Bulevirtide-Gmod: uses, dosing, side effects & brands
Bulevirtide-Gmod is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- Hepcludex
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How bulevirtide-gmod is dosed
From the FDA label for Hepcludex (application BLA761468). Other bulevirtide-gmod products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Bulevirtide-Gmod side effects
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…
Who shouldn’t take bulevirtide-gmod
None. None. ( 4 )
Bulevirtide-Gmod 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) ].
Every bulevirtide-gmod product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Hepcludex.
Related calculators
Frequently asked questions
What is bulevirtide-gmod?
Bulevirtide-gmod is an NTCP-directed HDV attachment inhibitor. Bulevirtide as an acetate salt, is a 47-amino acid protein with a fatty acid myristoyl residue at the N-terminus and an amidated C-terminus. All chiral amino acids are in the L-configuration.
Can you take bulevirtide-gmod with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run bulevirtide-gmod against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does bulevirtide-gmod come in?
Across the brands we track, bulevirtide-gmod is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic bulevirtide-gmod?
We do not currently list a generic-labelled bulevirtide-gmod product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Bulevirtide-Gmod: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bulevirtide-gmod
- MLA
- “Bulevirtide-Gmod: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bulevirtide-gmod.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for bulevirtide-gmod on DailyMed (NIH) ↗ — including its boxed warning in full.