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Hibsago (bepirovirsen)

Chronic hepatitis B virus infection in adults without cirrhosis

Also known as GSK3228836
Manufacturer
GSK
Last updated
190 sources

Product information and disease descriptionProduct descriptionProduct information

Dosage forms and strengths

6 evidence topics · 1 source

Dosage form and strength

“Injection: 150 mg/mL of bepirovirsen as a clear, colorless to yellow sterile solution with no visible particulates in a single-dose prefilled glass syringe within a safety syringe device.” (opens the prescribing information at this quote)

Package and national drug code

“HIBSAGO injection is supplied as 150 mg/mL, single-dose, prefilled glass syringe with attached 27-gauge, 0.5 inch (12.7 mm) needle with a needle guard in cartons of 2 (NDC 0173-0941-39).” (opens the prescribing information at this quote)

“Each single-dose prefilled syringe delivers 150 mg of bepirovirsen in 1 mL of solution.” (opens the prescribing information at this quote)

Syringes per dose

“For a 300 mg dose, administer 2 x 150 mg pre-filled syringes, inject one right after the other.” (opens the prescribing information at this quote)

“For a 150 mg dose administer 1 x 150 mg pre-filled syringe injection.” (opens the prescribing information at this quote)

Solution, excipients, and latex

“HIBSAGO injection for subcutaneous use is a sterile, preservative-free, clear, colorless to yellow solution with no visible particulates.” (opens the prescribing information at this quote)

“Each 1 mL delivers 150 mg bepirovirsen, equivalent to 159 mg of bepirovirsen sodium, in 1 mL water for injection and may contain hydrochloric acid or sodium hydroxide to adjust to pH 8.” (opens the prescribing information at this quote)

“The syringes are not made with natural rubber latex.” (opens the prescribing information at this quote)

Storage before and after dispensing

“Prior to Dispensing: Store in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Store in the original carton to protect from light. Do not shake.” (opens the prescribing information at this quote)

“Following Dispensing: Store HIBSAGO at room temperature up to 86°F (30°C) for 12 weeks. Do not freeze.” (opens the prescribing information at this quote)

“Discard if the expiry date has passed, or it has been 12 weeks since carton was received, whichever comes first.” (opens the prescribing information at this quote)

“HIBSAGO injection must be administered within 6 hours once removed from the carton. Discard if not administered within 6 hours.” (opens the prescribing information at this quote)

Preparation before injection

“Ensure HIBSAGO has been at room temperature (below 86°F [30°C]) for a minimum of 30 minutes prior to injection” (opens the prescribing information at this quote)

Material safety data sheet

No evidence found.