Molecule
Bepirovirsen is a prescription medicine indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis, among other approved uses. MedsAcross supplies Bepirovirsen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
HIBSAGO is indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis: • who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and • who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test.
Source: US FDA prescribing information
HIBSAGO is an antiviral drug against HBV.
Source: US FDA prescribing information
• Refer to the full prescribing information for additional important dosage information. • HIBSAGO is administered by subcutaneous injection and must be used in combination with NrtI therapy. • Weeks 1 and 2: The recommended dosage of HIBSAGO is 300 mg (administered as two 150 mg subcutaneous injections) twice a week allowing 3 or 4 days between each dose. • Weeks 3 to 24: The recommended dosage of HIBSAGO is 300 mg (administered as two 150 mg subcutaneous injections) once a week on the same day each week. • Laboratory tests must be measured prior to, during, and following discontinuation of treatment. • Dosage modification is recommended in patients experiencing elevated liver laboratory values, platelet count reductions or eGFR decline.
Source: US FDA prescribing information
HIBSAGO is contraindicated in patients: • with acute hepatic impairment, or cirrhosis who have mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C). • with a platelet count below 100 x 10 9 /L prior to initiation of treatment. • Patients with acute hepatic impairment, or cirrhosis who have mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B or C). • Patients with platelet count below 100 x 10 9 /L prior to initiation of treatment
Source: US FDA prescribing information
Boxed warning (on-treatment hepatic flares and thrombocytopenia): On-Treatment Hepatic Flares HIBSAGO may cause on-treatment hepatic flares with increases in ALT of >20-40x ULN associated with decline in HBsAg. Some cases were associated with hyperbilirubinemia. Most occurred in the first 12 weeks of treatment and resolved when treatment was interrupted or permanently discontinued. • Worsening renal function has been observed with HIBSAGO. Evaluating eGFR and urine albumin‑creatinine ratio (uACR) prior to treatment and monitoring eGFR during treatment is necessary for appropriate dosing. • Serious inflammatory and immune adverse reactions have occurred. If signs and symptoms suggestive of vasculitis/immune-associated events occur, and no alternative cause is identified, permanently discontinue treatment with HIBSAGO.
Source: US FDA prescribing information
The following adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: • On-Treatment Hepatic Flares. • Thrombocytopenia. • Worsening Renal Function. • Inflammatory and Immune Effects. • Serious Adverse Reaction with Improper Administration. The most common adverse reactions (incidence ≥10%) are injection site reactions, pyrexia, fatigue, and headache.
Source: US FDA prescribing information
• Monitor patients for signs of bleeding and thrombocytopenia if HIBSAGO is taken concomitantly with anticoagulants, antiplatelets or drugs that decrease platelet count. • Monitor patients for signs of worsening renal function during concomitant administration of HIBSAGO with drugs that may impair renal function. • Concomitant administration of HIBSAGO and peginterferon alfa-2a is not recommended.
Source: US FDA prescribing information
Prior to Dispensing: Store in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Following Dispensing: Store HIBSAGO at room temperature up to 86°F (30°C) for 12 weeks. Do not freeze. Store in the original carton to protect from light. Do not shake. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Bepirovirsen, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Hibsago 150 mg/1 mL injectionSubcutaneous Cold chain | GlaxoSmithKline | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 October 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Bepirovirsen and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Bepirovirsen, including Hibsago.
Yes. The US FDA first approved Bepirovirsen on 20 October 2026, according to Drugs@FDA.
At least one listed presentation of Bepirovirsen must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.