TM Owner Vertex Pharmaceuticals
Kaftrio 75mg + 50mg + 100mg Tablet
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Indications & Clinical Uses
- Kaftrio film-coated tablets contain ivacaftor 75 mg, tezacaftor 50 mg and elexacaftor 100 mg (labelled as Kaftrio 75 mg/50 mg/100 mg), three CFTR modulators that help the faulty CFTR protein reach the cell surface and open properly.
- Kaftrio treats cystic fibrosis in people aged 6 years and over who have at least one F508del mutation in the CFTR gene; granules in sachets are used for children aged 2 to 5 years.
- It is always taken together with a separate ivacaftor 150 mg tablet in the evening, so a full day is two Kaftrio tablets in the morning and one ivacaftor tablet about 12 hours later.
- Kaftrio is the European brand name; the identical elexacaftor/tezacaftor/ivacaftor combination is marketed in the United States as Trikafta, co-packaged with ivacaftor in a single carton.
- Treatment is long term and supervised by a cystic fibrosis specialist centre.
Side Effects
- The most common Kaftrio side effects are headache (about 17 in 100 people), diarrhoea (about 13 in 100), upper respiratory tract infection (about 12 in 100), raised liver enzymes (about 11 in 100), blocked or runny nose, abdominal pain, dizziness and rash; rash is very common and occurs more often in women, particularly those using hormonal contraception.
- Kaftrio has no boxed warning, but serious liver injury has been reported, including liver failure requiring transplantation, mostly within the first six months.
- Effects on mood and behaviour such as anxiety, depression, sleep disturbance and forgetfulness have been reported, usually within three months of starting.
- Seek urgent advice for yellowing of the skin or eyes, dark urine, pale stools, persistent nausea or vomiting, right-sided tummy pain, confusion, or thoughts of harming yourself.
- Non-congenital lens opacities (cataracts) have been seen in children taking these medicines.
Precautions & Warnings
- Liver blood tests (ALT, AST and bilirubin) are needed before starting Kaftrio, every three months during the first year, then yearly, and more often if you have had liver disease; treatment is interrupted if ALT or AST rise above five times the upper limit of normal, or above three times normal together with bilirubin more than twice normal.
- Children starting treatment should have eye examinations before and during therapy to look for lens opacities.
- The dose is reduced in moderate hepatic impairment and Kaftrio is not recommended in severe liver disease.
- Tell your team about any organ transplant or mood disorder.
- Kaftrio is preferably avoided during pregnancy, and breastfeeding should be discussed with your specialist because it is unknown whether the active substances pass into milk.
- Tablets are swallowed whole, never chewed or crushed, in the morning with fat-containing food such as eggs, butter, cheese, nuts or whole-milk products.
Avoid Interactions
- Kaftrio levels are increased by moderate and strong CYP3A inhibitors including itraconazole, ketoconazole, voriconazole, posaconazole, clarithromycin, erythromycin, telithromycin, fluconazole and verapamil, and by grapefruit and Seville oranges, which must be avoided in all food and drink; when such an inhibitor is needed, the dose and schedule of Kaftrio and of the evening ivacaftor tablet are reduced.
- Kaftrio levels are lowered, with loss of effect, by strong CYP3A inducers such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St John's wort, and these combinations are not recommended.
- Kaftrio may raise levels of sensitive CYP3A and P-glycoprotein substrates including midazolam, digoxin, ciclosporin, tacrolimus, sirolimus and everolimus.
- Rash occurs more often in women taking hormonal contraceptives, although contraceptive efficacy is not expected to change.
- Tell your specialist about every medicine, herbal remedy and supplement before starting.
References
Frequently Asked Questions
Kaftrio (ivacaftor, tezacaftor and elexacaftor) treats cystic fibrosis in people aged 6 years and over who have at least one F508del mutation in the CFTR gene. It helps the faulty CFTR protein work better. The same three-drug combination is sold in the United States as Trikafta.
Take two Kaftrio 75/50/100 mg tablets each morning and one separate ivacaftor 150 mg tablet in the evening, about 12 hours apart. Swallow them whole with fat-containing food such as eggs, butter, cheese or whole milk, which greatly increases how much medicine your body absorbs.
Common Kaftrio side effects are headache, diarrhoea, colds and other upper airway infections, stomach pain, dizziness and rash. Liver enzymes rise in about 1 in 10 people. Get urgent help for yellow skin or eyes, dark urine, right-sided tummy pain, or new depression or suicidal thoughts.
Avoid grapefruit and Seville oranges completely while taking Kaftrio, as they raise drug levels. Strong CYP3A inducers such as rifampicin, carbamazepine, phenytoin and St John's wort make elexacaftor/tezacaftor/ivacaftor much less effective and are not recommended. Antifungals and some antibiotics need a reduced Kaftrio dose.
Kaftrio needs liver blood tests (ALT, AST and bilirubin) before you start, every three months for the first year, then once a year. Treatment is paused if enzymes rise above five times normal. Children also have eye checks for lens opacities before and during treatment.
Kaftrio is preferably avoided during pregnancy unless your specialist decides the benefit outweighs the risk. It is not known whether ivacaftor, tezacaftor or elexacaftor pass into breast milk, so breastfeeding needs a careful discussion. Rash is more common in women using hormonal contraception, though contraception still works normally.
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