Prescription medicine
Bulevirtide Brand names: Hepcludex
Bulevirtide (Hepcludex) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the bulevirtide FDA label on DailyMed (effective May 22, 2026); every bulevirtide label on DailyMed.
Highlights of the record
FDA label of May 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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.
Used for
From the label: indications and usageHEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.
Forms and strengths
- 8.5 mg
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 77 through July 30, 2026
What is bulevirtide used for?
From the label: indications and usageHEPCLUDEX 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). […]
Source: FDA drug label (HEPCLUDEX), Gilead Sciences, Inc., effective May 22, 2026 (SPL set 12391cc2-38c2-4cf5-86d3-2be9370127fc), via openFDA; the full label on DailyMed
What does the patient leaflet for bulevirtide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about HEPCLUDEX?HEPCLUDEX can cause serious side effects, including: Worsening of hepatitis delta virus (HDV) and hepatitis B virus (HBV) infection. Your HDV or HBV infection may get worse (flare-up) if you stop taking HEPCLUDEX, especially if you have cirrhosis. A "flare-up" is when your HDV or HBV infection suddenly returns in a worse way than before. Do not run out of HEPCLUDEX. Refill your prescription or talk to your healthcare provider before your HEPCLUDEX is all gone. Do not stop taking HEPCLUDEX without first talking to your healthcare provider. If you stop taking HEPCLUDEX, your healthcare provider will need to check your health often and do blood tests regularly for at least 6 months to check your liver, and may give you medicine to treat your virus infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking HEPCLUDEX. For more information about side effects, see " What are the possible side effects of HEPCLUDEX? " What is HEPCLUDEX? HEPCLUDEX is a prescription medicine used to treat chronic (long-lasting) hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. It is not known if HEPCLUDEX is safe and effective in children less than 18 years of age. Before taking HEPCLUDEX, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if HEPCLUDEX can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if HEPCLUDEX can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with HEPCLUDEX. […]
From the patient leaflet: How should I store HEPCLUDEX?Store HEPCLUDEX vials at room temperature between 68 °F to 77 °F (20 °C to 25 °C). After mixing, use HEPCLUDEX vial right away. Throw away (discard) unused portion. Keep HEPCLUDEX and all medicines out of reach of children.
Source: FDA drug label (HEPCLUDEX), Gilead Sciences, Inc., effective May 22, 2026 (SPL set 12391cc2-38c2-4cf5-86d3-2be9370127fc), via openFDA; the full label on DailyMed
Is there a generic for bulevirtide (Hepcludex)?
No generic bulevirtide is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for bulevirtide?
The FDA Adverse Event Reporting System holds 77 reports that list bulevirtide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 20 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Bulevirtide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other