible relationship between use of baricitinib and occurrence of VTE. 
Therefore, the PRAC requests the MAH to update section 4.4 of the SmPC to modify the wording on 
“Venous Thromboembolism” to indicate that if clinical features of DVT/PE occur, baricitinib 
treatment should be discontinued and to update section 4.8 of the SmPC to add the adverse reaction 
pulmonary embolism and deep vein thrombosis with a frequency not known.  
 
Data from clinical studies shows that the incidence rate of urticaria and face oedema is higher in the 
baricitinib 4 mg arm [urticarial: 0.60; face oedema: 0.89] compared to placebo arm [urticarial: 0.29; 
face oedema:0.29]. From the 316 events included for review from post-marketing reports, rash (n=95) 
was the most frequently reported event. Swelling face (n=23) and urticaria (n=20) were also frequently 
reported. From the 316 events retrieved as of 13 May 2019, 78 were categorised as systemic/oedema 
and 38 were categorised as non-specific. Taking into account information provided by MAH, at least 
part of non-specific events were indeed systemic however due the limited information it is not possible 
to categorise them properly. Moreover positive dechallenge (e.g. one case categorised as systemic) and 
positive dechallenge and rechallenge (e.g. one case categorised as non-specific) also support the view 
that baricitinib may cause systemic events. Therefore, the PRAC requests the MAH to update of 
section 4.4 of the SmPC to add a warning on hypersensitivity and to update of Section 4.8 to add the 
adverse reactions “rash” with a frequency common and “swelling of the face, urticaria” with a 
frequency uncommon.  
 
The CHMP agrees with the scientific conclusions made by the PRAC. 
 
Grounds for the variation to the terms of the marketing authorisation(s) 
 
On the basis of the scientific conclusions for baricitinib the CHMP is of the opinion that the benefit-
risk balance of the medicinal product(s) containing baricitinib is unchanged subject to the proposed 
changes to the product information 
 
The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
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{'Title': '2. what you need to know before you take olumiant', 'Section_Content': "do not take olumiant: - if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6). - if you are pregnant or think you may be pregnant. warnings and precautions talk to your doctor or pharmacist before and during treatment with olumiant if you: - have an infection, or if you often get infections. tell your doctor if you get symptoms such as fever, wounds, feeling more tired than usual or dental problems as these can be signs of 35 infection. olumiant can reduce your body's ability to fight infections and may make an existing infection worse or increase the chance of you getting a new infection - have, or have previously had, tuberculosis. you may need tests to check for tuberculosis before you are given olumiant. tell your doctor if you get persistent cough, fever, night sweats and weight loss during olumiant treatment as these can be signs of tuberculosis - have had a herpes infection (shingles), because olumiant may allow it to come back. tell your doctor if you get painful skin rash with blisters during olumiant treatment as these can be signs of shingles - have, or have previously had, hepatitis b or c - are due to have a vaccine. you should not be given certain (live) vaccines while using olumiant - have cancer, because your doctor will have to decide if you can still be given olumiant - have poor liver function - have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins - if you notice any of the following serious side effects you need to tell a doctor straight away: - chest tightness - wheezing - severe dizziness or light-headedness - swelling of the lips, tongue or throat - hives (itching or skin rash) you may need blood tests before you start olumiant, or while you are taking it, to check if you have a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), high blood fat (cholesterol) or high levels of liver enzymes, to ensure that treatment with olumiant is not causing problems. children and adolescents olumiant is not for use in children and adolescents under 18 years old because there is no information on use in this age group. other medicines and olumiant tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines. in particular, tell your doctor or pharmacist before taking olumiant if you are taking: - probenecid (for gout), since this medicine may increase the levels of olumiant in your blood. if you are taking probenecid, the recommended dose of olumiant is 2 mg once a day - injectable anti-rheumatic medicine - medicines which are used to control the body's immune response, such as azathioprine, tacrolimus or ciclosporin - other medicines belonging to the group of janus kinase inhibitors, such as ruxolitinib pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. you should use an effective method of contraception to avoid becoming pregnant during treatment with olumiant and for at least one week after the last olumiant treatment. you must tell your doctor if you become pregnant as olumiant should not be used during pregnancy. you should not use olumiant while breast-feeding as it is not known if this medicine passes into milk. you and your doctor should decide if you will breast-feed or use olumiant. you should not do both. driving and using machines olumiant has no effect on the ability to drive and use machines.", 'Entity_Recognition': [{'Text': 'olumiant', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 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{'Title': '3. how to take olumiant', 'Section_Content': 'treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis. always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended dose is 4 mg once a day. your doctor may give you a lower dose of 2 mg once a day, particularly if you are over 75 years old or if you have an increased risk of infections. if the medicine is working well, your doctor may decide the dose can be reduced. if you have reduced kidney function, the recommended dose of olumiant is 2 mg once a day. olumiant is for oral use. you should swallow your tablet with a drink of water. you can take the tablets either with or without food. to help you remember to take olumiant, you may find it easier to take it at the same time every day. if you take more olumiant than you should if you take more olumiant than you should, contact your doctor. you may get some of the side effects described in section 4. if you forget to take olumiant - if you miss a dose, take it as soon as you remember. - if you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day. - do not take a double dose to make up for a forgotten tablet. if you stop taking olumiant do not stop taking olumiant unless your doctor tells you to stop taking it. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'olumiant', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 9}, {'Id': 11, 'BeginOffset': 86, 'EndOffset': 106, 'Score': 0.9737057089805603, 'Text': 'rheumatoid arthritis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9705992937088013}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 120, 'EndOffset': 133}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 267, 'EndOffset': 268}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 325, 'EndOffset': 326}, {'Id': 15, 'BeginOffset': 371, 'EndOffset': 373, 'Score': 0.42082443833351135, 'Text': '75', 'Category': 'PROTECTED_HEALTH_INFORMATION', 'Type': 'AGE', 'Traits': []}, {'Id': 12, 'BeginOffset': 420, 'EndOffset': 430, 'Score': 0.9927243590354919, 'Text': 'infections', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9218079447746277}]}, {'Text': 'reduced kidney function', 'Type': 'PROBLEM', 'BeginOffset': 525, 'EndOffset': 548}, {'Id': 5, 'BeginOffset': 574, 'EndOffset': 582, 'Score': 0.675990641117096, 'Text': 'olumiant', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9890611171722412, 'RelationshipScore': 0.9839739203453064, 'RelationshipType': 'DOSAGE', 'Id': 6, 'BeginOffset': 586, 'EndOffset': 590, 'Text': '2 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FREQUENCY', 'Score': 0.9976600408554077, 'RelationshipScore': 0.9956159591674805, 'RelationshipType': 'FREQUENCY', 'Id': 7, 'BeginOffset': 591, 'EndOffset': 601, 'Text': 'once a day', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 586, 'EndOffset': 587}, {'Id': 14, 'BeginOffset': 968, 'EndOffset': 980, 'Score': 0.7718897461891174, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6622681021690369}]}, {'Text': '4.', 'Type': 'NUMBER', 'BeginOffset': 1002, 'EndOffset': 1004}, {'Id': 8, 'BeginOffset': 1027, 'EndOffset': 1035, 'Score': 0.3940797448158264, 'Text': 'olumiant', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 1232, 'EndOffset': 1245}, {'Id': 9, 'BeginOffset': 1300, 'EndOffset': 1308, 'Score': 0.6583691835403442, 'Text': 'olumiant', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.554735004901886}]}, {'Id': 10, 'BeginOffset': 1328, 'EndOffset': 1336, 'Score': 0.7345815896987915, 'Text': 'olumiant', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8033117055892944}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1433, 'EndOffset': 1446}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. infection such as shingles, which may affect up to 1 in 10 people: tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of shingles (herpes zoster): - painful skin rash with blisters and fever very common side effects (may affect more than 1 in 10 people): - throat and nose infections - high levels of blood fat (cholesterol) shown by blood test common side effects (may affect up to 1 in 10 people): - cold sores (herpes simplex) - infection causing a sick stomach or diarrhoea (gastroenteritis) - urinary infection - pneumonia - high number of platelets (cells involved in blood clotting), shown by blood test - feeling sick in the stomach (nausea) - high levels of liver enzymes, shown by blood test - rash 37 uncommon side effects (may affect up to 1 in 100 people): - low number of white bloods cells (neutrophils), shown by blood test - increase in an enzyme called creatine kinase, shown by blood test - high levels of blood fat (triglycerides), shown by blood test - acne - weight gain - swelling of the face - urticaria - blood clots in the blood vessels of the lungs - blood clot in the veins of the legs or pelvis, called a deep vein thrombosis (dvt) reporting of side effects if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'olumiant', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, 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{'Title': '5. how to store olumiant', 'Section_Content': "keep this medicine out of the sight and reach of children. this medicine does not require any special storage conditions. do not use this medicine after the expiry date which is stated on the blister and carton after 'exp'. the expiry date refers to the last day of that month. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.", 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what olumiant contains - the active substance is baricitinib. each tablet contains 2 or 4 milligrams of baricitinib. - the other ingredients are: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, iron oxide red (e172), lecithin (soya) (e322), macrogol, poly (vinyl alcohol), talc and titanium dioxide (e171). what olumiant looks like and contents of the pack olumiant 2 mg film-coated tablets are light pink, oblong tablets, with "lilly" on one side and "2" on the other. olumiant 4 mg film-coated tablets are medium pink, round tablets, with "lilly" on one side and "4" on the other. the tablets are rounded and have hollow sides to help you pick them up. olumiant 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84 and 98 tablets in calendar blisters and 28 x 1 and 84 x 1 tablets in perforated unit dose blisters. not all the pack sizes may be marketed.', 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