Deutivacaftor, Tezacaftor, Vanzacaftor (Oral)
Deutivacaftor, tezacaftor, vanzacaftor is a combination medicine used to treat cystic fibrosis in adults and children at least 6 years old.
This medicine 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.
uses
What is Deutivacaftor, Tezacaftor, Vanzacaftor (Oral) used for?
- Pulmonary Impairment
- Cystic Fibrosis
- Cystic Fibrosis with Ileus
warnings
What is the most important information I should know about Deutivacaftor, Tezacaftor, Vanzacaftor (Oral)?
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.
Side Effects
What are the side effects of Deutivacaftor, Tezacaftor, Vanzacaftor (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once 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 may include:
- headache, tiredness, cough;
- rash;
- abnormal liver function tests;
- nose or throat swelling;
- mouth, throat, or nose pain; or
- 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.
Interactions
What drugs and food should I avoid while taking Deutivacaftor, Tezacaftor, Vanzacaftor (Oral)?
Grapefruit may interact with deutivacaftor, tezacaftor, vanzacaftor and cause side effects. Avoid consuming grapefruit products.
Dosage Guidelines & Tips
How to take Deutivacaftor, Tezacaftor, Vanzacaftor (Oral)?
Use Deutivacaftor, Tezacaftor, Vanzacaftor (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
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.
Overdose Signs
What happens if I overdose on Deutivacaftor, Tezacaftor, Vanzacaftor (Oral)?
Images
V4
Color: purple
Shape: round
Form: film coated
Imprint: V4
V10
Color: purple
Shape: oblong
Form: film coated
Imprint: V10