Hepcludex
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 
 
HEPCLUDEX 2 mg powder for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains bulevirtide acetate equivalent to 2 mg bulevirtide. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for solution for injection (powder for injection). 
 
The powder is white to off-white. 
After reconstitution, solution with a pH of approximately 9.0 and osmolality of approximately 
300 mOsm/kg. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or 
serum) HDV-RNA positive adult patients with compensated liver disease. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated only by a physician experienced in the treatment of patients with HDV 
infection.  
 
Posology 
 
Bulevirtide should be administered at 2 mg once daily (every 24 h ± 4 h) by subcutaneous injection as 
monotherapy or in co-administration with a nucleoside/nucleotide analogue for treatment of underlying 
HBV infection. 
 
Concerning co-administration with the nucleoside-nucleotide analogues for treatment of HBV infection, 
refer to section 4.4. 
 
Duration of treatment 
The optimal treatment duration is unknown. Treatment should be continued as long as associated with 
clinical benefit. 
 
Consideration to discontinue the treatment should be given in case of sustained (6 months) HBsAg 
seroconversion or loss of virological and biochemical response.  
 
Missed doses 
If an injection has been omitted and less than 4 hours have elapsed since the scheduled time, the injection 
must be performed as soon as possible. The time of the next injection will not be calculated from the 
time of the "rescue" injection, but according to the injection schedule previously established. It is, 



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therefore, necessary to return to the usual pattern of administration, at the appointed time, the following 
day. 
 
If an injection has been missed and more than 4 hours have elapsed since the scheduled time, the missed 
dose should not be administered. 
 
The next injection will take place according to the usual schedule (injection of the prescribed dose 
without doubling), at the appointed time the next day. 
 
If the injection has been made by mistake more than 4 hours after the scheduled time, the next 
administration must take place in the usual way (i.e. in accordance with the original schedule). 
 
Special populations 
 
Elderly population  
No data is available in patients >65 years. 
 
Renal impairment 
No studies have been conducted with bulevirtide in patients with renal impairment.  
Renal function should be carefully monitored. Elevation of bile salts may occur during treatment. Due 
to renal excretion of bile salts, elevation of bile salts may be greater in patients with renal impairment. 
 
Hepatic impairment 
No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh-Turcotte class 
A). The safety and efficacy of bulevirtide in patients with decompensated cirrhosis have not been 
established (see sections 4.4 and 5.2). 
 
Paediatric population 
The safety and efficacy of bulevirtide in patients younger than 18 years of age have not been established. 
No data is available. 
 
Method of administration  
 
For subcutaneous use only. Bulevirtide may be injected into sites such as the upper thigh, or abdomen. 
 
Appropriate training should be given to the patients self-administering the product to minimise the risk 
of the injection site reactions.  
 
The “Instructions for the User”, provided in the carton, must be followed carefully by the patient.  
 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
 
4.4 Special warnings and precautions for use 
 
HDV and HBV genotype 
 
HDV genotype 1 was predominant in the clinical trials population. It is not known whether HDV or 
HBV genotype affects the clinical efficacy of bulevirtide.   
 
Decompensated liver disease 
 



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The pharmacokinetics, safety and efficacy of bulevirtide in patients with decompensated cirrhosis has 
not been established. The use in patients with decompensated liver disease is not recommended. 
 
Co-infection with hepatitis B virus (HBV) 
 
The underlying HBV infection should be simultaneously managed according to current treatment 
guidelines. In the clinical study of bulevirtide MYR202, only patients with signs of active hepatitis 
despite nucleoside/nucleotide analogue treatment were included; tenofovir disoproxil fumarate was co-
administered with bulevirtide. Close monitoring of HBV-DNA levels is recommended. 
 
Hepatitis exacerbations after treatment cessation 
 
Discontinuation of treatment with bulevirtide can lead to reactivation of the HDV and HBV infection 
and exacerbation of hepatitis. In case of treatment discontinuation, careful monitoring of liver function 
including transaminase levels, as well as HBV DNA and HDV RNA viral load should be performed. 

 
Increase of bile salts 
 
Asymptomatic and dose-dependent elevation of serum bile salts has been very commonly observed with 
bulevirtide. This increase is reversible upon discontinuation of treatment. It can be expected in the 
majority of patients taking into account the mechanism of action of bulevirtide which, by inactivating 
the NTCP (sodium taurocholate co-transporter polypeptide) receptor, blocks the transport of bile acids 
from portal blood to hepatocytes. In patients with renal insufficiency, the increase in bile salts may be 
more pronounced. 
 
There are no data available on the long-term impact (> 48 weeks) of this bile salt increase induced by 
bulevirtide (see section 4.8). 
 
Administration site reactions 
Bulevirtide is intended for subcutaneous injection which is associated with risks for injection site 
reactions such as swelling, redness, irritation, itchiness, infection, hematoma and local pain. These local 
reactions are more likely to appear if the injection is accidentally misplaced or the solution accidentally 
misdirected to the soft tissue.  
 
Co-infection with human immunodeficiency virus and hepatitis C virus: 
 
No data are available from HIV or HCV co-infected patients.  
 
Excipients: 
 
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially "sodium-free". 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium-
taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products 
(e.g. sulfasalazin, irbesartan, ezetimibe, ritonavir, and ciclosporin A) is not recommended. 
 
As a precautionary measure, close clinical monitoring is warranted when NTCP substrates (e.g. estrone-
3-sulfate, fluvastatin, atorvastatin, pitavastatin, pravastatin, rosuvastatin, and thyroid hormones) are co-
administered with bulevirtide. When possible, co-administration of these substrates should be avoided. 
 
In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a 
concentration ≥ 0.5 µM, which is only reached in vivo after administration of high bulevirtide doses (10 
mg subcutaneous). The clinical relevance of these findings is unknown. As a precautionary measure, 
close clinical monitoring is warranted when OATP1B1/3 substrates (e.g. atorvastatin, bosentan, 



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docetaxel, fexofenadine, glecaprevir, glyburide (glibenclamide), grazoprevir, nateglinide, paclitaxel, 
paritaprevir, pitavastatin, pravastatin, repaglinide, rosuvastatin, simeprevir, simvastatin, olmesartan, 
telmisartan, valsartan, voxilaprevir) are co-administered. When possible, co-administration of these 
substrates should be avoided. 
 
In a clinical study in healthy subjects, co-administration of tenofovir and bulevirtide revealed no impact 
on tenofovir pharmacokinetic. 
 
No CYP inhibition by bulevirtide was observed in vitro at clinically relevant concentrations. However, 
in a clinical study, an approximately 40% increase in geometric mean of partial AUC2-4h values of co-
administered midazolam (CYP3A4 substrate) was observed in combination of high dose bulevirtide (10 
mg) and tenofovir (245 mg), whereas no significant influence on midazolam AUC2-4h was detected for 
tenofovir alone. As a precautionary measure, close clinical monitoring is warranted for co-administered 
narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates (e.g. cyclosporine, 
carbamazepine, simvastatin, sirolimus, and tacrolimus).  
 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of bulevirtide in pregnant women.  
 
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. 
  
As a precautious measure, it is preferable to avoid the use of bulevirtide during pregnancy and in women 
of child-bearing age who do not use contraception. 
 
Breastfeeding 
 
It is unknown whether bulevirtide is excreted in human breast milk. Therefore, a decision must be made 
whether to discontinue breastfeeding or to discontinue / abstain from treatment with bulevirtide, taking 
into account the benefit of breastfeeding for the child with regard to the benefit of treatment for the 
mother. 
 
Fertility 
 
No human data on the effect of bulevirtide on fertility are available. In animal studies, no effects of 
bulevirtide on male or female mating and fertility were noted. 
 
4.7 Effects on ability to drive and use machines 
 
The product has minor influence on the ability to drive and use machines. Patients should be informed 
that dizziness has been reported during treatment with bulevirtide. (see section 4.8). 
 
4.8 Undesirable effects 
 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were asymptomatic, dose dependent and reversible (after 
discontinuation of treatment) increase in bile salts (very common) and injection site reactions (common) 
(see section 4.4).  
 
The most frequently reported serious adverse reaction was an exacerbation of hepatitis after 
discontinuation of bulevirtide, possibly related to virologic rebound after discontinuation of treatment 
(see section 4.4). 



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Tabulated list of adverse reactions 
 
Common and very common adverse reactions are listed below by system organ class and absolute 
frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10). 
 

Med DRA System Organ Class Adverse reactions 
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) 

Blood and lymphatic system 
disorders 

 Anaemia 
Eosinophilia  
Leukopenia 
Lymphopenia  
Neutropenia 
Reticulocytopenia 
Thrombocytopenia 

Nervous system disorders  Dizziness  
Headache 
Somnolence 

Cardiac disorders  Tachycardia 
Gastrointestinal disorders  Abdominal distention  

Nausea 
Skin and subcutaneous tissue 
disorders 

 Erythema 
Hyperhidrosis 
Pruritus 
Rash 

Musculoskeletal and connective 
tissue disorders 

 Arthralgia  
Muscle spasms 

Renal and urinary disorders   Haematuria 
General disorders and 
administration site conditions 

 Fatigue 
Influenza like illness 
Injection site erythema 
Injection site haematoma 
Injection site pruritus 
Injection site dermatitis 
Local reaction 

Investigations Total bile salt increased ALT increased 
Amylase increased  
AST increased 
Blood bilirubin increased 
Blood creatinine increased 
GGT increased 
Haemoglobin decreased 
INR increased 
Lipase increased 
Neutrophil count decreased 

 
 
Description of selected adverse reactions: 

ALT elevations 

Most ALT elevations were reported after treatment cessation and may be related to hepatitis 
exacerbation after withdrawal of antiviral treatment.  

Reporting of suspected adverse reactions 
 



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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 
 
There are no data on human overdose with bulevirtide. If overdose occurs, the patient must be monitored 
for evidence of toxicity and given standard supportive treatment as necessary. 
  
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antivirals for systemic use, other antivirals. ATC code:  J05AX28 
 
Mechanism of action 
 
Bulevirtide blocks the entry of HBV and HDV into hepatocytes by binding to and inactivating NTCP, 
a bile salt liver transporter serving as essential HBV/HDV entry receptor. 
 
Clinical efficacy and safety 
 
The clinical efficacy and safety of bulevirtide was investigated in two Phase 2 studies. Patients with 
chronic HDV infection and active hepatitis were included. The population of both studies was mainly 
Caucasian, HDV genotype 1 was predominant. 
 
MYR 202 study 
A multicentre, open-label, randomised phase 2 clinical study evaluated the efficacy and safety of three 
doses of bulevirtide (2 mg/day, 5 mg/day and 10 mg/day) for 24 weeks in patients with chronic hepatitis 
D with liver cirrhosis, or who failed previous interferon therapy, or for whom such therapy was 
contraindicated (including history of interferon intolerance). Study participants received either daily 
subcutaneous injections of bulevirtide 2 mg/day, 5 mg/day and 10 mg/day on top of tenofovir (tablets), 
or tenofovir alone for 24 weeks. 50% of the study participants had liver cirrhosis at baseline. Participants 
had compensated liver disease, mean age was 40.2 (9.5) years, 66.9% were male, 85.6% were 
Caucasians, 13.6% Asians and 0.8% Black. Patients had active hepatitis with mean levels ALT of 115 
(79.5) U/L. Patients with HIV and active HCV infection were excluded. Baseline characteristics were 
comparable between treatment arms. The primary endpoint of the study was undetectable HDV RNA 
or decrease by ≥2log10 from baseline to week 24.  
 
 
The table below summarises the efficacy results in mITT population at week 24: 

HDV RNA response  Arm A:  
(n=28) 
2mg 
bulevirtide + 
TDF 

Arm B: 
(n=32) 
5mg 
bulevirtide + 
TDF 

Arm C:  
(n=30) 
10mg 
bulevirtide + 
TDF 

Arm 
D: 
 (n=28) 
TDF 

Patients with undetectable 
HDV RNA or decrease by 
≥2log10 from baseline to 
week 24,  

53.6 %* 50.0% * 76.7%* 3.6% 

Patients with undetectable 
HDV RNA or decline by 21.4%* 28.1% * 36.7% * 0.0% 

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


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>2log10 and normal ALT at 
week 24 

Patients with ALT 
normalisation 42.9%* 50.0%* 40.0%* 7.1% 

*p-value ≤ 0.05 TDF=tenofovir disoproxil fumarate 
ALT values ≤31 U/L for female and ≤41 U/L for male were considered normal 
 
In this study, 25 participants developed anti-drug antibodies (ADA). No evidence of these ADA on the 
pharmacokinetics nor on the efficacy of Hepcludex was observed.  
 
MYR 203 study 
In study 203, a total of 15 patients were treated with bulevirtide 2 mg daily for 48 weeks. In this limited 
dataset, the efficacy and safety profiles were not substantially different than for patients treated for 24 
weeks. Two subjects developed virological breakthrough, possibly related to medication non-adherence.  
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Hepcludex in one or more subsets of the paediatric population for the treatment of chronic hepatitis D 
infection (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 new information on this medicinal product at least every 
year and this SmPC will be updated as necessary. 
 
 
  



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5.2 Pharmacokinetic properties 
 
The pharmacokinetic properties of bulevirtide were characterised after intravenous and subcutaneous 
administration. The exposure of bulevirtide increased disproportionally while the clearance and volume 
of distribution decreased with higher doses.  
 
Distribution 
 
The estimated volume of distribution is smaller than total body water. In vitro plasma protein binding 
is high with >99% of bulevirtide bound to plasma proteins.  
 
Biotransformation 
 
No biotransformation study was performed for bulevirtide. Bulevirtide is a linear peptide consisting of 
L-amino acids, and it is expected to be degraded to smaller peptides and individual amino acids. No 
active metabolites are expected. 
 
Based on the results of in vitro interaction studies, bulevirtide did not inhibit CYP1A2, CYP2A6, 
CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.  

No in vitro induction of CYP1A2, CYP2B6 or CYP3A4 by bulevirtide was observed.   

Based on the in vitro studies, no clinically relevant interaction is expected for most common efflux 
transporters (MDR1, BCRP, BSEP, MATE1 and MATE2K) and uptake transporters (OATP2B1, 
OAT1, OAT3, OCT1 and OCT2). A specific in vitro interaction was identified with the organic anion 
transporting polypeptides, OATP1B1 and OATP1B3 with IC50 values of 0.5 and 8.7µM, respectively.  
 
Elimination 
No bulevirtide excretion into urine was detected in healthy volunteers. Elimination via target (NTCP) 
binding is assumed to be the main route. Both distribution and elimination after multiple dosing were 
reduced compared to values estimated after the first dose. Accumulation ratios for 2 mg dose for Cmax 
and AUC were approximately 2-fold. Steady state is assumed to be achieved within the first weeks of 
administration. After reaching peak concentrations, plasma levels declined with t1/2 of 4-7 hours. 
 
 
Renal impairment 
No studies have been conducted with bulevirtide in patients with renal impairment.  
 
Hepatic impairment 
No studies have been conducted with bulevirtide in patients with moderate and severe hepatic 
impairment. 
 
Elderly 
No data is available in patients older than 65 years of age. 
 
Paediatric population 
No data is available in patients younger than 18 years of age.  
 
 
 
 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, single and repeated dose toxicity, and toxicity to reproduction and development. 
 



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No genotoxicity and carcinogenicity studies were conducted due to the nature and mechanism of action 
of the product. 
 
A pre- and post-natal development study (PPND) has been completed in rats and did not show any 
bulevirtide-related toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium carbonate anhydrous 
Sodium hydrogen carbonate 
Mannitol 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products, except those mentioned in 
section 6.6.  
 
6.3 Shelf life 
 
1 year. 
 
Before reconstitution, the product can be stored in a refrigerator (2°C -8°C) for up to three months.  
 
After reconstitution, chemical and physical in-use stability has been demonstrated for 2 hours at room 
temperature (up to 25°C). From a microbiological point of view, it is recommended that the product 
should be used immediately.  
 
6.4 Special precautions for storage 
 
Store in a freezer (-20 °C). In order to protect from light, keep the vials in the outer carton. Store up to 
three months in a refrigerator (2°C -8°C) (see section 6.3)  and do not freeze again. 
 
6.5 Nature and contents of container 
 
Colourless glass vial with bromobutyl rubber stopper, sealed with a flip off cap (aluminium with plastic 
disc) 
 
Pack-size of 30 vials. 
 
6.6 Special precautions for disposal and other handling 
 
Each vial is intended for single use only and the excess of unused product must be properly disposed 
of. Water for injections, syringes, needle tips and alcohol wipes should be provided to the patient.  
 
 
 
Instructions for use 
 
The bulevirtide vial should be taken from the refrigerator shortly before the injection and the blue flip-
off cap has to be removed. A single-use syringe should be taken and a needle tip (25 mm, 25G) be 
attached to the syringe head in order to extract 1 ml of water for injection into the syringe. The syringe 
needle with the syringe containing the water for injection should then be inserted into the bulevirtide 



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vial through the rubber stopper. The water of injection inside the syringe will then be injected into the 
bulevirtide vial and the bulevirtide vial has to be carefully swayed until a clear solution is obtained. The 
complete content of the bulevirtide vial has to be extracted back into the same syringe with the 25 mm, 
25 G needle tip.   
The needle tip has then to be detached from the needle. To this syringe, a special injection needle tip 
(13 mm, 26 or 27G) has to be attached and any remaining air bubbles have to be removed from the 
syringe prior injection. The content of the bulevirtide vial will then by administered subcutaneously.  
 
Disposal of medicinal product and auxiliary components 
 
All used components/ waste should be handled according to the current regulation. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
7. MARKETING AUTHORISATION HOLDER 
 
Myr GmbH 
Hessenring 89 
61348 Bad Homburg/Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1446/001 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
 
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 and on the website of MYR GmbH (http://myr-pharma.com/). 
 
 
  

http://www.ema.europa.eu/
http://myr-pharma.com/


12 

 
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 responsible for batch release 
 
 Lyocontract GmbH 
Pulverwiese 1 
38871 Ilsenburg 
Germany  
 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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 (MAH) shall submit the first PSUR 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 marketing authorisation holder (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. 

 
 
 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION 
 
This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 
726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 
 

Description Due date 
Data collection from participation in the MYR-HDV registry - 



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Description Due date 
MYR204 - A Multicentre, Open-label, Randomized Phase 2b Clinical Study to 
Assess Efficacy and Safety of Bulevirtide in Combination with Pegylated 
Interferon alfa-2a in Patients with Chronic Hepatitis Delta 

28 February 
2023  
 

MYR301 - A Multicentre, Open-label, Randomized Phase 3 Clinical Study to 
Assess Efficacy and Safety of Bulevirtide in Patients with Chronic Hepatitis 
Delta  

28 February 
2025 

  



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



17 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
HEPCLUDEX 2 mg powder for solution for injection 
bulevirtide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 2 mg bulevirtide (as acetate).  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium carbonate anhydrous, sodium hydrogen carbonate, mannitol, hydrochloric acid, 
and sodium hydroxide. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection 
30 single-use vials  
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use after reconstitution. 
Read the package leaflet before 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 
 
Store in a freezer. In order to protect from light, keep the vials in the outer carton. Store up to three 
months in a refrigerator and do not freeze again. 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
MYR GmbH 
Hessenring 89 
61348 Bad Homburg v. d. H. 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1446/001 
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
HEPCLUDEX  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
HEPCLUDEX 2 mg powder for injection 
bulevirtide 
Subcutaneous use after reconstitution 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 mg 
 
6. OTHER 
 
Store in a refrigerator for up to three months 
 
 
 
 
 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



21 

Package leaflet: Information for the patient 
 

 
Hepcludex 2 mg powder for solution for injection 

bulevirtide 
 

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 using 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 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 nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 

1. What Hepcludex is and what it is used for 
2. What you need to know before you take Hepcludex 
3. How to take Hepcludex 
4. Possible side effects 
5. How to store Hepcludex 
6. Contents of the pack and other information 
7. Step-by-step injection guide  
 

1. What Hepcludex is and what it is used for 
 
What Hepcludex is 
Hepcludex contains the active substance bulevirtide, which is an antiviral medicine. 
 
What Hepcludex is used for 
Hepcludex is used to treat long-term (chronic) hepatitis delta virus (HDV) infection in adults with 
compensated liver disease (when the liver is still working well enough). Infection with hepatitis delta 
virus causes inflammation of the liver. 
  
How Hepcludex works 
HDV uses a particular protein in liver cells to enter the cells. Bulevirtide, the active substance in this 
medicine blocks the protein and so prevents the HDV from getting into liver cells. This reduces the 
spread of HDV in the liver and reduces inflammation.  
 
 
2. What you need to know before you take Hepcludex 
 

Do not take Hepcludex: 
- if you are allergic to bulevirtide or any of the other ingredients of this medicine (listed in section 

6). 
 
If you are not sure, speak to your doctor before taking this medicine. 
 
 
Warnings and precautions  
Do not stop your treatment with Hepcludex unless your doctor advises you to do so. Stopping the 
treatment can reactivate the infection and worsen your disease. 



22 

 
Talk to your doctor or pharmacist before taking Hepcludex:  
 

• if your liver is not working well enough – it is not known how well Hepcludex works in these 
circumstances; if your liver is not functioning well, taking Hepcludex is not recommended. 
 

• if you have had kidney disease or if tests have shown problems with your kidneys. Before and 
during treatment, your doctor may order blood tests to check how well your kidneys are 
working; 

 
• if you have HIV infection or hepatitis C - it is not known how well Hepcludex works in these 

circumstances; your doctor may order blood tests to check the status of your HIV or hepatitis C 
infection 

 
• if you get reactions such as swelling, redness, irritation, bruising, itchiness, infection or pain at 

the injection site – this medicine is given by injection under the skin. 
 
• if you have an elevation of bile acids in the blood. Hepcludex increases the level of bile acids in 

the blood – the long-term effect of bile acid elevation is not known.  
 
Children and adolescents 
Children and adolescents under 18 years of age should not be treated with Hepcludex. 
 
Other medicines and Hepcludex 
Please tell your doctor if you are taking, have recently taken, or might take any other medicines. 
 
Some medicines can increase side effects of Hepcludex and you should not take them at the same time. 
This is why you should tell your doctor if you are taking any of these medicines:  
 

• ciclosporin, a medicine that supresses the immune system; 
• ezetimibe, used for treating high blood cholesterol; 
• irbesartan, used for treating high blood pressure and heart disease; 
• ritonavir, used to treat HIV infection; 
• sulfasalazine, (used for treating rheumatoid arthritis, ulcerative colitis, and Crohn's disease. 

 
Some medicines can increase or decrease the effects of Hepcludex when taken together. In some cases, 
you may need to have certain tests or your doctor may change the dose or monitor you regularly: 

• cancer treatments (e.g. dasatinib, docetaxel, ibrutinib, paclitaxel); 
• antihistamine medicines used for allergies (e.g. ebastine, fexofenadine); 
• immune system medicines (e.g. everolimus, sirolimus, tacrolimus); 
• medicines for hepatitis C and HIV treatment (e.g. darunavir, glecaprevir, grazoprevir, indinavir, 

maraviroc, paritaprevir, saquinavir, simeprevir, tipranavir, voxilaprevir); 
• medicines for diabetes (e.g. glibenclamide, nateglinide, repaglinide); 
• medicines for erectile dysfunction (e.g., avanafil, sildenafil, vardenafil); 
• medicines for treating high blood pressure and heart disease (e.g. olmesartan, telmisartan, 

valsartan); 
• statin, medicines used for high blood cholesterol (e.g. atorvastatin, fluvastatin, lovastatin, 

pitavastatin, pravastatin, rosuvastatin, simvastatin); 
• thyroid hormones used to treat thyroid problems; 
• alfentanil, an opioid medicine used to treat severe pain; 
• bosentan, used for pulmonary arterial hypertension; 
• buspirone, an anxiety medicine; 
• budesonide, used for asthma and chronic obstructive pulmonary disease; 
• conivaptan and tolvaptan, used to treat hyponatraemia (low sodium levels); 
• darifenacin, used to treat urinary incontinence; 



23 

• dronedarone, heart medicine for cardiac arrhythmias; 
• eletriptan, used for migraine headaches; 
• eplerenone, used for high blood pressure; 
• estrone-3-sulfate a menopausal hormone medicine; 
• felodipine and nisoldipine (heart medicines); 
• lomitapide, used for high blood cholesterol; 
• lurasidone and quetiapine, antipsychotic medicines for psychiatric disorders; 
• midazolam and triazolam, medicines to treat insomnia (inability to sleep) and for anaesthesia 

(to avoid pain during surgery); 
• naloxegol, used to treat dependence on opioid medicines for severe pain;  
• ticagrelor, anticoagulant to prevent blood clotting. 

 
Pregnancy, breastfeeding and fertility 
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your 
doctor for advice before taking this medicine. You should not use this medicine unless specifically told 
to by your doctor. 
 
If you are a woman of childbearing potential, you should not take this medicine without using an 
effective method of contraception.  
 
Talk to your doctor to decide whether you should breastfeed while taking Hepcludex.  
It is not known whether Hepcludex can pass into breast milk. Therefore, a decision must be made 
whether to discontinue breastfeeding or to discontinue Hepcludex. 
 
Driving and using machines 
Dizziness and tiredness are side effects which may impair your ability to drive and use machines. If you 
have any concerns consult your doctor. 
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially "sodium-
free". 
 
 
3. How to take Hepcludex 
 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
 
Dosage 
The recommended dose is 2 mg once daily by subcutaneous injection (just under the skin). Your doctor 
will say how long you need to take the medicine for. 
 
Your doctor and nurse will show you how to prepare and inject Hepcludex. This package leaflet contains 
a step-by-step injection guide to help you inject the medicine (see Section 7). 
 
If you take more Hepcludex than you should 
The usual dose is 2 mg (1 vial) per day. If you think you may have taken more than you should, tell your 
doctor immediately.  
 
If you forget to take Hepcludex 
If less than 4 hours have passed since your missed dose of Hepcludex, take the missing dose as soon as 
possible and take your next scheduled dose at the usual time.  
 



24 

If more than 4 hours have passed since your missed dose of Hepcludex, do not take the missed dose. 
Take the next dose the following day at the usual time. Do not take a double dose to make up for the 
missed dose. Tell your doctor if you have missed a dose of Hepcludex.  
 
Do not stop taking Hepcludex without speaking with your doctor 
If you do not want to take Hepcludex anymore, talk to your doctor before stopping the treatment. 
Stopping the treatment can reactivate the infection and worsen your disease. Tell your doctor 
immediately about any changes in symptoms after stopping treatment. 
 
If you have any further questions on the use of Hepcludex, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Please tell your doctor if any of the side effects occur, or if you notice any side effects not listed in this 
leaflet.  
 
The following side effect is very common (this may affect more than 1 in 10 people): 

• an increase in the level of bile acids in the blood.  
 
The following side effects are common (these may affect up to 1 in 10 people): 

• headache  
• dizziness  
• nausea 
• tiredness 
• sleepiness 
• faster than normal heartbeat (tachycardia) 
• flu-like illness 
• swollen abdomen (belly) 
• itching  
• joint pain 
• muscle spasms  
• reactions at the injection site that may include swelling, redness, irritation, bruising, 

itchiness, infection or pain 
• excessive or uncontrolled sweating 
• blood in urine 
• redness of the skin 
• rash.  

 
 

Blood tests may also show: 
• an increase in liver enzyme levels and bilirubin in the blood. These are usually raised in 

most diseases that cause damage to the liver;  
• a decrease in red blood cells (anaemia); 
• a reduction in immature red blood cells (reticulocytes); 
• a reduction in white blood cells (eosinophils, lymphocytes, neutrophils), or platelets 

(thrombocytes) in the blood; 
• a reduction in the level of haemoglobin in the blood ; 
• an increase in the level of amylase and lipase in the blood (signs of possible pancreas 

damage); 
• an increase of the international normalised ratio (INR) for blood clotting (which increases 

the risk of bleeding and bruising); 
• An increase in the level of creatinine in the blood (a sign of kidney damage). 



25 

 
 
Reporting of side effects 
If you get any side effects, talk to your doctor 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 to provide more information on the safety of this 
medicine. 
 
 
5. How to store Hepcludex 
 

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 vial after EXP. The 
expiry date refers to the last day of that month. 
 
Store in a freezer (-20 °C). In order to protect from light, keep the vials in the outer carton. Store up to 
three months in a refrigerator (2°C -8°C)and do not freeze again. 
 
The reconstituted solution should be used immediately. However, if this is not possible it can be stored 
for up to 2 hours at a temperature of up to 25°C. 
 
Do not throw away any medicines or used needles via wastewater or household waste. Ask your 
pharmacist how to safely dispose medicines and used needles.  
 
 
 
6. Contents of the pack and other information 
 
What Hepcludex contains 
The active substance is bulevirtide 2 mg. Each vial contains bulevirtide acetate equivalent to 2 mg 
bulevirtide. 
 
The other ingredients are: sodium carbonate anhydrous, sodium hydrogen carbonate, mannitol, 
hydrochloric acid, sodium hydroxide. 
 
 
What Hepcludex looks like and contents of the pack 
Bulevirtide is a powder for solution for injection and comes as a white to off-white powder. 
Each carton contains 30 single doses.  
 
Marketing Authorisation Holder 
MYR GmbH 
Hessenring 89 
61348 Bad Homburg 
Germany 
 
Manufacturer 
LYOCONTRACT GmbH  
Pulverwiese 1  
38871 Ilsenburg  
Germany 
 
  

This leaflet was last revised in <{MM/YYYY}><{month YYYY}>. 
 



26 

 
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<, and on the website of {name of Member State Agency (link)}>. <There 
are also links to other websites about rare diseases and treatments.>  
 
 
<------------------------------------------------------------------------------------------------------------------------> 
 
<The following information is intended for healthcare professionals only:> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  



27 

7. Step-by-step injection guide  
 
Before using Hepcludex, you must first read Sections 1 – 6 of this package leaflet. 
 
Before you begin treatment with this medicine at home, your doctor or nurse will show you how to 
prepare and inject Hepcludex. This guide shows how to inject the medicine yourself. Speak with your 
doctor or nurse if you are unclear about anything or you have questions or need more information or 
help. Take your time to carefully prepare and inject Hepcludex.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
  

Injection sites 

In order to reduce injection site reactions, 
you may change the site of bulevirtide 
injection regularly. 
Do not inject bulevirtide into  the 
following areas: knee, groin, the lower  or 
inner buttocks, directly  over a blood 
vessel, around  the navel (belly button), on 
scar  tissue, a bruise, a mole, a  surgical 
scar, tattoo or burn  site, or where there is 
an  injection site reaction. 

1A 
Storage 

Reconstituted 
bulevirtide must be 
used immediately. 
The following 
instructions are   
for dissolving a 
single dose. 

1B 
Mixing doses 

Bulevirtide vials 
must be stored in 
the original 
packaging in the 
refrigerator (2–
8 ° C) in order to 
protect bulevirtide 
from light. The vials 
can be stored for not 
more than 3 months. 

1C 
Wash hands 

Wash your hands 
well using soap and 
warm water and dry  
them with a clean 
towel. 
Once your hands are 
clean,   
do not touch 
anything else other 
than the medicine,  
supplies and the 
area around the 
injection site. 

1D 
Clean vial 

 
Wipe the vial top 
with a new alcohol 
pad and let the top   
air-dry. 
If you touch the 
rubber top- after 
cleaning it, clean  
it again with a new 
alcohol pad. 

Abdomen Upper thighs 



28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

  
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
  

2A 
Draw up sterile water 

2B 
Inject water into the 
powder 

2C 
Gently mix bulevirtide 

Pick up the syringe. Put the longer needle on.  
 
Important! Be sure the capped needle is tight by 
pushing it down slightly while twisting it 
clockwise. 
 
Pull off the plastic cap. 
 
Open the water for injection. Insert the needle in the 
vial and gently turn the water vial upside down. 
Make sure the tip of the needle is always below the 
surface of the water to help keep air bubbles from 
entering the syringe. 
  
Slowly pull the plunger back to get 1.0 cc/ml of 
sterile water into the syringe. Carefully remove the 
needle and syringe from the vial. 

Gently tap the 
bulevirtide vial to loosen 
the powder. 
Insert the needle with 
sterile water into the 
bulevirtide vial at an 
angle. 
Inject the sterile water 
slowly, so it can drip 
down the side   
of the vial into the 
bulevirtide powder. 

Gently tap the 
bulevirtide vial with 
your fingertip for 10 sec 
to start dissolving the 
powder.  Then gently 
roll the bulevirtide vial 
between your hands to 
ensure thorough 
mixing. Make sure no 
bulevirtide powder is 
stuck to the vial wall. 
Important! Do not 
shake the bulevirtide 
vial. Shaking will make 
the medicine foam   
and it will take much 
longer to dissolve. 

2D 
Inspect bulevirtide 

2E 
Bulevirtide ready for injection 

Once the powder starts 
to dissolve, just set it 
aside and it completely 
will dissolve. 
After tapping, it could 
take up to 3 min to 
dissolve.  

When mixed completely, the bulevirtide solution should be clear. 
Important! Completely dissolved bulevirtide should be clear and without foam. 
If the bulevirtide solution appears foamy or yellowish, allow more time for it to 
dissolve. 
If you see bubbles, gently tap the vial until they disappear. 
If you see any particles in   
the bulevirtide solution once it is (completely) dissolved, do not   
use that vial. Contact your doctor or pharmacist that provided it. 



29 

 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  

3A 
Insert needle into vial 
 

3B 
Draw up bulevirtide 
 

3C 
Finishing preparation 

3D Change and 
discard the needle 

Pick up the syringe. 
 
Insert the needle into the 
vial of liquid 
bulevirtide. 

Gently turn the vial 
upside down. Make 
sure the tip of   
the needle is always 
below the surface of the 
bulevirtide solution to 
help keep air bubbles 
from entering the 
syringe. Slowly pull the 
plunger to get  
1.0 cc/ml of bulevirtide. 

Gently tap or flick the 
syringe and push/pull 
the plunger to remove 
extra air and bubbles. To 
be sure you end 
up with 1.0 cc/ml of 
bulevirtide in the 
syringe, you may need   
to pull the plunger past 
the 
1.0 cc/ml mark. 
Carefully remove the 
needle and syringe from 
the vial. 

Remove the longer 
needle from the syringe 
and dispose of it 
properly so that nobody 
can be injured. 
Important! Do not put 
the plastic cap back on 
the needle. 

3E  
Attach needle for 
injection 
 

3F  
Choose the injection 
site 

3G 
Prepare injection site 

3H 
Inject bulevirtide 

Place the shorter needle 
on the syringe.  
 
Important! Be sure the 
capped needle is tight by 
pushing it down slightly 
while twisting it 
clockwise. 
 
Pull off the plastic cap. 

Choose a site different 
from the one you used 
for your last injection. 
Clean the injection site 
with a new alcohol pad. 
Start in the center, apply 
pressure and clean in a 
circular motion, 
working outward.  
 
Important! Allow site 
to air-dry.  
 
Prepare bulevirtide vial. 
Clean the bulevirtide 
vial top again, using a 
new alcohol pad.  
Allow it to air-dry.  
 

Pinch and hold a fold 
of skin around the 
injection site. 

Pierce the skin at a 45-
degree angle. The 
needle should be 
inserted most of the way 
in. 
 
Slowly push the plunger 
all  
the way to inject 
bulevirtide. 
Remove the needle from 
skin. 
 
Remove the needle from 
the syringe and dispose 
of both properly so that 
nobody can be injured 
(see 3D). 
 



30 

 
 
 
 
 
 
 
 
 
 
 

Annex IV 

Conclusions on the granting of the conditional marketing authorisation presented by the 
European Medicines Agency 

 

 



31 

Conclusions presented by the European Medicines Agency on: 

• Conditional marketing authorisation 

The CHMP having considered the application is of the opinion that the risk-benefit balance is 
favourable to recommend the granting of the conditional marketing authorisation as further 
explained in the European Public Assessment Report. 

 
  


	ANNEX I
	SUMMARY OF PRODUCT CHARACTERISTICS
	For the full list of excipients, see section 6.1.
	4.1 Therapeutic indications
	4.2 Posology and method of administration
	4.5 Interaction with other medicinal products and other forms of interaction
	4.6 Fertility, pregnancy and lactation
	4.7 Effects on ability to drive and use machines
	4.8 Undesirable effects
	4.9 Overdose
	5.1  Pharmacodynamic properties
	Pharmacotherapeutic group: antivirals for systemic use, other antivirals. ATC code:  J05AX28
	5.2 Pharmacokinetic properties
	5.3 Preclinical safety data
	6.1 List of excipients
	6.2 Incompatibilities
	6.3 Shelf life
	6.4 Special precautions for storage
	6.5 Nature and contents of container
	6.6 Special precautions for disposal and other handling
	ANNEX II
	Name and address of the manufacturer responsible for batch release
	ANNEX III
	LABELLING AND PACKAGE LEAFLET
	A. LABELLING
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	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
	9. SPECIAL STORAGE CONDITIONS
	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
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
	2. METHOD OF ADMINISTRATION
	3. EXPIRY DATE
	4. BATCH NUMBER
	5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
	6. OTHER
	B. PACKAGE LEAFLET
	Package leaflet: Information for the patient
	Hepcludex 2 mg powder for solution for injection
	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 using this medicine because it contains important information for you.
	Do not take Hepcludex:
	Warnings and precautions
	Other medicines and Hepcludex
	Pregnancy, breastfeeding and fertility
	Driving and using machines
	Dizziness and tiredness are side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.
	Sodium content
	If you take more Hepcludex than you should
	If you forget to take Hepcludex
	Do not stop taking Hepcludex without speaking with your doctor
	Reporting of side effects
	What Hepcludex contains
	What Hepcludex looks like and contents of the pack
	Bulevirtide is a powder for solution for injection and comes as a white to off-white powder.
	Each carton contains 30 single doses.
	This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
	7. Step-by-step injection guide
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{'Title': '2. what you need to know before you take hepcludex', 'Section_Content': 'do not take hepcludex: - if you are allergic to bulevirtide or any of the other ingredients of this medicine (listed in section 6). if you are not sure, speak to your doctor before taking this medicine. warnings and precautions do not stop your treatment with hepcludex unless your doctor advises you to do so. stopping the treatment can reactivate the infection and worsen your disease. talk to your doctor or pharmacist before taking hepcludex: if your liver is not working well enough it is not known how well hepcludex works in these circumstances; if your liver is not functioning well, taking hepcludex is not recommended. if you have had kidney disease or if tests have shown problems with your kidneys. before and during treatment, your doctor may order blood tests to check how well your kidneys are working; if you have hiv infection or hepatitis c - it is not known how well hepcludex works in these circumstances; your doctor may order blood tests to check the status of your hiv or hepatitis c infection if you get reactions such as swelling, redness, irritation, bruising, itchiness, infection or pain at the injection site this medicine is given by injection under the skin. if you have an elevation of bile acids in the blood. hepcludex increases the level of bile acids in the blood the long-term effect of bile acid elevation is not known. children and adolescents children and adolescents under 18 years of age should not be treated with hepcludex. other medicines and hepcludex please tell your doctor if you are taking, have recently taken, or might take any other medicines. some medicines can increase side effects of hepcludex and you should not take them at the same time. this is why you should tell your doctor if you are taking any of these medicines: ciclosporin, a medicine that supresses the immune system; ezetimibe, used for treating high blood cholesterol; irbesartan, used for treating high blood pressure and heart disease; ritonavir, used to treat hiv infection; sulfasalazine, (used for treating rheumatoid arthritis, ulcerative colitis, and crohn\'s disease. some medicines can increase or decrease the effects of hepcludex when taken together. in some cases, you may need to have certain tests or your doctor may change the dose or monitor you regularly: cancer treatments (e.g. dasatinib, docetaxel, ibrutinib, paclitaxel); antihistamine medicines used for allergies (e.g. ebastine, fexofenadine); immune system medicines (e.g. everolimus, sirolimus, tacrolimus); medicines for hepatitis c and hiv treatment (e.g. darunavir, glecaprevir, grazoprevir, indinavir, maraviroc, paritaprevir, saquinavir, simeprevir, tipranavir, voxilaprevir); medicines for diabetes (e.g. glibenclamide, nateglinide, repaglinide); medicines for erectile dysfunction (e.g., avanafil, sildenafil, vardenafil); medicines for treating high blood pressure and heart disease (e.g. olmesartan, telmisartan, valsartan); statin, medicines used for high blood cholesterol (e.g. atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin); thyroid hormones used to treat thyroid problems; alfentanil, an opioid medicine used to treat severe pain; bosentan, used for pulmonary arterial hypertension; buspirone, an anxiety medicine; budesonide, used for asthma and chronic obstructive pulmonary disease; conivaptan and tolvaptan, used to treat hyponatraemia (low sodium levels); darifenacin, used to treat urinary incontinence; 23 dronedarone, heart medicine for cardiac arrhythmias; eletriptan, used for migraine headaches; eplerenone, used for high blood pressure; estrone-3-sulfate a menopausal hormone medicine; felodipine and nisoldipine (heart medicines); lomitapide, used for high blood cholesterol; lurasidone and quetiapine, antipsychotic medicines for psychiatric disorders; midazolam and triazolam, medicines to treat insomnia (inability to sleep) and for anaesthesia (to avoid pain during surgery); naloxegol, used to treat dependence on opioid medicines for severe pain; ticagrelor, anticoagulant to prevent blood clotting. pregnancy, breastfeeding and fertility if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. you should not use this medicine unless specifically told to by your doctor. if you are a woman of childbearing potential, you should not take this medicine without using an effective method of contraception. talk to your doctor to decide whether you should breastfeed while taking hepcludex. it is not known whether hepcludex can pass into breast milk. therefore, a decision must be made whether to discontinue breastfeeding or to discontinue hepcludex. driving and using machines dizziness and tiredness are side effects which may impair your ability to drive and use machines. if you have any concerns consult your doctor. sodium 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{'Title': '3. how to take hepcludex', 'Section_Content': 'always take this medicine exactly as your doctor has told you. check with your doctor if you are not sure. dosage the recommended dose is 2 mg once daily by subcutaneous injection (just under the skin). your doctor will say how long you need to take the medicine for. your doctor and nurse will show you how to prepare and inject hepcludex. this package leaflet contains a step-by-step injection guide to help you inject the medicine (see section 7). if you take more hepcludex than you should the usual dose is 2 mg (1 vial) per day. if you think you may have taken more than you should, tell your doctor immediately. if you forget to take hepcludex if less than 4 hours have passed since your missed dose of hepcludex, take the missing dose as soon as possible and take your next scheduled dose at the usual time. if more than 4 hours have passed since your missed dose of hepcludex, do not take the missed dose. take the next dose the following day at the usual time. do not take a double dose to make up for the missed dose. tell your doctor if you have missed a dose of hepcludex. do not stop taking hepcludex without speaking with your doctor if you do not want to take hepcludex anymore, talk to your doctor before stopping the treatment. stopping the treatment can reactivate the infection and worsen your disease. tell your doctor immediately about any changes in symptoms after stopping treatment. if you have any further questions on the use of hepcludex, ask your doctor or nurse.', 'Entity_Recognition': [{'Text': 'hepcludex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 138, 'EndOffset': 139}, {'Id': 0, 'BeginOffset': 196, 'EndOffset': 200, 'Score': 0.9464465975761414, 'Text': 'skin', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 512, 'EndOffset': 513}, {'Id': 7, 'BeginOffset': 641, 'EndOffset': 650, 'Score': 0.49138596653938293, 'Text': 'hepcludex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 664, 'EndOffset': 665}, {'Id': 8, 'BeginOffset': 710, 'EndOffset': 719, 'Score': 0.43410739302635193, 'Text': 'hepcludex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 829, 'EndOffset': 830}, {'Id': 9, 'BeginOffset': 875, 'EndOffset': 884, 'Score': 0.4782772362232208, 'Text': 'hepcludex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 983, 'EndOffset': 996}, {'Id': 10, 'BeginOffset': 1075, 'EndOffset': 1084, 'Score': 0.5197896957397461, 'Text': 'hepcludex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 11, 'BeginOffset': 1105, 'EndOffset': 1114, 'Score': 0.8143712878227234, 'Text': 'hepcludex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.7333638072013855}]}, {'Text': 'the treatment', 'Type': 'TREATMENT', 'BeginOffset': 1231, 'EndOffset': 1244}, {'Text': 'the treatment', 'Type': 'TREATMENT', 'BeginOffset': 1255, 'EndOffset': 1268}, {'Text': 'the infection', 'Type': 'PROBLEM', 'BeginOffset': 1284, 'EndOffset': 1297}, {'Text': 'your disease', 'Type': 'PROBLEM', 'BeginOffset': 1309, 'EndOffset': 1321}, {'Id': 17, 'BeginOffset': 1340, 'EndOffset': 1351, 'Score': 0.9999995231628418, 'Text': 'immediately', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_DX_NAME', 'Traits': [], 'Attributes': [{'Type': 'DX_NAME', 'Score': 0.6414524912834167, 'RelationshipScore': 0.9346861243247986, 'RelationshipType': 'OVERLAP', 'Id': 14, 'BeginOffset': 1362, 'EndOffset': 1381, 'Text': 'changes in symptoms', 'Category': 'MEDICAL_CONDITION', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7441888451576233}]}]}, {'Text': 'any changes in symptoms', 'Type': 'PROBLEM', 'BeginOffset': 1358, 'EndOffset': 1381}, {'Text': 'stopping treatment', 'Type': 'TREATMENT', 'BeginOffset': 1388, 'EndOffset': 1406}, {'Id': 12, 'BeginOffset': 1456, 'EndOffset': 1465, 'Score': 0.4357150197029114, 'Text': 'hepcludex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. please tell your doctor if any of the side effects occur, or if you notice any side effects not listed in this leaflet. the following side effect is very common (this may affect more than 1 in 10 people): an increase in the level of bile acids in the blood. the following side effects are common (these may affect up to 1 in 10 people): headache dizziness nausea tiredness sleepiness faster than normal heartbeat (tachycardia) flu-like illness swollen abdomen (belly) itching joint pain muscle spasms reactions at the injection site that may include swelling, redness, irritation, bruising, itchiness, infection or pain excessive or uncontrolled sweating blood in urine redness of the skin rash. blood tests may also show: an increase in liver enzyme levels and bilirubin in the blood. these are usually raised in most diseases that cause damage to the liver; a decrease in red blood cells (anaemia); a reduction in immature red blood cells (reticulocytes); a reduction in white blood cells (eosinophils, lymphocytes, neutrophils), or platelets (thrombocytes) in the blood; a reduction in the level of haemoglobin in the blood ; an increase in the level of amylase and lipase in the blood (signs of possible pancreas damage); an increase of the international normalised ratio (inr) for blood clotting (which increases the risk of bleeding and bruising); an increase in the level of creatinine in the blood (a sign of kidney damage). reporting of side effects if you get any side effects, talk to your doctor 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 to provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'hepcludex', 'Type': 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{'Title': '5. how to store hepcludex', '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 vial after exp. the expiry date refers to the last day of that month. store in a freezer (-20 ). in order to protect from light, keep the vials in the outer carton. store up to three months in a refrigerator (2 -8)and do not freeze again. the reconstituted solution should be used immediately. however, if this is not possible it can be stored for up to 2 hours at a temperature of up to 25. do not throw away any medicines or used needles via wastewater or household waste. ask your pharmacist how to safely dispose medicines and used needles.', 'Entity_Recognition': [{'Text': 'hepcludex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 349, 'EndOffset': 350}, {'Text': 'the reconstituted solution', 'Type': 'TREATMENT', 'BeginOffset': 379, 'EndOffset': 405}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 494, 'EndOffset': 495}, {'Text': 'a temperature', 'Type': 'TEST', 'BeginOffset': 505, 'EndOffset': 518}, {'Text': '25.', 'Type': 'NUMBER', 'BeginOffset': 528, 'EndOffset': 531}, {'Text': 'any medicines', 'Type': 'TREATMENT', 'BeginOffset': 550, 'EndOffset': 563}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 657, 'EndOffset': 666}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what hepcludex contains the active substance is bulevirtide 2 mg. each vial contains bulevirtide acetate equivalent to 2 mg bulevirtide. the other ingredients are: sodium carbonate anhydrous, sodium hydrogen carbonate, mannitol, hydrochloric acid, sodium hydroxide. what hepcludex looks like and contents of the pack bulevirtide is a powder for solution for injection and comes as a white to off-white powder. each carton contains 30 single doses.', 'Entity_Recognition': [{'Text': 'hepcludex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 48, 'EndOffset': 59, 'Score': 0.9909323453903198, 'Text': 'bulevirtide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.8622627854347229, 'RelationshipScore': 0.9999998807907104, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 60, 'EndOffset': 65, 'Text': '2 mg.', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 60, 'EndOffset': 61}, {'Id': 2, 'BeginOffset': 85, 'EndOffset': 104, 'Score': 0.9912322163581848, 'Text': 'bulevirtide acetate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9776208996772766, 'RelationshipScore': 0.9379061460494995, 'RelationshipType': 'DOSAGE', 'Id': 3, 'BeginOffset': 119, 'EndOffset': 123, 'Text': '2 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '2 mg bulevirtide', 'Type': 'TREATMENT', 'BeginOffset': 119, 'EndOffset': 135}, {'Id': 5, 'BeginOffset': 164, 'EndOffset': 190, 'Score': 0.9991995692253113, 'Text': 'sodium carbonate anhydrous', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 6, 'BeginOffset': 192, 'EndOffset': 217, 'Score': 0.998734176158905, 'Text': 'sodium hydrogen carbonate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 7, 'BeginOffset': 219, 'EndOffset': 227, 'Score': 0.922237753868103, 'Text': 'mannitol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 229, 'EndOffset': 246, 'Score': 0.9972845315933228, 'Text': 'hydrochloric acid', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 248, 'EndOffset': 264, 'Score': 0.9994712471961975, 'Text': 'sodium hydroxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the pack bulevirtide', 'Type': 'TREATMENT', 'BeginOffset': 308, 'EndOffset': 328}, {'Text': 'a powder for solution', 'Type': 'TREATMENT', 'BeginOffset': 332, 'EndOffset': 353}, {'Text': 'injection', 'Type': 'TREATMENT', 'BeginOffset': 358, 'EndOffset': 367}, {'Text': 'white powder', 'Type': 'TREATMENT', 'BeginOffset': 396, 'EndOffset': 408}, {'Text': 'each carton', 'Type': 'TREATMENT', 'BeginOffset': 410, 'EndOffset': 421}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 431, 'EndOffset': 433}]}