TM Owner Vertex Pharmaceuticals
Symdeko 100mg/150mg + 150mg Tablet
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Indications & Clinical Uses
- Symdeko is a CFTR modulator combination for cystic fibrosis (CF), supplied as a kit of two tablets: a morning tablet combining tezacaftor 100 mg and ivacaftor 150 mg, and a separate evening tablet of ivacaftor 150 mg alone.
- It is approved in the US for patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene, or who have at least one CFTR mutation responsive to tezacaftor/ivacaftor, confirmed by an FDA-cleared genetic test.
- Symdeko is the US brand name; the same combination is marketed in the European Union as Symkevi by the same manufacturer, Vertex Pharmaceuticals — the two are the same medicine under different regional brand names, and Symdeko is not interchangeable with other CFTR modulator combinations such as Kalydeco (ivacaftor alone), Orkambi (lumacaftor/ivacaftor), or Trikafta/Kaftrio (elexacaftor/tezacaftor/ivacaftor), which cover different mutation profiles.
Side Effects
- The most common reactions are headache (about 15 percent), nausea (about 9 percent), sinus congestion, and dizziness (each about 4 percent).
- Symdeko carries no boxed warning, but liver-related reactions, including elevated liver enzymes, are an important risk — rare cases of serious liver injury have been reported, so blood tests to check liver function (ALT and AST) are required before starting, every three months during the first year, and yearly after that; treatment is interrupted if levels rise too high.
- Non-congenital cataracts (clouding of the eye lens) have been reported in children treated with CFTR modulators, so baseline and follow-up eye examinations are recommended in paediatric patients.
- Seek prompt medical attention for yellowing of the skin or eyes, dark urine, severe tiredness, or new vision changes.
Precautions & Warnings
- Symdeko has no listed contraindication, but liver function must be checked regularly as described above, and dosing is interrupted or reduced if abnormalities occur; use with caution in people with pre-existing liver disease.
- A dose reduction is required with moderate or strong CYP3A inhibitors, and Symdeko is not recommended with strong CYP3A inducers, which can make it ineffective.
- Grapefruit and grapefruit juice should be avoided because they can raise drug levels.
- Rare hypersensitivity reactions and neuropsychiatric symptoms such as low mood, sleep disturbance, or dizziness have also been reported; tell your CF team about any new mood changes.
- Symdeko is not approved for CF mutations that do not respond to tezacaftor/ivacaftor — genetic confirmation is required before starting.
- Symdeko is taken by mouth with fat-containing food, morning and evening tablets about 12 hours apart, and the two tablet types must never be combined into a single dose.
Avoid Interactions
- Strong CYP3A inhibitors such as ketoconazole and itraconazole substantially raise tezacaftor and ivacaftor levels, so the Symdeko dose is usually reduced to twice weekly when these are combined; moderate inhibitors such as fluconazole require an alternate-day dosing adjustment.
- Strong CYP3A inducers, including rifampin and St John's Wort, are not recommended because they can make Symdeko much less effective.
- Symdeko can raise digoxin levels through a P-glycoprotein interaction, so extra monitoring is needed with digoxin and other narrow-therapeutic-index drugs.
- Warfarin and other CYP2C9-metabolised drugs, and diabetes medicines like glipizide or glimepiride, may need closer monitoring, including INR checks.
- Grapefruit products should be avoided.
- Tell your CF team about all medicines and supplements, including hormonal contraceptives, before starting Symdeko.
References
Frequently Asked Questions
Symdeko (tezacaftor/ivacaftor) treats cystic fibrosis in people aged 6 and older who are homozygous for the F508del CFTR gene mutation, or who have at least one mutation responsive to this combination, confirmed by a genetic test. It targets the underlying cause of CF rather than just symptoms.
Symdeko is a kit of two tablets. Take the tezacaftor/ivacaftor tablet in the morning with fat-containing food, then the ivacaftor-only tablet about 12 hours later in the evening, also with food. Never combine both tablet types into one dose.
The most common effects are headache, nausea, sinus congestion, and dizziness. Symdeko has no boxed warning, but it can raise liver enzymes, so blood tests are needed regularly. Seek prompt care for yellowing skin or eyes, dark urine, or severe right-sided abdominal pain.
Avoid grapefruit and grapefruit juice, which raise drug levels, and strong CYP3A inducers such as rifampin or St John's Wort, which can make Symdeko ineffective. Tell your doctor about antifungal drugs, since strong or moderate CYP3A inhibitors need a dose adjustment or reduced dosing frequency.
Liver function tests (ALT and AST) are checked before starting Symdeko, every three months during the first year, then yearly after that. Children may also need baseline and follow-up eye exams, since non-congenital cataracts have been reported with CFTR modulators in paediatric patients.
Yes. Symdeko and Symkevi both contain tezacaftor and ivacaftor and are made by Vertex — Symdeko is the US brand name, Symkevi the brand used in the EU and other markets. They are the same medicine sold under different regional names.
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