Deutivacaftor, tezacaftor, vanzacaftor
Generic name: deutivacaftor, tezacaftor, vanzacaftor
Brand name: Alyftrek
Dosage form: oral tablet (125 mg-50 mg-10 mg; 50 mg-20 mg-4 mg)
Drug class: CFTR combinations
What is deutivacaftor, tezacaftor, vanzacaftor?
Deutivacaftor, tezacaftor, vanzacaftor is a combination medicine used to treat cystic fibrosis in adults and children at least 6 years old.
deutivacaftor, tezacaftor, vanzacaftor 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.
Deutivacaftor, tezacaftor, vanzacaftor may also be used for purposes not listed in this medication guide.
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.
Deutivacaftor, tezacaftor, vanzacaftor may cause serious side effects. Call your doctor at once if you have:
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blurred vision, seeing halos around lights; or
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liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects of deutivacaftor, tezacaftor, vanzacaftor may include:
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rash;
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abnormal liver function tests;
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nose or throat swelling;
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mouth, throat, or nose pain; or
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flu, cold symptoms such as stuffy nose, 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.
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Warnings
This medicine may cause severe liver problems. Stop taking this medicine and call your doctor right away if you have loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Before taking this medicine
You should not use this medicine if you are allergic to it.
Tell your doctor if you have or have ever had:
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taken elexacaftor, tezacaftor, or ivacaftor or any other medication; or
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eye problems.
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liver or kidney disease.
How should I take deutivacaftor, tezacaftor, vanzacaftor?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
You may need to take 2 or 3 tablets to receive your full dose. Take the medicine at the same time each day.
Always take this medicine with food that contains fat, such as butter, peanut butter, eggs, nuts, meat, whole milk, cheese, or yogurt. Follow your doctor's instructions carefully.
Swallow the tablet whole and do not crush, chew, or break it.
Doses are based on weight in children and teenagers less than 12 years old. The dose may change if the child gains or loses weight.
Your dose may change if you also take certain other medications. Do not change your dose or dosing schedule without your doctor's advice.
You will need frequent blood tests to check your liver function.
You may also need other medical tests such as eye exam before and after starting this treatment to check for cataracts.
Store at room temperature away from moisture and heat.
Deutivacaftor, tezacaftor, vanzacaftor dosing information
Usual Adult Dose for Cystic Fibrosis:
Vanzacaftor 20 mg-tezacaftor 100 mg-deutivacaftor 250 mg orally once a day
Comments:
-Confirm the presence of at least 1 indicated mutation with an FDA-cleared cystic fibrosis (CF) mutation test if the patient's genotype is unknown.
Use: For the treatment of cystic fibrosis in patients who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Usual Pediatric Dose for Cystic Fibrosis:
6 TO LESS THAN 12 YEARS:
Weight less than 40 kg:
Vanzacaftor 12 mg-tezacaftor 60 mg-deutivacaftor 150 mg orally once a day
Weight at least 40 kg:
Vanzacaftor 20 mg-tezacaftor 100 mg-deutivacaftor 250 mg orally once a day
12 YEARS AND OLDER:
Vanzacaftor 20 mg-tezacaftor 100 mg-deutivacaftor 250 mg orally once a day
Comments:
-Confirm the presence of at least 1 indicated mutation with an FDA-cleared CF mutation test if the patient's genotype is unknown.
Use: For the treatment of cystic fibrosis in patients who have at least one F508del mutation or another responsive mutation in the CFTR gene
What happens if I miss a dose?
Take the medicine as soon as you can, with a fatty meal, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking deutivacaftor, tezacaftor, vanzacaftor?
Grapefruit may interact with deutivacaftor, tezacaftor, vanzacaftor and cause side effects. Avoid consuming grapefruit products.
What other drugs will affect deutivacaftor, tezacaftor, vanzacaftor?
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
More about deutivacaftor / tezacaftor / vanzacaftor
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- Dosage information
- Drug class: CFTR combinations
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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