Ivacaftor + lumacaftor
ArticlesLactation Safety InformationNew Medicines · Published , updated
31676711000001102
Articles
18 September 2020
Safety in Lactation: Mucolytics and other drugs for cystic fibrosis
Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. There is no evidence to support… Carbocisteine Dornase alfa Ivacaftor Lumacaftor + Ivacaftor Mannitol Obstetrics and gynaecology Paediatrics and neonates Respiratory disorders Safety in Breastfeeding Sodium chlorideLactation Safety Information
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Very limited published evidence of safety
Small amounts of both components in breast milk probably due to high protein binding
Long half-life of lumacaftor increases risk of accumulation in breastfed infants, although risk is negligible due to small amounts present
15 September 2019
New Medicines
OrkambiCystic fibrosis in homozygous F508del children aged 12 to 23 months
Information
Orkambi
Licence extension / variation
Vertex
Vertex
Development and Regulatory status
None
None
Phase III Clinical Trials
Yes
Yes
Category
Fixed dose combination. A corrector molecule, one of two new classes of ion channel modulators. The corrector modulators enhance the number of channels of the CFTR protein at the cell surface.
CF is the most common inherited disease in white populations. Prevalence is 1 in 2,500 newborn infants, with calculated carrier frequency of 1 in 25. Just over 10,000 people were recorded as having CF in the 2013 UK CF Registry [1].
Cystic fibrosis in homozygous F508del children aged 12 to 23 months
Oral