Ivacaftor for Cystic Fibrosis and the G551D-CFTR Mutation
The adverse effects of ivacaftor were assessed in a total of 353 adult and pediatric subjects with CF taking part in clinical trials. The most commonly reported reactions in the pooled data were headache (in 17% of patients), upper respiratory tract infection (16%), nasal congestion (16%), nausea (10%), rash (10%), rhinitis (6%), dizziness (5%), arthralgia (5%), and bacteria in sputum (5%). Other adverse effects reported at rates greater than placebo included oropharyngeal pain (24%), abdominal pain (16%), and diarrhea (13%).
In the pooled clinical trial data, 2% of subjects receiving ivacaftor discontinued treatment because of adverse effects compared to 5% of` subjects receiving placebo. Serious adverse effects reported with ivacaftor have included pulmonary exacerbations, hemoptysis, increased serum transaminases, abdominal pain, and hypoglycemia or hyperglycemia.
Adverse Effects
The adverse effects of ivacaftor were assessed in a total of 353 adult and pediatric subjects with CF taking part in clinical trials. The most commonly reported reactions in the pooled data were headache (in 17% of patients), upper respiratory tract infection (16%), nasal congestion (16%), nausea (10%), rash (10%), rhinitis (6%), dizziness (5%), arthralgia (5%), and bacteria in sputum (5%). Other adverse effects reported at rates greater than placebo included oropharyngeal pain (24%), abdominal pain (16%), and diarrhea (13%).
In the pooled clinical trial data, 2% of subjects receiving ivacaftor discontinued treatment because of adverse effects compared to 5% of` subjects receiving placebo. Serious adverse effects reported with ivacaftor have included pulmonary exacerbations, hemoptysis, increased serum transaminases, abdominal pain, and hypoglycemia or hyperglycemia.
SHARE
