Tezacaftor/Ivacaftor
- TRADE NAME: Symdeko (Vertex)
- INDICATIONS: Cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene
- CLASS: CFTR potentiator (ivacaftor), CFTR protein corrector (tezacaftor)
- HALF-LIFE: 15 hours (tezacaftor); 14 hours (ivacaftor)
FDA APPROVAL DATE: 02/12/2018
CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:Carbamazepine, Clarithromycin, Erythromycin, Fluconazole, Grapefruit Juice, Itraconazole, Ketoconazole, Phenobarbital, Phenytoin, Posaconazole, Rifabutin, Rifampin, Seville oranges, St John's Wort, Strong CY3PA inducers, Strong or moderate CYP3A inhibitors, Telithromycin, Voriconazole
PREGNANCY CATEGORY: N/A
Insufficient evidence to inform drug-associated risk
See also separate profile for ivacaftor.
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MUCOSAL.
CENTRAL NERVOUS SYSTEM.
ENDOCRINE/METABOLIC.
GASTROINTESTINAL/HEPATIC.
NEUROMUSCULAR/SKELETAL.
RESPIRATORY.
OTHER.
Page last updated 07/31/2023
Symbol key
Incidence
- <1%
- 1-5%
- 5-10%
- 10-15%
- 15-20%
- 20-30%
- >30%
Warnings in other populations
- Breast feeding
- Geriatric
- Pediatric