Tezacaftor/Ivacaftor

BreastfeedingPediatric
  • 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.

Our database has 14 adverse reactions for this drug across the following areas

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MUCOSAL
CENTRAL NERVOUS SYSTEM
NEUROMUSCULAR/SKELETAL
GASTROINTESTINAL/HEPATIC
RESPIRATORY
ENDOCRINE/METABOLIC


Page last updated 09/19/2018

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Incidence info

  • <1%
  • 1-5%
  • 5-10%
  • 10-15%
  • 15-20%
  • 20-30%
  • >30%

Seriousness info

  • Hospitalization possible
  • Life threatening
  • Fatal

Warnings in other populations info

  • Breast feeding
  • Geriatric
  • Pediatric