Ivacaftor + lumacaftor

ArticlesLactation Safety InformationNew Medicines ·
31676711000001102

Articles

Lactation 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

Evidence based evaluations