Ilaris(canakinumab)
ILARIS 150 MG in 1 ML Injection
NO BOXED WARNING
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Ilaris FAQs
What is the risk of using ILARIS during pregnancy?Available human data from postmarketing experience and published case reports on ILARIS use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. Canakinumab, like other monoclonal antibodies, is actively transported across the placenta mainly during the third trimester of pregnancy and may cause immunosuppression in the in utero exposed infant. In animal embryo-fetal development studies with marmoset monkeys, there was no evidence of embryotoxicity or fetal malformations with subcutaneous administration of canakinumab during the period of organogenesis and later in gestation at doses that produced exposures approximately 11 times the exposure at the maximum recommended human dose (MRHD) and greater. However, delays in fetal skeletal development were observed in marmoset monkeys following prenatal exposure to ILARIS at concentrations approximately 11 times the MRHD and greater. Similar delays in fetal skeletal development were observed in mice administered a murine analog of ILARIS during the period of organogenesis. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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.
Is ILARIS safe and effective for lactating women?There is no information regarding the presence of canakinumab in human milk or the effects on milk production. There are a small number of published case reports that do not establish an association between maternal canakinumab use during lactation and adverse effects on breastfed infants. Maternal IgG is known to be present in human milk. The effects of canakinumab in breast milk and possible systemic exposure in the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ILARIS and any potential adverse effects on the breastfed infant from ILARIS or from the underlying maternal condition.
What is the age range of pediatric patients included in the CAPS trials with ILARIS?The CAPS trials with ILARIS included a total of 23 pediatric patients with an age range from 4 years to 17 years. The majority of patients achieved improvement in clinical symptoms and objective markers of inflammation.
Is ILARIS safe and effective in pediatric patients?Overall, the efficacy and safety of ILARIS in pediatric and adult patients were comparable. In the TRAPS, HIDS/MKD, and FMF trial, which included a total of 102 pediatric patients, there were no clinically meaningful differences in the efficacy, safety, and tolerability profile of ILARIS in pediatric patients compared to the overall TRAPS, HIDS/MKD, and FMF populations. The majority of pediatric patients achieved improvement in clinical symptoms and objective markers of inflammation.
Is ILARIS safe and effective for CAPS patients under 4 years of age?The safety and effectiveness of ILARIS in CAPS patients under 4 years of age has not been established.
Is ILARIS safe and effective for SJIA patients under 2 years of age?The safety and efficacy of ILARIS in SJIA patients under 2 years of age have not been established.
Should pediatric patients receive all recommended vaccinations before starting therapy with ILARIS?Yes, because IL-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with ILARIS, pediatric patients receive all recommended vaccinations. Live virus vaccines should be avoided concurrently with ILARIS treatment in pediatric patients or in infants exposed in utero following maternal administration.
Is ILARIS safe and effective for patients with renal impairment?No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with renal impairment.
Is ILARIS safe and effective for patients with hepatic impairment?No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with hepatic impairment.
Were patients aged 65 years and older included in clinical studies of ILARIS?Clinical studies of ILARIS did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.
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