Special populations

“There are insufficient data on the use of HIBSAGO in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental or reproductive effects were observed when bepirovirsen was administered subcutaneously to mice and rabbits at less than 1 (mouse) and approximately 3 (rabbits) times the maximum recommended human dose (MRHD), based on body surface area (BSA) comparisons (see Data).” (opens the prescribing information at this quote)CopyFlag

“The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.” (opens the prescribing information at this quote)CopyFlag

“Reduced fetal weights associated with maternal toxicity were observed at approximately 3 times the MRHD based on BSA comparison.” (opens the prescribing information at this quote)CopyFlag

“There are insufficient data on the presence of bepirovirsen or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Bepirovirsen was detectable in the milk of lactating mice without an effect on offspring (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk.” (opens the prescribing information at this quote)CopyFlag

“Although bepirovirsen was detected in the milk of lactating mice (on LD 10), systemic exposure of bepirovirsen in the offspring via milk was negligible.” (opens the prescribing information at this quote)CopyFlag

“The safety and effectiveness of HIBSAGO have not been established in patients less than 18 years of age.” (opens the prescribing information at this quote)CopyFlag

“the paediatric population from birth to less than 2 years of age;” (opens the source at this quote in a new tab)CopyFlag

“Open label, randomised, controlled study of pharmacokinetics (PK), safety and efficacy of bepirovirsen in children from 2 years to less than 18 years of age with chronic hepatitis B virus (HBV) infection.” (opens the source at this quote in a new tab)CopyFlag

“By May 2034” (opens the source at this quote in a new tab)CopyFlag

“Of the total number of patients who received treatment with HIBSAGO in the B-Well 1 and B-Well 2 trials, 128 (10%) were 65 years of age and older. The efficacy response was generally higher for age <65 versus that for age ≥65 years [see Clinical Studies (14)]. No overall differences in safety of HIBSAGO were observed between patients 65 years of age and older and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.” (opens the prescribing information at this quote)CopyFlag

“In the B-Well 1 and B-Well 2 trials, 21 (1%) participants were 75 years of age and older. Differences in efficacy in this age group versus younger adult patients cannot be determined due to the small number of participants.” (opens the prescribing information at this quote)CopyFlag

“No dosage adjustment is recommended in patients with mild renal impairment (eGFR 60 to 89 mL/min/1.73m2) [see Clinical Pharmacology (12.3)]. Insufficient data are available on the safety of HIBSAGO in patients with moderate or severe renal impairment or end stage renal disease (eGFR less than or equal to 59 mL/min/1.73m2). HIBSAGO can cause worsening renal function [see Warnings and Precautions (5.3)].” (opens the prescribing information at this quote)CopyFlag

“This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.” (opens the source at this quote in a new tab)CopyFlag

“The safety and efficacy of HIBSAGO in patients with cirrhosis have not been established. The use of HIBSAGO is contraindicated in chronic hepatitis B patients with acute hepatic impairment, or cirrhosis who have mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C) [see Contraindications (4), Clinical Pharmacology (12.3)].” (opens the prescribing information at this quote)CopyFlag

“Moderate HI did not have a clinically relevant impact on bepirovirsen PK or safety.” (opens the source at this quote in a new tab)CopyFlag

“The safety and efficacy of HIBSAGO have not been established in patients with hepatitis C virus (HCV) coinfection.” (opens the prescribing information at this quote)CopyFlag

“There are no data on the safety and efficacy of HIBSAGO in patients with HBV and hepatitis D virus (HDV) coinfection. HIBSAGO is not recommended in patients with HDV coinfection due to the potential for an exacerbated risk of clinically significant ALT increases.” (opens the prescribing information at this quote)CopyFlag

“Patients who are taking nucleos(t)ide analog reverse transcriptase inhibitors as part of antiretroviral therapy for HIV-1 and HBV coinfection must not stop taking their nucleos(t)ide analog reverse transcriptase inhibitor therapy unless an HIV healthcare provider has directed them to do so.” (opens the prescribing information at this quote)CopyFlag

“Participants were excluded from the trial if they had a history, suspicion, or evidence of cirrhosis; co-infection with HCV, HIV, or HDV; history or evidence of potential vasculitis; eGFR ≤60 mL/min/1.73m2; or platelet count <140 x 109/L.” (opens the prescribing information at this quote)CopyFlag

“This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.” (opens the source at this quote in a new tab)CopyFlag