--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Administration" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Administration. Topics: Route, supervised first dose, and self-administration; Prefilled syringe and needle; Preparation before injection; Injection sites, two-syringe dose, and site rotation; 5 further topics. 9 evidence topics quoted from 3 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/administration" published: "2026-10-21T22:39:04-04:00" modified: "2026-10-22T19:07:03-04:00" --- # Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Administration ## 2.1.2.10.2 Administration ### Route, supervised first dose, and self-administration > “HIBSAGO must be administered under the guidance and supervision of a healthcare provider for the initial dose to ensure proper injection technique.” > “Patients or caregivers may administer HIBSAGO after their healthcare provider determines that it is appropriate and with medical follow-up, including laboratory testing. Healthcare providers must provide proper training in subcutaneous injection technique before the patient or caregivers can administer HIBSAGO” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) > “Six-month treatment with option of self-administration after first dose” Source: [GSK press release, Hibsago US approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/) ### Prefilled syringe and needle > “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.” > “HIBSAGO injection is supplied as two, 1-mL, single-dose, prefilled syringes with a 0.5 inch (12.7 mm), 27-gauge, stainless steel needle assembled with a needle guard.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Preparation before injection > “Ensure HIBSAGO has been at room temperature (below 86°F [30°C]) for a minimum of 30 minutes prior to injection” > “Prior to administration, visually inspect the window of the prefilled syringes for particulate matter or discoloration. HIBSAGO injection should be clear and colorless to yellow and free of visible particulate matter. Do not use HIBSAGO injection if the product exhibits discoloration, cloudiness, or particulate matter. Do not shake the HIBSAGO syringe. Do not use the syringes if they have been dropped or damaged.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Injection sites, two-syringe dose, and site rotation > “Inject into the thigh or abdomen, avoiding the 2 inches (5 cm) around the navel. The outer area of the upper arm can also be used if a caregiver administers the subcutaneous injections.” > “For a 300 mg dose, administer 2 x 150 mg pre-filled syringes, inject one right after the other. Choose a different injection site for each injection, at least 2 inches (5 cm) from the other injection sites” > “For a 150 mg dose administer 1 x 150 mg pre-filled syringe injection.” > “Never give injections into areas where the skin is tender, bruised, red, or hard. Rotate injection sites to reduce the risk of injection site reactions” > “Ensure that injection sites are rotated from one week to the next and that the two injections administered weekly to constitute the recommended dose of HIBSAGO are separated by at least 2 inches (5 cm).” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Storage and handling 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.” > “Following Dispensing: Store HIBSAGO at room temperature up to 86°F (30°C) for 12 weeks.” > “Discard if the expiry date has passed, or it has been 12 weeks since carton was received, whichever comes first.” > “HIBSAGO injection must be administered within 6 hours once removed from the carton. Discard if not administered within 6 hours.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Instructions for Use: preparation, injection, and disposal steps > “Make sure HIBSAGO has been at room temperature up to 86°F (30°C) for at least 30 minutes before using it. Cold medicine is more painful to inject.” > “If you are giving yourself the injection, you can inject into your thighs or stomach (abdomen).” > “A caregiver can inject into the upper arm, thigh, or abdomen.” > “Do not inject yourself in the upper arm.” > “Inject within 5 minutes after you remove the gray needle cap.” > “Hold the middle of the syringe and insert the entire needle into the pinched skin at a 45-degree angle using a dart like motion, as shown.” > “Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of the syringe and all of the medicine is injected.” > “For a 300 mg dose, give your second injection immediately, to complete your dose, by repeating all Inject steps (Steps B1 through B5).” > “Put your used HIBSAGO syringe(s) and gray needle cap(s) in an FDA-cleared sharps disposal container right away.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Patient counseling on administration technique > “Train patients and caregivers on the importance of proper subcutaneous administration technique, the necessity of rotating injection sites and how to use the prefilled syringe. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use HIBSAGO” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Self-administration with the prefilled syringe: relative bioavailability study > “Participants (N = 159) received a single 300 mg SC dose of bepirovirsen administered by a HCP (vial [n = 46] or PFS SSD [n = 49]), or self‐administered (PFS SSD, with [n = 32] or without [n = 32] training from a HCP).” > “The GMR (90% CI) with participant training (Group 2 versus Group 3) was 1.02 (0.88, 1.18) for Cmax and 0.98 (0.88, 1.09) for AUC(0‐inf), and without participant training (Group 2 versus Group 4) was 0.99 (0.87, 1.13) for Cmax and 0.97 (0.87, 1.08) for AUC(0‐inf).” > “The proportion of participants experiencing injection site reactions was higher when PFS SSD was self‐administered (Group 3: 32/32 [100%], Group 4: 30/32 [94%]) compared with HCP administration (Group 2: 43/49 [88%]).” > “While 6 participants received an incomplete dose of bepirovirsen, owing to incorrect use of the PFS (4 of them injected approximately 75% to 95% of the dose), device usability was evaluated in separate formative and summative human factors studies, and the device and instructions for use were successfully validated for self‐administration (unpublished data).” Source: [Youssef et al. (2026)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12856967/) ### Injection site and exposure > “Bepirovirsen exposure differed by SC injection site, with lower exposure observed when the SC injection was administered in the thigh compared with the abdomen or upper arm.” Source: [Youssef et al. (2026)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12856967/) ## Related pages - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Terms and abbreviations](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations.md) - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Product information and disease description](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Clinical evidence](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: new drug review](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: cost-effectiveness analyses and utility weights](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses.md)