Formulary
Tezacaftor with ivacaftor: Indications, Dosing, Side Effects and Interactions
Tezacaftor with ivacaftor clinical drug profile including indications, dosing, side effects, cautions and interactions.
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Tezacaftor with ivacaftor: Indications, Dosing, Side Effects and Interactions
Tezacaftor with ivacaftor clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Cystic fibrosis (in combination with ivacaftor) (specialist use only)**
- **Adult** (By Mouth): 100/150 mg, 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) (specialist use only) for tezacaftor with ivacaftor**
- **Child 6-11 years (body-weight up to 30 kg)** (By mouth): 50/75 mg, to be taken in the morning and, Ivacaftor 75 mg to be taken in the evening (about 12 hours apart).
- **Child 6-11 years (body-weight 30 kg and above)** (By mouth): 100/150 mg, 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): 100/150 mg, to be taken in the morning and, Ivacaftor 150 mg to be taken in the evening (about 12 hours apart).
Side effects
For tezacaftor with ivacaftor Common or very common Abdominal pain; breast abnormalities; diarrhoea; dizziness; ear discomfort; headache; increased risk of infection; nasal congestion; nausea; oropharyngeal pain; ototoxicity; rash; sinus congestion; throat erythema; tympanic membrane hyperaemia Uncommon Gynaecomastia Frequency not known Hepatic function abnormal 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 tezacaftor with ivacaftor Use with caution only if benefit outweighs risk in severe impairment (risk of increased exposure-serious liver injury reported). M Dose adjustments Omit evening dose of ivacaftor in moderate or severe impairment; in severe impairment, tezacaftor/ivacaftor should be taken once daily or less frequently, adjust dosing interval according to clinical response and tolerability. M
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**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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