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Elexacaftor, Ivacaftor, and Tezacaftor

Generic names: lumacaftor, ivacaftor, and tezacaftor E-LEX-aKAF, EYE’V-KAF, and TEXZ-as-KAIF-for 

Brand name :Trikafta.
Form of dosage: oral tablet (100 mg–75 mg–50 mg, 150 mg of ivacaftor 50 mg–37.5 mg–25 mg, and ivacaftor 75 mg)
Drug class: CFTR combinations

What are Elexacaftor, Ivacaftor, and Tezacaftor?

Trikafta is an all-in-one medicine that is used to treat cystic fibrosis in children and adults who are at least 6 years old.Trikafta is only for use in patients who have a specific genetic mutation linked to cystic fibrosis. It is possible that you will require medical tests to make sure that you are carrying the gene mutation.Lumacaftor, ivacaftor, and tezacaftor can be used for other purposes that are not covered in this medication guide.

Side effects of Elexacaftor, Ivacaftor, and Tezacaftor

Contact a medical professional immediately. If you are experiencing symptoms that indicate an allergic reaction, such as symptoms of hives, difficulty breathing, or swelling of your lips, face, and tongue,

Elexacaftor, as well as ivacaftor and tezacaftor, can result in serious adverse reactions. Contact your physician immediately. If you suffer from:

  • Vision changes
  • Problems with the liver: loss of appetite, nausea, stomach discomfort (upper right side), dark urine, and jaundice (yellowing of the eyes or skin).

Common negative effects of lumacaftor, ivacaftor, and tezacaftor can include:

  • Headache;
  • Diarrhea, stomach pain;
  • Rash;
  • Abnormal lab tests;
  • Influenza symptoms like fever, chills, body aches, and chills;
  • Symptoms of the cold, like sinus pain and a stuffy nose sneezing, a stuffy nose, and a sore throat

This isn't a complete list of possible side effects, and other side effects could be present. Consult your physician for advice regarding medical adverse effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

Inform your doctor of all medications you are currently taking. Certain medications should not be used in conjunction with lumacaftor, ivacaftor, or tezacaftor.

Before you take this drug

Certain medications should not be taken with Trikafta. The treatment plan you are using could change when you are also using:

  • Rifabutin or rifampin;
  • John's wort,
  • Seizure medication, such as carbamazepine, phenobarbital, and phenytoin.

Inform your physician immediately if you have ever experienced symptoms associated with:

  • The liver condition
  • Kidney disease.

How to take  Elexacaftor, Ivacaftor, and Tezacaftor?

Follow the directions on the label of your prescription and also read all medication guides or instructions sheets. Be certain to follow all instructions when taking medicine.Trikafta is available as two tablets daily. The typical dosage is two tablets of orange in the morning and one blue tablet at night, twelve hours later. Follow the dosing guidelines of your physician extremely carefully.Suck the tablet completely, and don't crush, chew, or break it.Doses are determined by weight and could alter if your child gains or sheds pounds.The dosage may be altered depending on whether you take other medicines. Your doctor might advise that you take the orange tablet as well as the blue tablet on different days. Don't alter your dosage or dosing schedule unless you have your physician's guidance.Always take ivacaftor, lumacaftor, and tezacaftor along with foods that are high in fat, like peanut butter, eggs, butter and meat, nuts, full milk, cheese, or yogurt. Follow your doctor's dosage instructions extremely carefully.You'll need regular tests of your blood to determine your liver's functioning.Children taking this medicine might require frequent eye examinations to look for cataracts.Place the tablet in a cool, dry place free of heat and moisture. Place each tablet on the blisters that it is in daily until you are in a position for your next dose.

Details on dosage

Usual Adult Dose for Cystic Fibrosis:

Morning dose 2: (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) tablets daily, taken orally.
Evening dosage: 1 (ivacaftor 150 mg) tablet, taken orally in the evening.
Comments:
Doses should be taken around 12 hours apart. Swallow the tablets whole. Tablets are best taken along with fat-rich food items.
If the genotype isn't known, In the event that the genotype is unknown, an FDA-cleared cystic (CF) mutation test must be performed to verify that there is at the very least an F508del variation or one sensitive based on in vitro evidence.
Use: In the treatment of CF in patients with at the very least the F508del variant in cystic fibrosis' transmembrane conductance (CFTR) gene, or an CFTR mutation gene that is responsive to in vitro studies.

Usual Pediatric Dose for Cystic Fibrosis:

Age: 6–12 years; weight: less than 30 kilograms
Morning dose 2. (elexacaftor 50 mg/tezacaftor 25, mg/ivacaftor 37.5 mg) tablets taken orally every morning
Evening dosage: 1 (ivacaftor 75 mg) tablet taken orally every evening.
Age: 6–12 years Weight: 30kg or more
Dosage for the morning: 2 (elexacaftor 100 mg, tezacaftor 100 mg, and ivacaftor 75 mg) tablets taken orally every morning.
Evening dosage: 1 (ivacaftor 150 mg) tablet, taken orally in the evening.
Age 12 years old or more:
Morning dose Two (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) tablets daily, taken orally.
Evening dosage: 1 (ivacaftor 150 mg) tablet, taken orally in the evening.
Comments:
Doses should be taken about 12 hours apart. Swallow the tablets whole. Tablets should be consumed with fat-rich food items.
If the genotype is not known, If the genotype is not known, an FDA-cleared cystic (CF) mutation test must be conducted to determine whether there is at the very least an F508del variation or one dependent on in vitro results.
Use: To treat CF in patients who are six years and older with at least 1 F508del modification in the cystic-fibrosis transmembrane conductance (CFTR) gene or any mutation in the CFTR gene that is responsive based on in vitro evidence.

What happens if I miss the dose?

Do not take the medication as fast as you are able, but make sure you don't take two doses at the same time.When you're over six hours late to taking the tablets in orange, you should take them as quickly as you can. However, avoid the blue tablet for the remainder of the day.If you're more than six hours behind in taking your blue tablet, avoid that missed dose and instead take your orange tablet at your regular time the next day.Take the missed dose when you eat food items containing fat.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help Line toll-free at 1-800-222-1222.

What should be avoided?

Avoid driving or engaging in hazardous activities until you understand the way ivacaftor, lumacaftor, and tezacaftor impact your body. Your reaction may be impaired.Grapefruit could interfere with Trikafta and cause undesirable negative side effects. Do not use products made from grapefruit.

Interaction with other drug

There are times when it's not recommended to take certain medicines simultaneously. Certain drugs may affect the blood levels of other medications that you are taking. This could create side effects or render the medication less effective.

Inform your doctor about all other medications, including:

  • An antibiotic—clarithromycin, erythromycin, telithromycin,
  • Antifungal medicine: fluconazole, ketoconazole, itraconazole, posaconazole, and voriconazole.

This list isn't complete. Other medications could influence Trikafta, such as prescription and over-the-counter medicines, vitamins, and herbal products. There are many possible interactions between drugs that are listed here.