Elexacaftor, ivacaftor, and tezacaftor

Generic name: Elexacaftor, Ivacaftor, And Tezacaftor
Brand names: Trikafta
Dosage form: oral tablet (100 mg-75 mg-50 mg and ivacaftor 150 mg; 50 mg-37.5 mg-25 mg and ivacaftor 75 mg)
Drug class: CFTR combinations

Usage of Elexacaftor, ivacaftor, and tezacaftor

Trikafta is a combination medicine used to treat cystic fibrosis in adults and children at least 6 years old.

Trikafta is for use only in patients with a specific gene mUTAtion related to cystic fibrosis. You may need a medical test to make sure you have this gene mutation.

Elexacaftor, ivacaftor, and tezacaftor may also be used for purposes not listed in this medication guide.

Elexacaftor, ivacaftor, and tezacaftor side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Elexacaftor, ivacaftor, and tezacaftor may cause serious side effects. Call your doctor at once if you have:

vision changes; or

liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of elexacaftor, ivacaftor, and tezacaftor may include:

headache;

diarrhea, stomach pain;

rash;

abnormal lab tests;

flu symptoms such as fever, chills, body aches; or

cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Elexacaftor, ivacaftor, and tezacaftor

Some drugs should not be used with Trikafta. Your treatment plan may change if you also use:

rifabutin or rifampin;

St. John's wort; or

seizure medicine such as Carbamazepine, phenobarbital, or phenytoin.

Tell your doctor if you have ever had:

liver disease; or

kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Relate drugs

How to use Elexacaftor, ivacaftor, and tezacaftor

Usual Adult Dose for Cystic Fibrosis:

Morning dose: 2 (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) tablets orally each morningEvening dose: 1 (ivacaftor 150 mg) tablet orally each eveningComments: -Doses should be taken approximately 12 hours apart; swallow tablets whole; tablets should be taken with fat-containing food.-If genotype is unknown, an FDA-cleared cystic fibrosis (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.Use: For the treatment of CF in patients 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.

Usual Pediatric Dose for Cystic Fibrosis:

Age: 6 to 12 years; weight: Less than 30 kg: -Morning dose: 2 (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg) tablets orally each morning-Evening dose: 1 (ivacaftor 75 mg) tablet orally each eveningAge: 6 to 12 years; weight: 30 kg or more: -Morning dose: 2 (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) tablets orally each morning-Evening dose: 1 (ivacaftor 150 mg) tablet orally each eveningAge: 12 years or older: Morning dose: 2 (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) tablets orally each morningEvening dose: 1 (ivacaftor 150 mg) tablet orally each eveningComments: -Doses should be taken approximately 12 hours apart; swallow tablets whole; tablets should be taken with fat-containing food.-If genotype is unknown, an FDA-cleared cystic fibrosis (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.Use: For the treatment of CF in patients aged 6 years or 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.

Warnings

Tell your doctor about all your other medicines. Some drugs should not be used with elexacaftor, ivacaftor, and tezacaftor.

What other drugs will affect Elexacaftor, ivacaftor, and tezacaftor

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

an antibiotic--clarithromycin, erythromycin, Telithromycin; or

antifungal medicine--fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may affect Trikafta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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