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Elexacaftor, Tezacaftor, and Ivacaftor

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Why is this medication prescribed?

Certain kinds of cystic fibrosis (an inborn condition that affects breathing, digestion, and reproduction) are treated in adults and children 6 years of age and older with elexacaftor, tezacaftor, and ivacaftor. Only those with a particular genetic make-up ought to utilize it. To determine whether this drug is right for you, your doctor may request a blood test. The drugs elexacaftor and tezacaftor belong to a group of drugs known as CFTR correctors (cystic fibrosis transmembrane conductance regulator) correctors. Ivacaftor belongs to a group of drugs known as cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. These drugs lessen the accumulation of thick mucus in the lungs and alleviate other cystic fibrosis symptoms by enhancing the action of a protein in the body.

How should this medicine be used?

Elexacaftor, Tezacaftor, and Ivacaftor are available as oral tablet form. A distinct type of tablet is used for each daily dose: one tablet contains the ingredients elexacaftor, tezacaftor, and ivacaftor, and the other tablet just contains ivacaftor. Take two orange tablets of elexacaftor, tezacaftor, and ivacaftor every morning with a fatty food and one blue tablet of ivacaftor every evening with a fatty food, separated by 12 hours. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the directions on the prescription exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Take elexacaftor, tezacaftor, and ivacaftor along with fatty foods like eggs, butter, nuts, pizza with cheese, and dairy products made with whole milk (such cheese and yogurt). Discuss additional fatty meals to eat with these drugs with your doctor.

Cystic fibrosis can be controlled with the help of elexacaftor, tezacaftor, and ivacaftor but is not curable. Even if you feel well, keep taking these meds. Without consulting your doctor, do not discontinue using these medications.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking the combination of elexacaftor, tezacaftor, and ivacaftor,

  • If you have an allergy to elexacaftor, tezacaftor, or ivacaftor, any other medications, or any of the substances in elexacaftor, tezacaftor, or ivacaftor tablets, notify your doctor and pharmacist right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, or dietary supplements you are currently taking or intend to take. Incorporate any of the following: a few antibiotics, as erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), clarithromycin (Biaxin, in PrevPac); some antifungal medications, including voriconazole (Vfend), itraconazole (Onmel), ketoconazole, posaconazole (Noxafil), and itraconazole (Diflucan); cyclosporine (Gengraf, Neoral, Sandimmune); statins such as atorvastatin (Lipitor, in Caduet); fluvastatin (Lescol); lovastatin (Altoprev); pravastatin (Pravachol); rosuvastatin (Crestor); and simvastatin (Zocor, in Vytorin); hormonal contraceptives (birth control pills, patches, rings, implants, or injections); digoxin (Lanoxin); everolimus (Afinitor, Zortress); glimepiride (Amaryl); glipizide (Glucotrol); glyburide (Diabeta); some seizure drugs, including phenobarbital, phenytoin, and carbamazepine (Carbatrol, Epitol, Tegretol, and others); rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); sirolimus (Rapamune); tacrolimus (Astagraf, Prograf); or warfarin (Coumadin, Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Elexacaftor, tezacaftor, and ivacaftor may interact with a wide range of other drugs, so it’s important to let your doctor know about all the drugs you’re taking even those that aren’t on this list.
  • In particular, mention St. John’s wort to your doctor when you use any herbal remedies. While taking the tri-drug regimen of elexacaftor, tezacaftor, and ivacaftor, your doctor generally won’t advise you to take St. John’s wort.
  • Inform your physician if you now have or have ever had renal or liver illness.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while taking elexacaftor, tezacaftor, and ivacaftor.
  • You should be aware that these drugs might cause you to feel sleepy. Until you are certain of how these medications will effect you, avoid using machinery or driving a car.

What special dietary instructions should I follow?

When consuming these drugs, avoid eating or drinking grapefruit.

What should I do if I forget a dose?

Take the missed dose straight away with a fat-containing food and carry on with your regular dosing plan if you remember about the morning or evening dose within six hours of the time you were supposed to take it. However, if it has been more than 6 hours since your morning dose was supposed to be taken, skip the evening dose and take your missing morning dose right away. Then, carry on with your regular dosing plan. If the time for the evening dose was more than 6 hours ago, omit the missed dose and carry on with your regular dosing plan. Never combine your morning and evening dosages to make up for a missing one.

What side effects can this medication cause?

There may be negative effects from taking elexacaftor, tezacaftor, and ivacaftor together. If any of these symptoms are severe or do not go away, consult your doctor:

  • Headache
  • Fever, cough, runny or stuffy nose, sneezing, or other infection-related symptoms
  • Stomach discomfort or bloating
  • Diarrhea
  • Rash
  • Gas
  • Red eye
  • Itching

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

  • Eyes or skin that have a yellow tint
  • Reduced appetite
  • Nausea
  • Vomiting
  • Light stools
  • Abdominal pain
  • Dark feces

In children and teenagers, the combination of elexacaftor, tezacaftor, and ivacaftor may result in cataracts (clouding of the lens of the eye that may result in vision issues). Before and during their treatment with elexacaftor, tezacaftor, or ivacaftor, children and teenagers should visit an eye doctor. The hazards of administering your child elexacaftor, tezacaftor, and ivacaftor should be discussed with your child’s physician.

Other negative effects could result from taking elexacaftor, tezacaftor, and ivacaftor together. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. Before and during your treatment, your doctor may prescribe specific lab tests, such as liver tests, to monitor how your body is responding to elexacaftor, tezacaftor, and ivacaftor. An eye exam (for kids and teenagers) is also recommended.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Trikafta®
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