User:Biomedjill/Ivacaftor/elaxacaftor/tezacaftor

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Elexacaftor/tezacaftor/ivacaftor, sold under the brand names Trikafta (US) and Kaftrio (Europe), is a fixed-dose combination medication used in those that have cystic fibrosis with a f508del mutation. It is made up of a combination of elexacaftor, tezacaftor, and ivacaftor.

It was approved for medical use in the United States in 2019. In December 2020, FDA approval was expanded to support an additional 177 mutations. In January 2021, FDA approval was expanded to include children aged 6-11.

In June 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended its approval for the treatment of cystic fibrosis. It was approved for medical use in the European Union in August 2020.

Formulations
Trikafta utilizes a combination tablet containing 100 mg of elexacaftor, 50 mg of tezacaftor, and 75 mg of ivacaftor, and a separate tablet containing 150mg of ivacaftor.

Recommended Dosage
The morning dose is two combination tablets containing elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg. The evening dose is one ivacaftor 150mg tablet.

Side Effects
The most common side effects affecting more than 5% of patients are 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.

Interactions
Concomitant use with CYP3A inducers is not recommended. Dosage must be adjusted with moderate or strong CYP3A inhibitors.

Other drugs with the potential for interaction include: Warfarin, Digoxin, statins, glyburide, nateglinide, repaglinide.