Benlysta(belimumab)
Benlysta 120 MG Injection
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Benlysta FAQs
Is there a pregnancy exposure registry for BENLYSTA?Yes, there is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to BENLYSTA during pregnancy. Healthcare professionals are encouraged to refer patients, and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.
What is the risk summary for BENLYSTA use during pregnancy?Available data on the use of BENLYSTA in pregnant women are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect the immune response in the in utero-exposed infant. In an animal study, there was no evidence of fetal harm with exposures approximately 9 times (based on intravenous administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose. Based on animal data and the mechanism of action of belimumab, the immune system in infants of treated mothers may be adversely affected. It is unknown whether immune effects, if identified, are reversible.
What is the estimated background risk of major birth defects and miscarriage for the indicated population?The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
What are the disease-associated maternal and/or embryo/fetal risks associated with SLE in pregnancy?Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block.
Is there any information available on the presence of belimumab in human milk?No information is available on the presence of belimumab in human milk or the effects of the drug on the breastfed infant or the effects of the drug on milk production. If belimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to belimumab are unknown.
What is the age range for pediatric use of BENLYSTA?BENLYSTA has been established for the treatment of SLE and lupus nephritis in pediatric patients aged 5 to 17 years old. The safety and effectiveness of intravenous administration of BENLYSTA have not been established in pediatric patients younger than 5 years of age. The safety and effectiveness of subcutaneous administration of BENLYSTA have not been established in pediatric patients younger than 18 years of age.
What evidence supports the use of BENLYSTA in pediatric patients with SLE?The use of BENLYSTA in pediatric patients with SLE is supported by evidence from pharmacokinetic (PK) and efficacy results from a pediatric study (Trial 6), as well as PK exposure and extrapolation of the established efficacy of BENYLSTA plus standard therapy from the Phase 3 intravenous studies in adults with SLE. A randomized, double-blind, placebo-controlled, PK, efficacy, and safety study (Trial 6) to evaluate intravenously administered BENLYSTA 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with SLE. The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving BENLYSTA plus standard therapy compared with placebo plus standard therapy. Pediatric patients receiving BENLYSTA plus standard therapy also had a lower risk of experiencing a severe flare compared with placebo plus standard therapy. Pharmacokinetics were evaluated in a total of 53 pediatric patients with SLE and were consistent with the adult population with SLE.
What evidence supports the use of BENLYSTA in pediatric patients with lupus nephritis?The use of BENLYSTA in pediatric patients with active lupus nephritis is based on the extrapolation of efficacy from the intravenous study in adults (n = 224) with active lupus nephritis, and supported by pharmacokinetic data from intravenous studies in adults (n = 224) with active lupus nephritis and from pediatric patients (n = 53) with SLE. Estimated belimumab exposures for pediatric patients were comparable to adults with active lupus nephritis.
Are there any age-related precautions for the use of BENLYSTA?The safety and effectiveness of intravenous administration of BENLYSTA have not been established in pediatric patients younger than 5 years of age. The safety and effectiveness of subcutaneous administration of BENLYSTA have not been established in pediatric patients younger than 18 years of age. There are no specific precautions related to geriatric use of BENLYSTA, although clinical studies did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects. Use with caution in geriatric patients.
What renal impairment levels were included in the BENLYSTA studies?The safety and efficacy of BENLYSTA were evaluated in studies that included patients with SLE who had mild (creatinine clearance [CrCl] ≥60 and <90 mL/min), moderate (CrCl ≥30 and <60 mL/min), or severe (CrCl ≥15 and <30 mL/min) renal impairment. No dosage adjustment is recommended in patients with renal impairment.
Were there any dosage adjustments recommended for patients with renal impairment?No dosage adjustment is recommended in patients with renal impairment.
Were there any formal trials conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab?No formal trials were conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab. No dosage adjustment is recommended in patients with hepatic impairment.
Were there any differences in response rates between Black patients and non-Black patients in BENLYSTA studies?In Trial 2 and Trial 3 (intravenous dosing), SLE Responder Index-4 (SRI-4) response rates were lower for Black patients receiving BENLYSTA plus standard therapy relative to Black patients receiving placebo plus standard therapy. In Trial 4 (intravenous dosing), a 2:1 randomized, placebo-controlled trial in Black patients, SLE Responder Index (SRI-S2K) response rates were higher for Black patients receiving BENLYSTA plus standard therapy relative to Black patients receiving placebo plus standard therapy, but the treatment difference was not statistically significant. In Trial 7 (subcutaneous dosing), SRI-4 response was higher in Black patients receiving BENLYSTA plus standard therapy compared with Black patients receiving placebo plus standard therapy. The safety profile of BENLYSTA in Black patients was consistent with the known safety profile of BENLYSTA administered in the overall population.
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