Brand names: Siliq
Interleukin-17 Receptor A Antagonist · Interleukin 17 Receptor A Antagonists
Route: Subcutaneous
FDA Black Box Warning
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [ see Warnings and Precautions ( 5.1 )]. Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions ( 5.2 )]. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning. • Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. ( 5.1 , 6.1 ) • Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. ( 5.1 ) • Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. ( 5.1 ) • Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. ( 5.1 ) • SILIQ is available only through a restricted program called the SILIQ REMS Program. ( 5.2 )
Contraindications
4 CONTRAINDICATIONS SILIQ is contraindicated in patients with: • Crohn’s disease because SILIQ may cause worsening of disease [see Warnings and Precautions ( 5.7 )] . • Clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or component of the container. Hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SILIQ [see Warnings and Precautions ( 5.3 )] . • Crohn’s disease ( 4 ) • Clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or component of the container ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no human data on SILIQ use in pregnant women to inform a drug-associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, 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) [see Data]. 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. Data Animal Data A combined embryofetal development and pre- and postnatal development study was conducted in cynomolgus monkeys administered brodalumab. No brodalumab-related effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from pregnant monkeys administered weekly subcutaneous doses of brodalumab up to 26 times the MRHD from the beginning of organogenesis to parturition (on a mg/kg basis of 90 mg/kg/week).
2 interactions on record
SILIQ may modulate serum levels of cytokines affecting CYP450 enzyme formation, potentially altering cyclosporine metabolism. Monitor drug concentration and consider dosage modification upon initiation or discontinuation of SILIQ.
Source: NLP:brodalumab
SILIQ may modulate serum levels of cytokines affecting CYP450 enzyme formation, potentially altering warfarin metabolism. Monitor for effect upon initiation or discontinuation of SILIQ.
Source: NLP:brodalumab