TREATMENT ELIGIBILITY

ARE YOUR PATIENTS ELIGIBLE FOR
TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)?

Enter your patient's mutations below to see if they are eligible for TRIKAFTA.
You may determine eligibility for up to 5 patients at once.

Enter your patient’s mutations below to see if they are eligible for TRIKAFTA.

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data.

Mutation 1 Mutation 2 Results

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Please see most common responsive mutations below.

Most Common Responsive Mutations^1,2

Indicated based on clinical data
F508del

Other indicated mutations based on in vitro data^1,2,a

G551D | R117H | D1152H | G85E
L206W | R347P | A455E

170 less common mutations are also eligible.

Most Common Responsive Mutations^1,2

Indicated based on clinical data
F508del

Other indicated mutations based on in vitro data^1,2,a

G551D | R117H | D1152H | G85E
L206W | R347P | A455E

170 less common mutations are also eligible.

Mutations were considered responsive if CFTR activity resulted in a net increase of ≥10% over baseline after adding elexacaftor/tezacaftor/ivacaftor.¹

^aThese mutations are present in ≥0.6% of individuals with CF.²

See the Trial 1 results

See the safety profile of TRIKAFTA

Indications and Usage

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data.

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 or a mutation that is responsive based on in vitro data.

Important Safety Information

Liver Function Test Elevations

Elevated transaminases have been observed in patients with CF treated with TRIKAFTA. Bilirubin elevations have also been observed with TRIKAFTA treatment. Assessments of liver function tests (ALT, AST, and bilirubin) are recommended prior to initiating TRIKAFTA, every 3 months during the first year of treatment, and annually thereafter

In the event of significant elevations in liver function tests, e.g. 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. Following the resolution of liver function test elevations, consider the benefits and risks of resuming treatment

For patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered

Concomitant Use With CYP3A Inducers

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. Co‑administration with strong CYP3A inducers is not recommended

Concomitant Use With CYP3A Inhibitors

Exposure to elexacaftor, tezacaftor, and ivacaftor are increased when co-administered with strong or moderate CYP3A inhibitors. The dose of TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors

Cataracts

Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA

Pediatric Use

The safety and effectiveness efficacy of TRIKAFTA in patients with CF younger than 6 years of age have not been established

Serious Adverse Reactions

Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs <1%) and influenza (1% vs 0)

Most Common Adverse Reactions

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
The safety profile for the patients receiving TRIKAFTA (N=55) in the 4-week, randomized, double-blind, active-controlled Phase 3 trial (Trial 2) was similar to that observed in Trial 1
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 older

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