Ocaliva
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 
OCALIVA 5 mg film-coated tablets  
 
OCALIVA 10 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
OCALIVA 5 mg film-coated tablets 
Each film-coated tablet contains 5 mg of obeticholic acid. 
 
OCALIVA 10 mg film-coated tablets 
Each film-coated tablet contains 10 mg of obeticholic acid. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet  
 
OCALIVA 5 mg film-coated tablets 
Yellow, 8 mm round tablet debossed with ‘INT’ on one side and ‘5’ on the other side. 
 
OCALIVA 10 mg film-coated tablets 
Yellow, 7.6 mm X 7.4 mm triangular tablet debossed with ‘INT’ on one side and ‘10’ on the other 
side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary 
cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to 
UDCA or as monotherapy in adults unable to tolerate UDCA. 
 
4.2 Posology and method of administration 
 
Posology 
Prior to initiation of treatment with obeticholic acid the patient’s hepatic status must be known. 
The starting dose and dosage titration by PBC patient population is shown in Table 1. 
 



 

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Table 1: Dosage Regimen by PBC Patient Population 
 
Staging/Classification Non-Cirrhotic or  

Child-Pugh Class A 
Child-Pugh Class B or C or 
Decompensated Cirrhotic 

Starting Dosage 
 

5 mg once daily 5 mg once weekly 

Dosage Titration 
 

For patients who have not 
achieved an adequate reduction in 
alkaline phosphatase (ALP) 
and/or total bilirubin after 6 
months of treatment and the 
patient is tolerating obeticholic 
acid, titrate up to 10 mg once 
daily 

For patients who have not achieved 
an adequate reduction in ALP and/or 
total bilirubin after 3 months of 
treatment and the patient is tolerating 
obeticholic acid, titrate up to 5 mg 
twice weekly (at least 3 days apart) 
and subsequently to 10 mg twice 
weekly (at least 3 days apart) based 
on response and tolerability 
 

Maximum Dosage 10 mg once daily 10 mg twice weekly (at least 3 days 
apart) 
 

 
No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid. 
 
Management and dose adjustment for severe pruritus  

Management strategies include the addition of bile acid binding resins or antihistamines.  
 
For patients experiencing severe intolerability due to pruritus, one or more of the following should be 
considered:    
 
For Non-Cirrhotic or Child-Pugh Class A patients: 

• Reducing the dosage of obeticholic acid to: 
▪ 5 mg every other day, for patients intolerant to 5 mg once daily  
▪ 5 mg once daily, for patients intolerant to 10 mg once daily 

• Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a 
reduced dosage.   

• Continue to increase the dosage to 10 mg once daily, as tolerated, to achieve optimal response. 
 

For Child-Pugh Class B or C or Decompensated Cirrhotic patients: 

• Reducing the dosage of obeticholic acid to: 
▪ 5 mg once weekly, for patients intolerant to 5 mg twice weekly  
▪ 10 mg once weekly, for patients intolerant to 10 mg twice weekly 

• Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a 
reduced dosage if applicable.   

• Continue to increase the dosage to 10 mg twice weekly, as tolerated, to achieve optimal 
response. 
 

Consider discontinuing treatment with obeticholic acid for patients who continue to experience 
persistent, intolerable pruritus. 
 

Special populations 

Patients with hepatic impairment 

See table 1 for dose recommendations. Further, see sections 4.4 and 5.2. 
 

Elderly (> 65 years) 

Limited data exists in elderly patients.  No dose adjustment is required for elderly patients (see 
section 5.2). 
 



 

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Patients with renal impairment 
Limited data exists in patients with mild and moderate renal impairment and no data exists in severe 
renal impairment.  No dose adjustment is required for patients with renal impairment (see section 5.2). 
 
Paediatric population 

There is no relevant use of obeticholic acid in the paediatric population in the treatment of primary 
biliary cholangitis (PBC).  
 
Method of administration  
The tablet should be taken orally with or without food. 
 
For patients taking bile acid binding resins, obeticholic acid should be administered at least 4-6 hours 
before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible (see 
section 4.5).   
 
4.3 Contraindications 
 
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.    
- Complete biliary obstruction. 
 
4.4 Special warnings and precautions for use 
 
Liver related adverse events  
Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been 
observed in patients taking obeticholic acid.  Clinical signs and symptoms of hepatic decompensation 
have also been observed.  These events have occurred as early as within the first month of treatment.  
Liver-related adverse events have primarily been observed at doses higher than the maximum 
recommended dose of 10 mg once daily (see section 4.9). In the post marketing setting, serious liver 
injury and death have been reported with more frequent dosing of obeticholic acid than recommended 
in patients with moderate to severe decreases in liver function.  
After initiation of therapy, all patients should be monitored for progression of PBC disease with 
laboratory and clinical assessment to determine whether dosage adjustment is needed. Patients at an 
increased risk of hepatic decompensation, including those with laboratory evidence of worsening liver 
function and /or progression to cirrhosis, should be monitored more closely. Dosing frequency should 
be reduced for patients who progress to advanced disease (i.e. from Child-Pugh Class A to Child-Pugh 
Class B or C) (see sections 4.2 and 5.2).   
 
Severe pruritus 
Severe pruritus was reported in 23% of patients treated with OCALIVA 10 mg arm, 19% of patients in 
the OCALIVA titration arm, and 7% of patients in the placebo arms.  The median time to onset of 
severe pruritus was 11, 158, and 75 days for patients in the OCALIVA 10 mg, OCALIVA titration, 
and placebo arms, respectively.  Management strategies include the addition of bile acid binding resins 
or antihistamines, dose reduction, reduced dosing frequency, and/or temporary dose interruption (see 
sections 4.2 and 4.8).  
 

4.5 Interaction with other medicinal products and other forms of interaction 
 
Medicinal products that are affected by obeticholic acid 
 
Warfarin 

International normalised ratio (INR) is decreased following co-administration of warfarin and 
obeticholic acid.  INR should be monitored and the dose of warfarin adjusted, if needed, to maintain 
the target INR range when co-administering obeticholic acid and warfarin. 
 



 

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Interaction with CYP1A2 substrates with narrow therapeutic index  

Obeticholic acid may increase the exposure to concomitant medicinal products that are CYP1A2 
substrates.  Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. 
theophylline and tizanidine) is recommended. 
 
Medicinal products that affect obeticholic acid 
 
Bile acid binding resins 

Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid 
absorption and may reduce efficacy of obeticholic acid.  When concomitant bile acid binding resins 
are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a 
bile acid binding resin, or at as great an interval as possible.   
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no data on the use of obeticholic acid in pregnant women.  Animal studies do not indicate 
direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).  As a 
precautionary measure, it is preferable to avoid the use of obeticholic acid during pregnancy.  
 
Breast-feeding 
It is unknown whether obeticholic acid is excreted in human milk.  Based on animal studies and 
intended pharmacology, obeticholic acid is not expected to interfere with breast-feeding or the growth 
or development of a breast-fed child.  A decision should be made whether to discontinue 
breast-feeding or to discontinue/abstain from obeticholic acid therapy taking into account the benefit 
of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3). 
 
Fertility 
No fertility data is available in humans.  Animal studies do not indicate any direct or indirect effects 
on fertility or reproduction (see section 5.3). 
 

4.7 Effects on ability to drive and use machines 
 
Obeticholic acid has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%).  Adverse 
reactions leading to discontinuation were 1% in the OCALIVA titration arm and 11% in the 
OCALIVA 10 mg arm.  The most common adverse reaction leading to discontinuation was pruritus.  
The majority of pruritus occurred within the first month of treatment and tended to resolve over time 
with continued dosing. 
 
Tabulated list of adverse reactions 
The adverse reactions reported with OCALIVA in the phase III clinical study are listed in the table 
below by MedDRA system organ class and by frequency.  Frequencies are defined as: very common 
(≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
< 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). 
 
Table 2.  Frequency of adverse reactions in PBC patients* 
 
System Organ Class Very common Common 
Endocrine disorders  Thyroid function abnormality 
Nervous system disorders  Dizziness 
Cardiac disorders  Palpitations 



 

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System Organ Class Very common Common 
Respiratory, thoracic and 
mediastinal disorders 

 Oropharyngeal pain 

Gastrointestinal disorders Abdominal pain and 
discomfort 

Constipation 

Skin and subcutaneous tissue 
disorders  

Pruritus Eczema, Rash 

Musculoskeletal and 
connective tissue disorders 

 Arthralgia 

General disorders and 
administration site conditions 

Fatigue  Oedema peripheral, Pyrexia 

* Adverse reactions are defined as events occurring at a rate of greater than or equal to 5% of patients on 
obeticholic acid treatment arm and at an incidence greater than or equal to 1% higher than in the placebo 
treatment arm. 
 
Description of selected adverse reactions 
 
Pruritus 

Approximately 60% of patients had a history of pruritus upon enrollment in the phase III study.  
Treatment-emergent pruritus generally started within the first month following the initiation of 
treatment.  
 
Relative to patients who started on 10 mg once daily in the OCALIVA 10 mg arm, patients in the 
OCALIVA titration arm had a lower incidence of pruritus (70% and 56% respectively) and a lower 
discontinuation rate due to pruritus (10% and 1%, respectively). 
 
The percentages of patients who required interventions (i.e, dosage adjustments, treatment 
interruptions, or initiation of antihistamines or bile acid binding resins) were 41% in the OCALIVA 
10 mg arm, 34% in the OCALIVA titration group, and 19% in the placebo group. 
 
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 
 
The highest single dose exposure of obeticholic acid in healthy volunteers has been at the 500 mg 
dose. Repeated doses of 250 mg have been administered for 12 consecutive days and some subjects 
experienced pruritus and reversible transaminase liver elevations.  In PBC patients who received 
OCALIVA 25 mg once daily (2.5 times the highest recommended dosage) or 50 mg once daily 
(5 times the highest recommended dosage), a dose-dependent increase in the incidence of liver-related 
adverse reactions (e.g., ascites, primary biliary cholangitis flare, new onset jaundice), and 
transaminase and bilirubin elevations (up to greater than 3-times upper limit of normal [ULN]) were 
reported.  In the case of overdose, patients should be carefully observed and supportive care 
administered, as appropriate. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group:  Bile and liver therapy, Bile acid preparations. ATC code: A05AA04  
 



 

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Mechanism of action 
Obeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear 
receptor expressed at high levels in the liver and intestine.  FXR is thought to be a key regulator of bile 
acid, inflammatory, fibrotic, and metabolic pathways.  FXR activation decreases the intracellular 
hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol, as well as, 
by increasing transport of bile acids out of the hepatocytes.  These mechanisms limit the overall size of 
the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids. 
 
Pharmacodynamic effects 
 
Clinical efficacy and safety 
A phase III, randomised, double-blind, placebo-controlled, parallel-group, 12-month study (POISE) 
evaluated the safety and efficacy of OCALIVA in 216 patients with PBC who were taking UDCA for 
at least 12 months (stable dose for ≥ 3 months) or who were unable to tolerate UDCA and did not 
receive UDCA for ≥3 months.  Patients were included in the trial if the alkaline phosphatase (ALP) 
was greater than or equal to 1.67 times upper limit of normal (ULN) and/or if total bilirubin was 
greater than 1 x ULN but less 2 x ULN.  Patients were randomised (1:1:1) to receive once daily 
placebo, OCALIVA 10 mg, or OCALIVA titration (5 mg titrated to 10 mg at 6 months dependent on 
therapeutic response/tolerability).  The majority (93%) of patients received treatment in combination 
with UDCA and a small number of patients (7%) unable to tolerate UDCA received placebo, 
OCALIVA (10 mg) or OCALIVA titration (5 mg to 10 mg) as monotherapy.  ALP and total bilirubin 
were assessed as categorical variables in the primary composite endpoint, as well as continuous 
variables over time.   
 
The study population was predominantly female (91%) and white (94%).  The mean age was 56 years, 
with the majority of patients less than 65 years old.  Mean baseline ALP values ranged from 316 U/L 
to 327 U/L.  Mean baseline total bilirubin values ranged from 10 μmol/L to 12 μmol/L across 
treatment arms, with 92% of patients within normal range. 
 
Treatment with OCALIVA 10 mg or OCALIVA titration (5 mg to 10 mg) resulted in clinically and 
statistically significant increases (p < 0.0001) relative to placebo in the number of patients achieving 
the primary composite endpoint at all study time points (see Table 3).  Responses occurred as early as 
2 weeks and were dose dependent (OCALIVA 5 mg compared with 10 mg at 6 months, p=0.0358).  
 
 



 

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Table 3. Percentage of PBC patients achieving the primary composite endpointa at month 6 and 
month 12 with or without UDCAb  

 

 
OCALIVA 

10 mgc 
(N = 73) 

OCALIVA 
Titrationc 
(N = 70) 

Placebo 
(N=73) 

Month 6    

Responders, n (%) 
Corresponding 95% CI 

37 (51) 
39%, 62% 

24 (34) 
23%, 45% 

5 (7) 
1%, 13% 

p-valued <0.0001 <0.0001 NA 

Month 12    
Responders, n (%) 
Corresponding 95% CI 

35 (48) 
36%, 60% 

32 (46) 
34%, 58% 

7 (10) 
4%, 19% 

p-valued <0.0001 <0.0001 NA 

Components of primary endpointe 
ALP less than 1.67-times 
ULN, n (%) 40 (55) 33 (47) 12 (16) 

Decrease in ALP of at 
least 15%, n (%) 57 (78) 54 (77) 21 (29) 

Total bilirubin less than or 
equal to 1-times ULNf, n 
(%) 

60 (82) 62 (89) 57 (78) 

a Percentage of subjects achieving a response, defined as an ALP less than 1.67-times the ULN, total bilirubin 
within the normal range, and an ALP decrease of at least 15%.  Missing values were considered a non-response. 
The Fisher’s exact test was used to calculate the 95% Confidence Intervals (Cis). 
b In the trial there were 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients 
(8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA titration arm, and 5 patients (7%) in the 
placebo arm. 
c Patients were randomized (1:1:1) to receive OCALIVA 10 mg once daily for the entire 12 months of the trial, 
or OCALIVA titration (5 mg once daily for the initial 6 months, with the option to increase to 10 mg once daily 
for the last 6 months, if the patient was tolerating OCALIVA but had ALP 1.67-times the ULN or greater, and/or 
total bilirubin above the ULN, or less than 15% ALP reduction) or placebo.   
dOCALIVA titration and OCALIVA 10 mg versus placebo.  P-values are obtained using the 
Cochran-Mantel-Haenszel General Association test stratified by intolerance to UDCA and pretreatment ALP 
greater than 3-times ULN and/or AST greater than 2-times ULN and/or total bilirubin greater than ULN. 
e Response rates were calculated based on the observed case analysis (i.e., [n=observed responder]/[N=Intention 
to Treat (ITT) population]); percentage of patients with Month 12 values are 86%, 91% and 96% for the 
OCALIVA 10 mg, OCALIVA titration and placebo arms, respectively. 
f The mean baseline total bilirubin value was 0.65 mg/dL, and was within the normal range (i.e., less than or 
equal to the ULN) in 92% of the enrolled patients. 
 
Mean reduction in ALP 
Mean reductions in ALP were observed as early as Week 2 and were maintained through Month 12 for 
patients who were maintained on the same dosage throughout 12 months.  For patients in the 
OCALIVA titration arm whose OCALIVA dosage was increased from 5 mg once daily to 10 mg once 
daily, additional reductions in ALP were observed at Month 12 in the majority of patients. 
 

Mean reduction in gamma-glutamyl transferase (GGT) 

The mean (95% CI) reduction in GGT was 178 (137, 219) U/L in the OCALIVA 10 mg arm, 138 
(102, 174) U/L in the OCALIVA titration arm, and 8 (-48, 32) U/L in the placebo arm. 
 
Monotherapy 

Fifty-one PBC patients with baseline ALP 1.67-times ULN or greater and/or total bilirubin greater 
than ULN were evaluated for a biochemical response to OCALIVA as monotherapy (24 patients 



 

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received OCALIVA 10 mg once daily and 27 patients received placebo) in a pooled analysis of data 
from the phase III randomised, double-blind, placebo-controlled 12 month study (POISE) and from a 
randomised, double-blind, placebo-controlled, 3- month study.  At month 3, 9 (38%) 
OCALIVA-treated patients achieved a response to the composite endpoint, compared to 1 (4%) 
placebo-treated patient.  The mean (95% CI) reduction in ALP in OCALIVA-treated patients was 246 
(165, 327) U/L compared to an increase of 17 (-7, 42) U/L in the placebo-treated patients. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
obeticholic acid in all subsets of the paediatric population in PBC (see section 4.2 for information on 
paediatric use). 
 
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme.  This 
means that further evidence on this medicinal product is awaited.  The European Medicines Agency 
will review any new information which may become available at least every year and this SmPC will 
be updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Obeticholic acid is absorbed with peak plasma concentrations (Cmax) occurring at a median time (tmax) 
of approximately 2 hours.  Co-administration with food does not alter the extent of absorption of 
obeticholic acid.  
 
Distribution 
Human plasma protein binding of obeticholic acid and its conjugates is greater than 99%.  The volume 
of distribution of obeticholic acid is 618 L.  The volume of distributions of glyco- and 
tauro-obeticholic acid has not been determined.  
 
Biotransformation 
Obeticholic acid is conjugated with glycine or taurine in the liver and secreted into bile.  These glycine 
and taurine conjugates of obeticholic acid are absorbed in the small intestine leading to enterohepatic 
recirculation.  The conjugates can be deconjugated in the ileum and colon by intestinal microbiota, 
leading to the conversion to obeticholic acid that can be reabsorbed or excreted in faeces, the principal 
route of elimination. 
 
After daily administration of obeticholic acid, there was accumulation of the glycine and taurine 
conjugates of obeticholic acid which have in vitro pharmacological activities similar to the parent 
drug.  The metabolite-to -parent ratios of the glycine and taurine conjugates of obeticholic acid were 
13.8 and 12.3, respectively, after daily administration.  An additional third obeticholic acid metabolite, 
3-glucuronide is formed but is considered to have minimal pharmacologic activity. 
 
Elimination 
After administration of radiolabeled obeticholic acid, greater than 87% is excreted in faeces.  Urinary 
excretion is less than 3%. 
 
Dose/Time proportionality 
Following multiple-dose administration of 5, 10, and 25 mg once daily for 14 days, systemic 
exposures of obeticholic acid increase dose proportionally.  Exposures of glyco- and tauro-obeticholic 
acid, and total obeticholic acid increase more than proportionally with dose. 
 

Special populations 
Elderly 

There are limited pharmacokinetic data in elderly patients (≥ 65 years).  Population pharmacokinetic 
analysis, developed using data from patients up to 65 years old, indicated that age is not expected to 
significantly influence obeticholic acid clearance from the circulation. 
 



 

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Paediatric population 

No pharmacokinetic studies were performed with obeticholic acid in patients less than 18 years of age. 
 
Gender 

Population pharmacokinetic analysis indicated that gender does not influence obeticholic acid 
pharmacokinetics. 
 

Race 

Population pharmacokinetic analysis indicated that race is not expected to influence obeticholic acid 
pharmacokinetics. 
 
Renal impairment 

Obeticholic acid has minimal renal elimination with less than 3% of the dose recovered in urine.  
Based on population pharmacokinetic analysis, renal function did not have a meaningful effect on  
the pharmacokinetics of obeticholic acid.   
 

Hepatic impairment 

Obeticholic acid is metabolised in the liver and intestines.  The systemic exposure of obeticholic acid, 
its active conjugates, and endogenous bile acids is increased in patients with moderate and severe 
hepatic impairment (Child-Pugh Class B and C, respectively) when compared to healthy controls.  
Therefore, a modified dose regimen for patients with moderate or severe hepatic impairment is 
required to achieve plasma exposure levels similar to patients with no hepatic impairment (see section 
4.2). 
 
The impact of mild hepatic impairment (Child-Pugh Class A) on the pharmacokinetics of obeticholic 
acid was negligible, therefore, no dose adjustment is necessary for patients with mild hepatic 
impairment. 
 
In subjects with mild, moderate and severe hepatic impairment (Child-Pugh Class A, B, and C, 
respectively), mean AUC of total obeticholic acid, the sum of obeticholic acid and its two active 
conjugates, increased by 1.13-, 4- and 17-fold, respectively, compared to subjects with normal hepatic 
function following single-dose administration of 10 mg obeticholic acid. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, 
reproduction and development.   
 
Oral administration of obeticholic acid above the NOAEL to mice, rats, and dogs in pivotal, repeat 
dose toxicity studies resulted primarily in effects on the hepatobiliary system.  These included 
increased liver weights, alterations in serum chemistry parameters (ALT, AST, LDH, ALP, GGT, 
and/or bilirubin), and macroscopic/microscopic alterations.  All changes were reversible with 
discontinued dosing, and are consistent with and predict the dose-limiting toxicity in humans 
(systemic exposure at NOAEL was up to 24-fold higher than that seen at the maximum recommended 
human dose).  In a pre- and post-natal toxicity study in rats, the tauro-conjugate of obeticholic acid 
was found in pups nursing from dams dosed with obeticholic acid 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 

Tablet core 
Microcrystalline cellulose (E460) 
Sodium starch glycolate (Type A) 
Magnesium stearate 



 

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Tablet coating 
Poly(vinyl alcohol), partially hydrolysed (E1203) 
Titanium dioxide (E171) 
Macrogol 3350 (E1521) 
Talc (E553b) 
Iron oxide yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
4 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an 
aluminium foil induction seal. 
 
Pack size:  30 or 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Intercept Pharma International Ltd. 
Ormond Building  
31 – 36 Ormond Quay Upper 
Dublin 7  
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1139/001 
 
EU/1/16/1139/002 
 
EU/1/16/1139/003 
 
EU/1/16/1139/004 
 
 



 

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 12/12/2016 
Date of latest renewal: 12 December 2018 
 
 
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. 
 
  



 

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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 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION 

MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION 

 



 

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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 

Almac Pharma Services (Ireland) Limited 
Finnabair Industrial Estate, 
Dundalk, 
Co.Louth, 
A91 P9KD, 
Ireland 
 
Almac Pharma Services  
Seagoe Industrial Estate 
Portadown 
Craigavon 
BT63 5UA 
United Kingdom 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
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 



 

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as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION 
 
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 
726/2004, the MAH shall complete, within the stated timeframe, the following measures: 

Description Due date 

Interventional study 747-302:  

Description:  In order to confirm the efficacy and safety of OCALIVA, the MAH 
should conduct and submit the results of study 747-302, a confirmatory double-
blind, randomised, placebo-controlled multicentre study investigating the clinical 
benefit associated with OCALIVA treatment in patients with PBC who are either 
unresponsive or intolerant to UDCA treatment based on clinical endpoints. 

Rationale: to investigate the effect of obeticholic acid on clinical outcomes in 
subjects with PBC 

Final report: 2023 
 

Interventional study 747-401:  

Description: In order to confirm the efficacy and safety of OCALIVA, the MAH 
should conduct and submit the results of study 747-401, a double-blind, randomised, 
placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of 
OCALIVA in patients with PBC and moderate to severe hepatic impairment.    

Rationale: to investigate the uncertainties related to the lack of data in a population 
with more advanced liver disease 

Final report: 2020 

 

 

 

 
  



 

16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 

17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



 

18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 5 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
OCALIVA 5 mg film-coated tablets  
obeticholic acid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg of obeticholic acid.  
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 

19 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Intercept Pharma International Ltd. 
31–36 Ormond Quay Upper  
Dublin 7  
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1139/001 30 film-coated tablets 
EU/1/16/1139/003 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 

 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
OCALIVA 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
  



 

20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 10 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
OCALIVA 10 mg film-coated tablets  
obeticholic acid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg of obeticholic acid. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 

21 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Intercept Pharma International Ltd. 
31–36 Ormond Quay Upper 
Dublin 7  
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1139/002 30 film-coated tablets 
EU/1/16/1139/004 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
OCALIVA 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number}  
NN: {number}  



 

22 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE 5 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
OCALIVA 5 mg film-coated tablets  
obeticholic acid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg of obeticholic acid. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 

23 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Intercept Pharma International Ltd. 
31–36 Ormond Quay Upper  
Dublin 7  
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1139/001 30 film-coated tablets 
EU/1/16/1139/003 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 

 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
  



 

24 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE 10 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
OCALIVA 10 mg film-coated tablets  
obeticholic acid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains10 mg of obeticholic acid.  
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 

25 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Intercept Pharma International Ltd. 
31–36 Ormond Quay Upper  
Dublin 7  
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1139/002 30 film-coated tablets 
EU/1/16/1139/004 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



 

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

27 

Package leaflet: Information for the patient 
 

OCALIVA 5 mg film-coated tablets 
OCALIVA 10 mg film-coated tablets 

 
obeticholic acid 

 
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, 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, pharmacist or nurse.  This includes any possible 

side effects not listed in this leaflet.  See section 4. 
 
What is in this leaflet 
 
1. What OCALIVA is and what it is used for 
2. What you need to know before you take OCALIVA 
3. How to take OCALIVA 
4. Possible side effects  
5. How to store OCALIVA 
6. Contents of the pack and other information 
 
 
1. What OCALIVA is and what it is used for 
 
OCALIVA contains the active substance obeticholic acid (farnesoid X-receptor agonist) which helps 
to improve how your liver works by reducing the production and build up of bile in the liver and also 
reducing inflammation.  
 
This medicine is used to treat adult patients with a type of liver disease known as primary biliary 
cholangitis (also known as primary biliary cirrhosis), either by itself or together with another 
medicine, ursodeoxycholic acid. 
 
 
2. What you need to know before you take OCALIVA  
 

Do not take OCALIVA: 
- if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in 

section 6). 
- if you have a complete blockage of the biliary tract (liver, gall bladder and bile ducts). 
 
Warnings and precautions  
Talk to your doctor or pharmacist before taking OCALIVA. 
 
If you experience itching that is difficult to tolerate, talk to your doctor. 
 
Your doctor will do blood tests to monitor the health of your liver when you start treatment and 
regularly from there on.   
 



 

28 

Children and adolescents 
This medicine is not for use in children or adolescents. 
 
Other medicines and OCALIVA 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, tell your doctor if you are taking so-called bile acid binding resins (cholestyramine, 
colestipol, colesevelam) used to lower blood cholesterol levels as they may lessen the effect of 
OCALIVA.  If you take any of these medicines, take OCALIVA at least 4-6 hours before or 4-6 hours 
after taking bile acid binding resin, giving as much time as possible.   
 
The levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a 
medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored 
by your doctor while taking OCALIVA.  Your doctor may need to monitor how well your blood clots 
when taking medicines such as warfarin (a medicine to help your blood flow) with OCALIVA.  
 
Pregnancy and breast-feeding 
There is little information about the effects of OCALIVA in pregnancy.  As a precautionary measure, 
you should not take OCALIVA if you are pregnant. 
 
It is not known if this medicine passes into human milk.  Your doctor will determine whether you 
should discontinue breast-feeding or discontinue/abstain from OCALIVA therapy taking into account 
the benefit of breast-feeding for the child and the benefit of therapy for you.  
 
Driving and using machines 
This medicine has no or negligible influence on your ability to drive or use machines. 
 
 
3. How to take OCALIVA 
 
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 one 5 mg film-coated tablet once daily by mouth. 
Your doctor may adjust your dose depending on your liver function or if you experience itching that is 
difficult to tolerate. 
 
Depending on your body’s response after 6 months your doctor may increase your dose to 10 mg once 
daily.  Your doctor will discuss any change of dose with you. 
 
You can take OCALIVA with or without food.  If you take bile acid binding resins, take this medicine 
at least 4-6 hours before or at least 4-6 hours after the bile acid binding resin (see section "Other 
medicines and OCALIVA"). 
 
If you take more OCALIVA than you should 
If you accidentally take too many tablets, you may experience liver related side effects such as 
yellowing of the skin.  Contact a doctor or go to a hospital for advice immediately.   
 
If you forget to take OCALIVA 
Skip the missed dose and take your next dose when you would normally take it.  Do not take a double 
dose to make up for a forgotten tablet. 
 
If you stop taking OCALIVA 
You should continue to take OCALIVA for as long as your doctor tells you to.  Do not stop taking the 
medicine without talking to your doctor first. 
 



 

29 

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. 
 
Tell your doctor or pharmacist if you experience itching of the skin (pruritus) or if the itch gets worse 
while on this medicine.  In general itching of the skin is a very common side effect that begins within 
the first month following the start of treatment with OCALIVA and usually becomes less severe over 
time.. 
 
Very common side effects (may affect more than 1 in 10 people): 
• stomach pain 
• feeling tired 
 
Common side effects (may affect up to 1 in 10 people): 
• thyroid hormone irregularity 
• dizziness 
• fast or irregular heart beat (palpitations) 
• pain in the mouth and throat 
• constipation 
• dry skin, redness of the skin (eczema) 
• rash 
• pain in your joints 
• swelling in the hands and feet 
• fever 
 
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 OCALIVA 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.  
The expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions.  
 
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 OCALIVA contains  
The active substance is obeticholic acid.  

OCALIVA 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic 
acid. 

OCALIVA 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of obeticholic 
acid. 

 



 

30 

• The other ingredients are: 
- Tablet core: Microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium 

stearate. 
- Film-coat: Polyvinyl alcohol, part hydrolysed (E1203), titanium dioxide (E171), 

macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172). 
 
What OCALIVA looks like and contents of the pack 
- OCALIVA 5 mg is a yellow, round film-coated tablet with ‘INT’ on one side and ‘5’ on  
         the other side of the film-coated tablet. 
- OCALIVA 10 mg is a yellow, triangular film-coated tablet with ‘INT’ on one side and ‘10’ on  
         the other side of the film-coated tablet.  
 
Pack sizes 
1 bottle with 30 or 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Intercept Pharma International Ltd. 
Ormond Building  
31 – 36 Ormond Quay Upper  
Dublin 7  
Ireland 
 
Manufacturer 
Almac Pharma Services (Ireland) Limited 
Finnabair Industrial Estate, 
Dundalk, 
Co.Louth, 
A91 P9KD, 
Ireland 
 
Almac Pharma Services  
Seagoe Industrial Estate 
Portadown 
Craigavon 
BT63 5UA 
United Kingdom 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Intercept Pharma Nederland B.V., 
Netherland/Pays-Bas/Niederlande  
Tél/Tel: +32 (0) 24037219 
 

Lietuva 
AOP Orphan Pharmaceuticals AG 
Tel.: +370 672 12222 
 

България 
AOP Orphan Pharmaceuticals AG 
Teл: +35 988 6666096 
 

Luxembourg/Luxemburg 
Intercept Pharma Nederland B.V., 
Pays-Bas/Niederlande  
Tél/Tel.: +352 27861461 
 

Česká republika 
AOP Orphan Pharmaceuticals AG 
Tel.: +420 251 512 947 
 

Magyarország 
AOP Orphan Pharmaceuticals AG 
Tel.: +36 1 3192633 
 



 

31 

Danmark 
AOP Orphan Pharmaceuticals AG 
Østrig 
Tlf: +43 1 5037244 
 

Malta 
Intercept Pharma International Ltd. 
Irlanda 
Tel: +353 144 75 196 
 

Deutschland 
Intercept Pharma Deutschland GmbH 
Tel: +49 30 30 80 767 5 
 

Nederland 
Intercept Pharma Nederland B.V.,  
Netherland 
Tel: +31 207 139 216 
 

Eesti 
AOP Orphan Pharmaceuticals AG 
Leedu 
Tel: +370 672 12222 
 

Norge 
AOP Orphan Pharmaceuticals AG 
Østerrike 
Tlf: +43 1 5037244 
 

Ελλάδα 
Intercept Pharma International Ltd. 
Ιρλανδία 
Τηλ: +353 144 75 196 
 

Österreich 
Intercept Pharma Austria GmbH 
Tel: +43 1928 4012 

España 
Intercept Pharma Spain S.L.U. 
Tel: +34 914 194 970 
 

Polska 
AOP Orphan Pharmaceuticals AG 
Tel: +48 22 322 76 80 
 

France 
Intercept Pharma France SAS 
Tél: +33 176 701 049 
 

Portugal 
Intercept Pharma Portugal, Unipessoal Lda 
Tel: +351 308 805 674 
 

Hrvatska 
AOP Orphan Pharmaceuticals AG 
Austrija 
Tel: +43 1 5037244 
 

România 
AOP Orphan Pharmaceuticals AG 
Tel: +40 722 660744 
 

Ireland 
Intercept Pharma International Ltd. 
Ireland 
Tel: +353 144 75 196 
 

Slovenija 
AOP Orphan Pharmaceuticals AG 
Avstrija 
Tel: +43 1 5037244 
 

Ísland 
AOP Orphan Pharmaceuticals AG 
Austurríki 
Tlf: +43 1 5037244 
 

Slovenská republika 
AOP Orphan Pharmaceuticals AG 
Tel: +421 2 45523126 
 

Italia 
Intercept Italia S.r.l. 
Tel: +39 0236026571 

Suomi/Finland 
AOP Orphan Pharmaceuticals AG 
Itävalta 
Tlf: +43 1 5037244 
 

Κύπρος 
Intercept Pharma International Ltd. 
Ιρλανδία 
Τηλ: +353 144 75 196 
 

Sverige 
AOP Orphan Pharmaceuticals AG 
Österrike 
Tlf: +43 1 5037244 
 
 



 

32 

Latvija 
AOP Orphan Pharmaceuticals AG 
Lietuva 
Tel: +370 672 12222 
 

United Kingdom 
Intercept Pharma UK & Ireland Ltd. 
Tel: + 44 330 100 3694 
 

 
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>. 
 
This medicine has been given ‘conditional approval’.  This means that there is more evidence to come 
about this medicine. 
 
The European Medicines Agency will review new information on this medicine at least every year and 
this leaflet will be updated as necessary. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  There are also links to other websites about rare diseases and treatments.  
 
 
 
 


	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 MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take ocaliva', 'Section_Content': 'do not take ocaliva: - if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in section 6). - if you have a complete blockage of the biliary tract (liver, gall bladder and bile ducts). warnings and precautions talk to your doctor or pharmacist before taking ocaliva. if you experience itching that is difficult to tolerate, talk to your doctor. your doctor will do blood tests to monitor the health of your liver when you start treatment and regularly from there on. children and adolescents this medicine is not for use in children or adolescents. other medicines and ocaliva tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. in particular, tell your doctor if you are taking so-called bile acid binding resins (cholestyramine, colestipol, colesevelam) used to lower blood cholesterol levels as they may lessen the effect of ocaliva. if you take any of these medicines, take ocaliva at least 4-6 hours before or 4-6 hours after taking bile acid binding resin, giving as much time as possible. the levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored by your doctor while taking ocaliva. your doctor may need to monitor how well your blood clots when taking medicines such as warfarin (a medicine to help your blood flow) with ocaliva. pregnancy and breast-feeding there is little information about the effects of ocaliva in pregnancy. as a precautionary measure, you should not take ocaliva if you are pregnant. it is not known if this medicine passes into human milk. your doctor will determine whether you should discontinue breast-feeding or discontinue/abstain from ocaliva therapy taking into account the benefit of breast-feeding for the child and the benefit of 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'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a medicine', 'Type': 'TREATMENT', 'BeginOffset': 1429, 'EndOffset': 1439}, {'Text': 'your blood flow', 'Type': 'TEST', 'BeginOffset': 1448, 'EndOffset': 1463}, {'Id': 22, 'BeginOffset': 1470, 'EndOffset': 1477, 'Score': 0.7449219226837158, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 31, 'BeginOffset': 1479, 'EndOffset': 1488, 'Score': 0.9683977365493774, 'Text': 'pregnancy', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.943381130695343}]}, {'Text': 'ocaliva in pregnancy', 'Type': 'PROBLEM', 'BeginOffset': 1557, 'EndOffset': 1577}, {'Id': 24, 'BeginOffset': 1627, 'EndOffset': 1634, 'Score': 0.827235221862793, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5998569130897522}]}, {'Id': 33, 'BeginOffset': 1646, 'EndOffset': 1654, 'Score': 0.9943487048149109, 'Text': 'pregnant', 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{'Title': '3. how to take ocaliva', 'Section_Content': '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 one 5 mg film-coated tablet once daily by mouth. your doctor may adjust your dose depending on your liver function or if you experience itching that is difficult to tolerate. depending on your body\'s response after 6 months your doctor may increase your dose to 10 mg once daily. your doctor will discuss any change of dose with you. you can take ocaliva with or without food. if you take bile acid binding resins, take this medicine at least 4-6 hours before or at least 4-6 hours after the bile acid binding resin (see section "other medicines and ocaliva"). if you take more ocaliva than you should if you accidentally take too many tablets, you may experience liver related side effects such as yellowing of the skin. contact a doctor or go to a hospital for advice immediately. if you forget to take ocaliva skip the missed dose and take your next dose when you would normally take it. do not take a double dose to make up for a forgotten tablet. if you stop taking ocaliva you should continue to take ocaliva for as long as your doctor tells you to. do not stop taking the medicine without talking to your doctor first. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'ocaliva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '5', 'Type': 'NUMBER', 'BeginOffset': 163, 'EndOffset': 164}, {'Id': 6, 'BeginOffset': 173, 'EndOffset': 186, 'Score': 0.28906792402267456, 'Text': 'coated tablet', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.7140898108482361, 'RelationshipScore': 0.8826095461845398, 'RelationshipType': 'STRENGTH', 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'EndOffset': 264, 'Score': 0.9678205847740173, 'Text': 'liver', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 19, 'BeginOffset': 295, 'EndOffset': 302, 'Score': 0.9953870177268982, 'Text': 'itching', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6811602711677551}, {'Name': 'DIAGNOSIS', 'Score': 0.5078588724136353}]}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 374, 'EndOffset': 375}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 421, 'EndOffset': 423}, {'Id': 11, 'BeginOffset': 506, 'EndOffset': 513, 'Score': 0.8280893564224243, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'bile acid binding resins', 'Type': 'TREATMENT', 'BeginOffset': 548, 'EndOffset': 572}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 579, 'EndOffset': 592}, {'Id': 24, 'BeginOffset': 602, 'EndOffset': 605, 'Score': 0.5388988256454468, 'Text': '4-6', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_MEDICATION_NAME', 'Traits': [], 'Attributes': [{'Type': 'GENERIC_NAME', 'Score': 0.7986453175544739, 'RelationshipScore': 0.5364372730255127, 'RelationshipType': 'OVERLAP', 'Id': 12, 'BeginOffset': 548, 'EndOffset': 557, 'Text': 'bile acid', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 25, 'BeginOffset': 631, 'EndOffset': 634, 'Score': 0.5988923907279968, 'Text': '4-6', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_MEDICATION_NAME', 'Traits': [], 'Attributes': [{'Type': 'GENERIC_NAME', 'Score': 0.7986453175544739, 'RelationshipScore': 0.5113749504089355, 'RelationshipType': 'OVERLAP', 'Id': 12, 'BeginOffset': 548, 'EndOffset': 557, 'Text': 'bile acid', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'the bile acid binding resin', 'Type': 'TREATMENT', 'BeginOffset': 647, 'EndOffset': 674}, {'Id': 14, 'BeginOffset': 709, 'EndOffset': 716, 'Score': 0.7993432879447937, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 15, 'BeginOffset': 737, 'EndOffset': 744, 'Score': 0.8441683650016785, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'liver related side effects', 'Type': 'PROBLEM', 'BeginOffset': 823, 'EndOffset': 849}, {'Id': 21, 'BeginOffset': 858, 'EndOffset': 879, 'Score': 0.5125750303268433, 'Text': 'yellowing of the skin', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.4564398527145386}]}, {'Id': 16, 'BeginOffset': 964, 'EndOffset': 971, 'Score': 0.299547016620636, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 1062, 'EndOffset': 1075}, {'Id': 17, 'BeginOffset': 1130, 'EndOffset': 1137, 'Score': 0.7509422302246094, 'Text': 'ocaliva', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5317885279655457}]}, {'Id': 18, 'BeginOffset': 1166, 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. tell your doctor or pharmacist if you experience itching of the skin (pruritus) or if the itch gets worse while on this medicine. in general itching of the skin is a very common side effect that begins within the first month following the start of treatment with ocaliva and usually becomes less severe over time.. very common side effects (may affect more than 1 in 10 people): stomach pain feeling tired common side effects (may affect up to 1 in 10 people): thyroid hormone irregularity dizziness fast or irregular heart beat (palpitations) pain in the mouth and throat constipation dry skin, redness of the skin (eczema) rash pain in your joints swelling in the hands and feet fever 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': 'ocaliva', '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}, {'Id': 14, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.964383602142334, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7659466862678528}]}, {'Id': 15, 'BeginOffset': 141, 'EndOffset': 148, 'Score': 0.9754005074501038, 'Text': 'itching', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9560180306434631}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.9973264932632446, 'RelationshipScore': 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707}, {'Text': 'eczema)', 'Type': 'PROBLEM', 'BeginOffset': 709, 'EndOffset': 716}, {'Text': 'rash pain', 'Type': 'PROBLEM', 'BeginOffset': 717, 'EndOffset': 726}, {'Text': 'your joints swelling in the hands and feet fever', 'Type': 'PROBLEM', 'BeginOffset': 730, 'EndOffset': 778}, {'Id': 39, 'BeginOffset': 792, 'EndOffset': 804, 'Score': 0.6877800822257996, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8393254280090332}]}, {'Id': 40, 'BeginOffset': 820, 'EndOffset': 832, 'Score': 0.8719419240951538, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8196956515312195}]}, {'Id': 41, 'BeginOffset': 903, 'EndOffset': 915, 'Score': 0.9483481645584106, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7022961974143982}]}, {'Id': 42, 'BeginOffset': 964, 'EndOffset': 976, 'Score': 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{'Title': '5. how to store ocaliva', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton and bottle after "exp". the expiry date refers to the last day of that month. this medicinal product does not require any special storage conditions. 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 ocaliva contains the active substance is obeticholic acid. ocaliva 5 mg film-coated tablets: each film-coated tablet contains 5 mg of obeticholic acid. ocaliva 10 mg film-coated tablets: each film-coated tablet contains 10 mg of obeticholic acid. the other ingredients are: - tablet core: microcrystalline cellulose (e460), sodium starch glycolate (type a), magnesium stearate. - film-coat: polyvinyl alcohol, part hydrolysed (e1203), titanium dioxide (e171), macrogol 3350 (e1521), talc (e553b), iron oxide yellow (e172). what ocaliva looks like and contents of the pack - ocaliva 5 mg is a yellow, round film-coated tablet with 'int' on one side and '5' on the other side of the film-coated tablet. - ocaliva 10 mg is a yellow, triangular film-coated tablet with 'int' on one side and '10' on the other side of the film-coated tablet. pack sizes 1 bottle with 30 or 100 film-coated tablets. not all pack sizes may 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