The COSENTYX Co-pay Program includes the Co-pay Card, Payment Card (if applicable), and Rebate, with a combined annual limit up to $16,000. Valid only for those with private insurance. Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens.Program Terms & Conditions: Limitations apply.The safety profile for the patients with CF receiving TRIKAFTA (N=55) enrolled in the 4-week, randomized, double-blind, active-controlled Phase 3 trial (Trial 2) was similar to that observed in Trial 1.Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs The safety and effectiveness of TRIKAFTA in patients with CF younger than 6 years of age have not been established.Baseline and follow up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens.The safety profile in patients age 6 to less than 12 years from an open-label Phase 3 trial (N=66) was similar to that observed in trials of patients age 12 years and olderĬlick here to access full Prescribing Information for TRIKAFTA.The safety profile for the patients with CF receiving TRIKAFTA (N=55) enrolled in the 4-week, randomized, double-blind, active-controlled Phase 3 trial (Trial 2) was similar to that observed in Trial 1.The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA (N=202) and higher than placebo (N=201) by ≥1% in the 24-week placebo-controlled, parallel-group Phase 3 trial (Trial 1) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, and blood bilirubin increased.Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs The safety and effectiveness of TRIKAFTA in patients with CF younger than 6 years of age have not been established.Baseline and follow up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens.The dose of TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors Exposure to elexacaftor, tezacaftor, and ivacaftor are increased when co-administered with strong or moderate CYP3A inhibitors.Co‑administration with strong CYP3A inducers is not recommended Exposure to ivacaftor is significantly decreased and exposure to elexacaftor and tezacaftor are expected to decrease by the concomitant use of strong CYP3A inducers, which may reduce the therapeutic effectiveness of TRIKAFTA.For patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered.Following the resolution of liver function test elevations, consider the benefits and risks of resuming treatment ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN, dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve.
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