Siliq(brodalumab)
SILIQ 210 MG in 1.5 ML Prefilled Syringe
Dosage & Administration
Dosage & Administration
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Siliq FAQs
What is the risk of using SILIQ during pregnancy?There are no human data on SILIQ use in pregnant women to inform a drug-associated risk. SILIQ may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of brodalumab during organogenesis through parturition at doses up to 26 times the maximum recommended human dose (MRHD). However, the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
What is the risk of using SILIQ during lactation?There are no data on the presence of brodalumab in human milk, the effects on the breastfed infant, or the effects on milk production. Brodalumab was detected in the milk of lactating cynomolgus monkeys. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SILIQ and any potential adverse effects on the breastfed infant from SILIQ or from the underlying maternal condition.
Is SILIQ safe and effective for pediatric patients?The safety and effectiveness of SILIQ have not been evaluated in pediatric patients.
Is SILIQ safe and effective for geriatric patients?Of the 3066 plaque psoriasis subjects initially randomized to SILIQ in clinical trials, 192 (6%) were ≥ 65 years old and no subjects were ≥ 75 years old. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects.
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