Hepcludex (bulevirtide-gmod) is filed as Sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on participants who achieved a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 14 )
HEPCLUDEX is an antiviral drug (NTCP-directed HDV attachment inhibitor).
WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B See full prescribing information for complete boxed warning . Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. ( 5.1 )
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment. ( 5.2 ) 5.1 Exacerbation of Hepatitis D and B After Discontinuation of Treatment Severe acute exacerbations of HDV and HBV infection may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including monitoring HBV DNA and HDV RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. 5.2 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment [see Adverse Reactions (6.2) ] .
4 CONTRAINDICATIONS None. None. ( 4 )
Injection site reactions (≥10%); Headache (≥10%); Abdominal pain (≥10%); Fatigue (≥10%); Pruritus (≥10%)
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Exacerbation of Hepatitis D and B After Discontinuation of Treatment [see Warnings and Precautions (5.1) ]. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HEPCLUDEX are injection site reactions, headache, abdominal pain, fatigue, and pruritus . ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The overall safety profile of HEPCLUDEX is based on Phase 2 and Phase 3 data from 165 adults with chronic HDV infection without cirrhosis or with compensated cirrhosis who received at least 48 weeks of HEPCLUDEX 8.5 mg subcutaneous injection once daily. Trial MYR301 was a Phase 3 randomized, multi-center, open-label, parallel-arm trial in 101 adults. In this trial, 50 adults received 8.5 mg HEPCLUDEX daily for 144 weeks and 51 adults who were in the Delayed Treatment group received no HDV treatment for the first 48 weeks; 50 adults in the Delayed Treatment group then received HEPCLUDEX 8.5 mg once daily for 96 weeks [see Clinical Studies (14) ]. Table 1 displays the frequency of the adverse reactions (all grades) ≥ 10% in the HEPCLUDEX group at Week 48. No participant discontinued treatment with HEPCLUDEX due to an adverse reaction through Week 48. Table 1 Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. (All Grades) Reported in ≥ 10% of Participants with Chronic HDV Infection Without Cirrhosis or With Compensated Cirrhosis Receiving HEPCLUDEX in Trial MYR301 (Week 48 Analysis) Adverse Reaction HEPCLUDEX (N=50) Delayed Treatment Participants who received no HDV treatment in Trial MYR301 for the first 48 weeks. (N=51) Injection site reactions Grouped term includes injection site abscess, injection site erythema, injection site reaction, injection site pruritus, injection site swelling, injection site hematoma, injection site rash, injection site dermatitis, and injection site pain. 30% 0 Headache 20% 0 Abdominal pain Grouped term includes abdominal pain, abdominal pain lower, and abdominal pain upper. 18% 2% Fatigue 14% 2% Pruritus 14% 0 A similar safety profile was observed through Week 144 in Trial MYR301 and for participants in the Delayed Treatment group who switched to treatment with HEPCLUDEX at Week 48 through to Week 144. Additionally, a similar safety profile was observed through Week 96 in Phase 2b Trial MYR204. Laboratory Abnormalities Eosinophil Count Increased: In MYR301, increases in eosinophil counts were reported in 33% of participants (all Grade 1) receiving HEPCLUDEX; there were no associated clinical sequelae, hepatic adverse reactions, or significant liver-related laboratory abnormalities. Total Bile Salts Increased: HEPCLUDEX inhibits sodium taurocholate co-transporting polypeptide (NTCP)-mediated bile acid transport. Consistent with this, elevations in total serum bile salt levels were observed in clinical trials of HEPCLUDEX. In MYR301, all participants who received HEPCLUDEX had elevated serum bile salts. Bile salt levels showed visit-to-visit variability and peaked by Week 8 of treatment in both participants without cirrhosis and those with compensated cirrhosis, although median levels trended higher in the latter group. Bile salt elevations resolved upon discontinuation of HEPCLUDEX. In MYR301, 14% of HEPCLUDEX recipients experienced Grade 1 or 2 pruritus that was self-limited. The magnitude of total serum bile salt elevations did not correlate with the severity of pruritus. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of HEPCLUDEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: hypersensitivity, including anaphylactic reaction
2 DOSAGE AND ADMINISTRATION Recommended dosage in adults: HEPCLUDEX 8.5 mg once daily by subcutaneous injection. ( 2.1 ) Instructions for Use should be followed for preparation and administration of HEPCLUDEX. ( 2.2 ) 2.1 Recommended Dosage in Adults The recommended dosage in adults is HEPCLUDEX 8.5 mg once daily administered by subcutaneous injection. HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown. In all patients, manage the underlying hepatitis B virus (HBV) infection as clinically appropriate. If a dose is missed, that dose should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume the original schedule. 2.2 Dose Preparation and Administration See the HEPCLUDEX full Instructions for Use for details on the preparation and administration of HEPCLUDEX. Healthcare professionals should train patients or caregivers on the proper reconstitution and administration of HEPCLUDEX, and subcutaneous injection techniques. Consider preparation and administration of the first dose under healthcare professional supervision. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Aseptically reconstitute HEPCLUDEX lyophilized powder or cake by adding 1 mL of Sterile Water for Injection to the HEPCLUDEX vial. Administer entire contents of vial by subcutaneous injection into the upper thigh, lower abdomen, or back of the upper arm (only if administered by a caregiver). Use reconstituted product immediately. Do not store for later use.
7 DRUG INTERACTIONS 7.1 Effects of HEPCLUDEX on Other Drugs No CYP enzyme or transporter mediated inhibition or induction by bulevirtide is anticipated at clinically relevant concentrations [see Clinical Pharmacology (12.3) ]. 7.2 Effects of Other Drugs on HEPCLUDEX Due to peptide catabolism of bulevirtide, the drug-drug interaction potential of other drugs to impact bulevirtide pharmacokinetics, via CYP enzymes, is low [see Clinical Pharmacology (12.3) ].
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ) for proper preparation and administration instructions. Important Preparation and Administration Considerations Healthcare professionals should train patients or caregivers in the proper technique for reconstituting HEPCLUDEX with Sterile Water for Injection and administering subcutaneous injections using a syringe and consider preparation and administration of the first dose under the supervision of a healthcare provider. Inform patients that the Sterile Water for Injection, syringes, and needles needed for preparation and injection of HEPCLUDEX are obtained separately from the pharmacy. Exacerbation of Hepatitis D and B after Discontinuation of Treatment Inform patients that discontinuation of HEPCLUDEX may result in severe acute exacerbations of hepatitis D and B. Advise the patient to inform their healthcare provider before they discontinue HEPCLUDEX [see Warnings and Precautions (5.1) ]. Hypersensitivity Reactions Including Anaphylaxis Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. Advise patients to immediately discontinue HEPCLUDEX and alert their healthcare provider if signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur [see Warnings and Precautions (5.2) ] . Missed Dosage Inform patients that it is important to take HEPCLUDEX on a regular dosing schedule and to avoid missing doses. If a dose is missed, that dose should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume the original schedule [see Dosage and Administration (2.1) ]. Treatment Duration Advise patients that in the treatment of chronic hepatitis D, the optimal duration of treatment is unknown [see Dosage and Administration (2.1) ].
According to its FDA label, Hepcludex (bulevirtide-gmod) is approved for: 1 INDICATIONS AND USAGE HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotran… For medical advice, please talk to your prescriber or pharmacist.
Hepcludex (bulevirtide-gmod) belongs to the Sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor class of medications.
The FDA label lists Hepcludex (bulevirtide-gmod) as: 3 DOSAGE FORMS AND STRENGTHS For injection: 8.5 mg as a white to off-white lyophilized powder or cake in a single-dose vial for reconstitution. For injection: 8.5 mg as a lyophilized powder or cake, in a single-dose vial. ( 3 ); subcutaneous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Hepcludex. Availability changes as patents expire.
Yes. The FDA label for Hepcludex (bulevirtide-gmod) carries a Boxed Warning. Excerpt: "WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be…" See the full FDA label for the complete warning. For medical advice, please talk to your prescriber or pharmacist.
The FDA Enforcement Report does not show an active/ongoing recall for Hepcludex (bulevirtide-gmod) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Hepcludex (bulevirtide-gmod) as 2026-05-22.
The FDA label lists Gilead Sciences, Inc. as a labeler/manufacturer of Hepcludex (bulevirtide-gmod). Multiple firms may market generics of the same molecule.
The FDA label states: "Store HEPCLUDEX vials at room temperature between 68 °F to 77 °F (20 °C to 25 °C), excursions permitted from 59 °F to 86 °F (15 °C to 30 °C). After reconstitution, use vials immediately. Discard unused portion." Follow the packaging insert for the authoritative guidance.
Loading full data from Know Your Drugs Institute…