(fidanacogene elaparvovec-dzkt)
Risk Summary
BEQVEZ is not intended for administration in women. There are no data from the use of BEQVEZ in pregnant women. No animal reproductive studies have been conducted with BEQVEZ.
In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Risk Summary
There is no information regarding the presence of BEQVEZ in human milk, the effect on the breastfed infant, and the effects on milk production.
BEQVEZ is not intended for administration in women.
No studies in animals or clinical studies have been performed to evaluate the potential effects of BEQVEZ on fertility in humans.
Contraception
Males
Vector DNA was shed in semen but declined to undetectable levels in semen within a mean of 1 to 4 months after infusion. Male patients should refrain from donating sperm, be abstinent or use a male condom for up to 6 months after receiving BEQVEZ [see Clinical Pharmacology (12.3)].
The safety and efficacy of BEQVEZ in pediatric patients have not been established.
The clinical study did not have any patient ≥65 years of age. The safety and efficacy of BEQVEZ have not been established in geriatric patients.
Clinical studies of BEQVEZ included a limited number of HIV patients, which precludes a determination of whether the efficacy and safety data differ when compared to patients without HIV infection.
The safety and effectiveness of BEQVEZ in patients with prior or active factor IX inhibitors have not been established [see Clinical Pharmacology (12.6)]. Patients with history of or active factor IX inhibitors should not take BEQVEZ.
After administration of BEQVEZ, patients should be monitored for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests [see Warnings and Precautions (5.4)].
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