Formulary
Ivacaftor with tezacaftor and elexacaftor: Indications, Dosing, Side Effects and Interactions
Ivacaftor with tezacaftor and elexacaftor clinical drug profile including indications, dosing, side effects, cautions and interactions.
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Ivacaftor with tezacaftor and elexacaftor: Indications, Dosing, Side Effects and Interactions
Ivacaftor with tezacaftor and elexacaftor clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Cystic fibrosis (in combination with ivacaftor) [using tablets containing 75/50/100 mg ivacaftor/tezacaftor/elexacaftor] (specialist use only)**
- **Adult** (By Mouth): 2 tablets, to be taken in the morning and, Ivacaftor 150 mg to be taken in the evening (about 12 hours apart).
**Cystic fibrosis (in combination with ivacaftor) [using tablets containing 37.5/25/50 mg ivacaftor/tezacaftor/elexacaftor] (specialist use only) for ivacaftor with tezacaftor and elexacaftor**
- **Child 6-11 years (body-weight up to 30 kg)** (By mouth): 2 tablets, to be taken in the morning and, Ivacaftor 75 mg to be taken in the evening (about 12 hours apart).
**Cystic fibrosis (in combination with ivacaftor) [using tablets containing 75/50/100 mg ivacaftor/tezacaftor/elexacaftor] (specialist use only) for ivacaftor with tezacaftor and elexacaftor**
- **Child 6-11 years (body-weight 30 kg and above)** (By mouth): 2 tablets, to be taken in the morning and, Ivacaftor 150 mg to be taken in the evening (about 12 hours apart).
- **Child 12-17 years** (By mouth): 2 tablets, to be taken in the morning and, Ivacaftor 150 mg to be taken in the evening (about 12 hours apart).
**Cystic fibrosis (in combination with ivacaftor) [using granules containing 60/40/80 mg ivacaftor/tezacaftor/elexacaftor] (specialist use only) for ivacaftor with tezacaftor and elexacaftor**
- **Child 2-5 years (body-weight up to 14 kg)** (By mouth): 1 sachet, to be taken in the morning and, Ivacaftor 59.5 mg sachet to be taken in the evening (about 12 hours apart).
**Cystic fibrosis (in combination with ivacaftor) [using granules containing 75/50/100 mg ivacaftor/tezacaftor/elexacaftor] (specialist use only) for ivacaftor with tezacaftor and elexacaftor**
- **Child 2-5 years (body-weight 14 kg and above)** (By mouth): 1 sachet, to be taken in the morning and, Ivacaftor 75 mg sachet to be taken in the evening (about 12 hours apart).
Side effects
For ivacaftor with tezacaftor and elexacaftor Common or very common Breast abnormalities; diarrhoea; dizziness; ear discomfort; flatulence; gastrointestinal discomfort; headache; hypoglycaemia; increased risk of infection; nasal complaints; nausea; oropharyngeal pain; ototoxicity; respiratory disorders; skin reactions; throat erythema; tympanic membrane hyperaemia Uncommon Gynaecomastia Frequency not known Anxiety; concentration impaired; depressed mood; liver injury; memory impairment; mood altered; sleep disorder Side-effects, further information Manufacturer advises interrupt treatment if transaminase levels more than 5 times the upper limit of normal or transaminase levels more than 3 times the upper limit of normal and blood bilirubin more than twice the upper limit of normal-consult product literature.
Hepatic impairment
For ivacaftor with tezacaftor and elexacaftor Avoid in severe impairment; use with caution only if benefit outweighs risk in moderate impairment (risk of increased exposure-serious liver injury reported). M Dose adjustments In moderate impairment, alternate dose between 1 and 2 tablets in the mornings, and omit evening dose of ivacaftor. M
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Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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