The combination of elexacaftor, tezacaftor, and ivacaftor may cause life-threatening liver damage. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, stop taking the combination of elexacaftor, tezacaftor, and ivacaftor and call your doctor immediately: pain, swelling, or discomfort in the upper right abdominal area, yellowing of your skin or eyes, confusion, dark urine, nausea, vomiting, or loss of appetite.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to the combination of elexacaftor, tezacaftor, and ivacaftor before and during your treatment.
You will be given the Medication Guide when you begin treatment with elexacaftor, tezacaftor, and ivacaftor and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.
Why is this medicine prescribed?
The combination of elexacaftor, tezacaftor, and ivacaftor is used to treat certain types of cystic fibrosis (CF; an inborn disease that causes problems with breathing, digestion, and reproduction). Elexacaftor and tezacaftor are in a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) correctors. Ivacaftor is in a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. These medications work by improving the function of a protein in the body to decrease the build-up of thick mucus in the lungs and improve other CF symptoms.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Elexacaftor, tezacaftor, and ivacaftor come as tablets and as granules to take by mouth. Take with fatty foods twice a day, 12 hours apart. Take elexacaftor, tezacaftor, and ivacaftor at around the same times every day.
Take elexacaftor, tezacaftor, and ivacaftor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking the tablets, each daily dose is usually given as 2 different tablets that have different ingredients. One tablet (combination of elexacaftor, tezacaftor, and ivacaftor) is orange and the other tablet (ivacaftor) is blue. Your doctor will probably tell you to take elexacaftor, tezacaftor, and ivacaftor (2 orange tablets) every morning and ivacaftor (1 blue tablet) every evening.
Swallow the tablets whole; do not split, chew, or crush them.
If you are taking the granules, each daily dose is usually given as 2 different packets of granules: one packet contains granules of elexacaftor, tezacaftor, and ivacaftor and the other packet contains granules of ivacaftor. Your doctor will probably tell you to take 1 packet of elexacaftor, tezacaftor, and ivacaftor granules every morning and 1 packet of ivacaftor granules every evening.
To prepare a dose of elexacaftor, tezacaftor, and ivacaftor granules, mix the entire packet of granules in 1 teaspoon (5 mL) of cold or room temperature soft food or liquid, such as pureed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Take the mixture within 1 hour of mixing the granules with food or a liquid.
Take elexacaftor, tezacaftor, and ivacaftor tablets and granules with fatty foods such as eggs, butter, nuts, peanut butter, cheese pizza, and whole-milk dairy products (such as whole milk, cheese, and yogurt). Talk to your doctor about other fatty foods to eat with these medications.
The combination of elexacaftor, tezacaftor, and ivacaftor works to control cystic fibrosis, but does not cure it. Continue to take these medications even if you feel well. Do not stop taking these medications without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before taking the combination of elexacaftor, tezacaftor, and ivacaftor,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- some medications should not be taken with the combination of elexacaftor, tezacaftor, and ivacaftor. Other medications may cause dosing changes or extra monitoring when taken with the combination of elexacaftor, tezacaftor, and ivacaftor. Make sure you have discussed any medications you are currently taking or plan to take before starting the combination of elexacaftor, tezacaftor, and ivacaftor with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking the combination of elexacaftor, tezacaftor, and ivacaftor, please get the advice of your doctor or pharmacist.
- The following nonprescription or herbal products may interact with elexacaftor, tezacaftor, and ivacaftor: St. John's wort. Be sure to let your healthcare provider know that you are taking this medication before you start taking elexacaftor, tezacaftor, and ivacaftor. Do not start this medication while taking elexacaftor, tezacaftor, and ivacaftor without talking to your healthcare provider.
- tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking the combination of elexacaftor, tezacaftor, and ivacaftor, call your doctor.
What special dietary instructions should I follow?
Do not eat grapefruit or drink grapefruit juice while taking these medications.
What should I do if I forget to take a dose?
If you remember the morning or evening missed dose within 6 hours of the time you were scheduled to take it, take the missed dose right away with a fat-containing food and continue your regular dosing schedule. However, if more than 6 hours have passed since the scheduled time to take your morning dose, take the missed morning dose as soon as possible and skip the evening dose, then continue your regular dosing schedule. If more than 6 hours have passed since the scheduled time to take the evening dose, skip the missed evening dose and continue your regular dosing schedule. Do not take morning and evening doses together to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222
. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
The combination of elexacaftor, tezacaftor, and ivacaftor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- runny nose, sneezing, and stuffiness; fever; cough; or other signs of infection
- diarrhea
- gas
- pink eye
- dizziness
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- rash, itching, hives, difficulty breathing or swallowing
The combination of elexacaftor, tezacaftor, and ivacaftor may cause cataracts (clouding of the lens of the eye that may cause vision problems) in children and teenagers. Children and teenagers taking elexacaftor, tezacaftor, and ivacaftor should see an eye doctor before and during their treatment. Talk to your child's doctor about the risks of giving elexacaftor, tezacaftor, and ivacaftor to your child.
The combination of elexacaftor, tezacaftor, and ivacaftor may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order an eye exam for children and teenagers before and during your treatment.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.