TM Owner Vertex Pharmaceuticals
Symkevi 100mg + 150mg Tablet
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Indications & Clinical Uses
- Symkevi is the EU brand name for the tezacaftor/ivacaftor CFTR modulator combination, marketed in the United States as Symdeko by the same manufacturer, Vertex Pharmaceuticals — the two are the same medicine sold under different regional brand names.
- Symkevi film-coated tablets (tezacaftor 100 mg/ivacaftor 150 mg) are taken each morning together with a separate ivacaftor 150 mg tablet (Kalydeco), taken in the evening; the Symkevi pack itself supplies only the morning combination tablet.
- It is authorised for patients aged 6 years and older with cystic fibrosis who are homozygous for the F508del mutation, or heterozygous for F508del with one of a defined list of other CFTR mutations that respond to tezacaftor/ivacaftor.
- Symkevi is not interchangeable with Kalydeco used alone, Orkambi (lumacaftor/ivacaftor), or Kaftrio (elexacaftor/tezacaftor/ivacaftor), which cover different mutation profiles.
Side Effects
- Very common reactions (10 percent or more of patients) include headache, nasopharyngitis (cold-like symptoms), upper respiratory tract infections, abdominal pain, diarrhoea, rash, and raised liver enzymes on blood tests; common reactions include nausea, sinus congestion, dizziness, and ear pain.
- The EU product information does not use a boxed-warning format, but it carries equally serious warnings that must not be overlooked: cases of liver failure requiring liver transplantation have occurred within the first six months of treatment, even in people with no prior liver disease, and cases of depression, including suicidal ideation, have been reported, usually within the first three months.
- Non-congenital cataracts have been seen in children treated with CFTR modulators.
- Seek urgent medical advice for yellowing skin or eyes, dark urine, or any new low mood or suicidal thoughts.
Precautions & Warnings
- Symkevi is contraindicated in people with a known hypersensitivity to tezacaftor, ivacaftor, or any excipient.
- Liver function tests are required before starting, every three months during the first year, and yearly after that; treatment is interrupted if ALT or AST rises above 5 times the upper limit of normal, or above 3 times with raised bilirubin.
- Mental health, including mood and any suicidal thoughts, should be monitored closely, especially in the first few months and in patients or families with a history of depression.
- Baseline and follow-up eye examinations are recommended in children, because of reported cataracts.
- Use with caution in severe kidney impairment, and Symkevi is not recommended after organ transplantation.
- Symkevi does not require any special storage conditions; take the tablet with fat-containing food each morning.
Avoid Interactions
- Strong CYP3A inhibitors such as ketoconazole and itraconazole significantly raise levels of tezacaftor and ivacaftor, so the Symkevi dose is reduced to twice weekly when combined; moderate inhibitors such as fluconazole or erythromycin require dosing on alternate days instead of daily.
- Strong CYP3A inducers, such as rifampicin, phenobarbital, and St John's Wort, are not recommended because they can substantially reduce Symkevi's effectiveness.
- Grapefruit and grapefruit juice should be avoided, as they can raise drug levels.
- Caution is advised with digoxin and other narrow-therapeutic-index drugs affected by a P-glycoprotein interaction.
- Tell your CF team about all medicines, including hormonal contraceptives and any antidepressants, before starting Symkevi, since combining it with other CYP3A-affecting drugs needs individual dose planning.
References
Frequently Asked Questions
Symkevi (tezacaftor/ivacaftor) treats cystic fibrosis in people aged 6 and older who carry specific CFTR gene mutations, most often two copies of F508del or one copy plus certain other responsive mutations. It helps the faulty CFTR protein work better, improving lung function over time.
Take one Symkevi tablet each morning with fat-containing food. In the evening, take a separate ivacaftor (Kalydeco) tablet, which is not included in the Symkevi pack. Both tablets are needed daily for the combination to work as studied.
More than 1 in 10 people get headache or nasopharyngitis (cold-like symptoms). Symkevi can also raise liver enzymes, and rare cases of liver failure needing a transplant have occurred within the first six months. Get urgent care for yellowing skin or eyes, or dark urine.
Avoid grapefruit and grapefruit juice, which raise drug levels, and strong CYP3A inducers like rifampicin or St John's Wort, which can make Symkevi less effective. Tell your doctor about antifungal medicines, since strong or moderate CYP3A inhibitors need a reduced dosing schedule.
Liver function tests are needed before starting Symkevi, every three months in year one, then yearly. Your care team also watches for mood changes, since depression and suicidal thoughts have been reported, usually within the first three months of treatment. Children may need eye checks for cataracts.
Yes. Symkevi and Symdeko both contain tezacaftor and ivacaftor from Vertex Pharmaceuticals — Symkevi is the brand used in the EU and Ireland, Symdeko the brand used in the US. They are the same medicine marketed under different regional names.
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