TRIKAFTA (elexacaftor, tezacaftor and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use.
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.
| Brand Name: | TRIKAFTA |
| Generic Name: | elexacaftor, tezacaftor and ivacaftor tablets |
| Strength: | • Tablets: Fixed-dose combination containing elexacaftor 50 mg, tezacaftor 25 mg and ivacaftor 37.5 mg co-packaged with ivacaftor 75 mg. |
| Manufacturer: | Vertex Pharmaceuticals |
| Approved By: | EMA, USFDA |
Source content : www.accessdata.fda.gov
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