Deutivacaftor, tezacaftor, vanzacaftor

Deutivacaftor, tezacaftor, vanzacaftor is a combination medicine used to treat cystic fibrosis in adults and children who are at least 6 years old.

deutivacaftor, tezacaftor, vanzacaftor is only for patients who have a specific gene mutation related to cystic fibrosis. You may need a medical test to confirm that you have this gene mutation.

Deutivacaftor, tezacaftor, vanzacaftor may also be used for reasons not mentioned in this medication guide.

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 an eye exam before and after starting this treatment to check for cataracts.

Store at room temperature away from moisture and heat.

This medicine may cause serious liver issues. Stop taking this medicine and contact your doctor immediately if you experience loss of appetite, nausea, vomiting, upper right stomach pain, tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

You should not use this medicine if you are allergic to it.

Tell your doctor if you have or have ever had:

• taken elexacaftor, tezacaftor, or ivacaftor or any other medication; or
• eye problems.
• liver or kidney disease.

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

Deutivacaftor, tezacaftor, vanzacaftor may cause serious side effects. Call your doctor right away if you have:

• blurred vision, seeing halos around lights; or
• 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:

• headache, tiredness, cough;
• rash;
• abnormal liver function tests;
• swelling in the nose or throat;
• pain in the mouth, throat, or nose; or
• flu or 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.

Usual Adult Dose for Cystic Fibrosis:

Vanzacaftor 20 mg-tezacaftor 100 mg-deutivacaftor 250 mg orally once a dayComments:-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 dayWeight at least 40 kg:Vanzacaftor 20 mg-tezacaftor 100 mg-deutivacaftor 250 mg orally once a day12 TO LESS THAN 18 YEARS:Vanzacaftor 20 mg-tezacaftor 100 mg-deutivacaftor 250 mg orally once a dayComments:-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

Take the medicine as soon as you can, with a fatty meal. If you are more than 6 hours late for the dose, skip the missed dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Grapefruit may interact with deutivacaftor, tezacaftor, vanzacaftor and cause side effects.
• Avoid consuming grapefruit products.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the amount of other drugs in your blood, which may lead to more side effects or make the medicines work less effectively.

Other drugs may influence this medicine, including prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all other medicines you are using.