Formulary
Lumacaftor with ivacaftor: Indications, Dosing, Side Effects and Interactions
Lumacaftor with ivacaftor clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Lumacaftor with ivacaftor: Indications, Dosing, Side Effects and Interactions
Lumacaftor with ivacaftor clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Cystic fibrosis (specialist use only)**
- **Adult** (By Mouth Using Tablets): 400/250 mg every 12 hours.
**Cystic fibrosis (specialist use only) for lumacaftor with ivacaftor**
- **Child 12-23 months (body-weight 7-8 kg)** (By mouth using granules): 75/94 mg every 12 hours.
- **Child 12-23 months (body-weight 9-13 kg)** (By mouth using granules): 100/125 mg every 12 hours.
- **Child 12-23 months (body-weight 14 kg and above)** (By mouth using granules): 150/188 mg every 12 hours.
- **Child 2-5 years (body-weight up to 14 kg)** (By mouth using granules): 100/125 mg every 12 hours.
- **Child 2-5 years (body-weight 14 kg and above)** (By mouth using granules): 150/188 mg every 12 hours.
- **Child 6-11 years** (By mouth using tablets): 200/250 mg every 12 hours.
- **Child 12-17 years** (By mouth using tablets): 400/250 mg every 12 hours.
Cautions
For lumacaftor with ivacaftor Forced expiratory volume in 1 second (FEV 1 ) less than 40% of the predicted normal value-additional monitoring recommended at initiation of treatment; pulmonary exacerbation-no information available
Side effects
For lumacaftor with ivacaftor Common or very common Breast abnormalities; diarrhoea; dizziness; dyspnoea; ear discomfort; flatulence; gastrointestinal discomfort; headache; increased risk of infection; menstrual cycle irregularities; nasal complaints; nausea; oropharyngeal pain; ototoxicity; productive cough; rash; respiratory disorders; sputum increased; throat erythema; tympanic membrane hyperaemia; vomiting Uncommon Gynaecomastia; hepatic encephalopathy; hepatitis cholestatic; hypertension 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 lumacaftor with ivacaftor Use with caution only if benefit outweighs risk in severe impairment (risk of increased exposure-serious liver injury reported). M Dose adjustments Reduce evening dose to 200/125 mg in moderate impairment; in severe impairment, reduce dose to 200/125 mg every 12 hours or less frequently. 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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