These highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA.
TRIKAFTA� (elexacaftor, tezacaftor and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene.
If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation. (1)
DOSAGE AND ADMINISTRATION
Adults and pediatric patients aged 12 years and older:
Morning dose: two elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg tablets
Evening dose: one ivacaftor 150 mg tablet
Morning and evening dose should be taken approximately 12 hours apart with fat-containing food. (2.1, 12.3)
Should not be used in patients with severe hepatic impairment. Use not recommended in patients with moderate hepatic impairment unless the benefit exceeds the risk. Reduce dose if used in patients with moderate hepatic impairment. Liver function tests should be closely monitored. (2.2, 5.1, 8.7, 12.3)
Reduce dose when co-administered with drugs that are moderate or strong CYP3A inhibitors. (2.3, 5.3, 7.2, 12.3)
DOSAGE FORMS AND STRENGTHS
Tablets: fixed dose combination containing elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg.
Co-packaged with:
Tablets: ivacaftor 150 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Elevated liver function tests (ALT, AST or bilirubin): Liver function tests (ALT, AST, and bilirubin) should be assessed prior to initiating TRIKAFTA, every 3 months during the first year of treatment, and annually thereafter. In patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered. Dosing should be interrupted in patients with ALT or AST >5 � upper limit of normal (ULN) or ALT or AST >3 � ULN with bilirubin >2 � ULN. Following resolution of transaminase elevations, consider the benefits and risks of resuming treatment. (5.1, 6)
Use with CYP3A inducers: Concomitant use with strong CYP3A inducers (e.g., rifampin, St. John's wort) significantly decrease ivacaftor exposure and are expected to decrease elexacaftor and tezacaftor exposure, which may reduce TRIKAFTA efficacy. Therefore, co-administration is not recommended. (5.2, 7.1, 12.3)
Cataracts: Non-congenital lens opacities/cataracts have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow-up examinations are recommended in pediatric patients initiating TRIKAFTA treatment. (5.4, 8.4)
ADVERSE REACTIONS
The most common adverse drug reactions to TRIKAFTA (occurring in ?5% of patients and at a frequency higher than placebo by ?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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A inducers: Avoid co-administration. (5.2, 7.1, 12.3)
Strong or moderate CYP3A inhibitors: Reduce TRIKAFTA dosage when co-administered. Avoid food or drink containing grapefruit. (2.3, 5.3, 7.2, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2019
