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Trikafta Generic Name & Formulations
Legal Class
Rx
General Description
Elexacaftor, tezacaftor, ivacaftor; 50mg/25mg/37.5mg with ivacaftor 75mg; 100mg/50mg/75mg with ivacaftor 150mg; tabs.
Pharmacological Class
Cystic fibrosis transmembrane conductance regulator (CFTR) corrector + CFTR potentiator.
How Supplied
Tabs—84 (4×21)
Manufacturer
Generic Availability
NO
Trikafta Indications
Indications
Cystic fibrosis (CF) in patients ≥6yrs who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data.
Trikafta Dosage and Administration
Adult
Swallow whole. Take with fat-containing food (eg, eggs, cheeses, nuts, whole milk, meats). ≥12yrs: 2 tabs (100mg/50mg/75mg) in the AM and 1 tab (ivacaftor 150mg) in the PM, approx. 12hrs apart. Moderate hepatic impairment (not recommended; if needed, use with caution at reduced dose), concomitant moderate or strong CYP3A inhibitors: see full labeling.
Children
<6yrs: not established. Swallow whole. Take with fat-containing food (eg, eggs, cheeses, nuts, whole milk, meats). 6–<12yrs (<30kg): 2 tabs (50mg/25mg/37.5mg) in the AM and 1 tab (ivacaftor 75mg) in the PM, approx. 12hrs apart; (≥30kg): 2 tabs (100mg/50mg/75mg) in the AM and 1 tab (ivacaftor 150mg) in the PM, approx. 12hrs apart. Moderate hepatic impairment (not recommended; if needed, use with caution at reduced dose), concomitant moderate or strong CYP3A inhibitors: see full labeling.
Trikafta Contraindications
Not Applicable
Trikafta Boxed Warnings
Not Applicable
Trikafta Warnings/Precautions
Warnings/Precautions
If genotype is unknown, use an FDA-cleared CF mutation test to confirm the presence of at least 1 F508del mutation. Pre-existing advanced liver disease (eg, cirrhosis, portal hypertension, ascites, hepatic encephalopathy): avoid. Assess ALT/AST and bilirubin levels prior to initiation, every 3 months during the first year of treatment, and annually thereafter. Interrupt dosing and monitor closely if ALT/AST elevations >5×ULN or ALT/AST >3×ULN with bilirubin >2×ULN; after resolution, consider resuming therapy. History of hepatobiliary disease or LFT elevations; consider more frequent monitoring. Perform baseline and follow-up eye exams. Moderate hepatic impairment: see Adult, Children. Severe hepatic impairment: do not use. Severe renal impairment or ESRD. Pregnancy. Nursing mothers.
Trikafta Pharmacokinetics
See Literature
Trikafta Interactions
Interactions
Potentiated by strong (eg, ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin) or moderate (eg, fluconazole, erythromycin) CYP3A inhibitors; adjust dose. Avoid food or drink containing grapefruit. Antagonized by strong CYP3A inducers (eg, rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort); use not recommended. Caution with concomitant CYP2C9 substrates (eg, warfarin, glimepiride, glipizide), digoxin or other P-gp substrates with a narrow therapeutic index (eg, cyclosporine, everolimus, sirolimus, tacrolimus), OATP1B1 or OATP1B3 substrates (eg, statins, glyburide, nateglinide, repaglinide); monitor.
Trikafta Adverse Reactions
Adverse Reactions
Headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, ALT/AST increased, nasal congestion, blood CPK increased, rhinorrhea, rhinitis, influenza, sinusitis, blood bilirubin increased; non-congenital lens opacities/cataracts, hepatic injury.
Trikafta Clinical Trials
See Literature
Trikafta Note
Not Applicable
Trikafta Patient Counseling
See Literature
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