FDA Approves Vertex’s Symdeko (tezacaftor/ivacaftor) Tablets For The Treatment Of Cystic Fibrosis
Dosage Form: Tablet
Specific Treatments: cystic fibrosis
Therapeutic Areas: Pulmonary/Respiratory Diseases
General information about Symdeko
Symdeko is a combination of tezacaftor and ivacaftor. Tezacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) corrector. Ivacaftor is a CFTR potentiator.
Symdeko is specifically indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
Symdeko is supplied as a tablet for oral administration. The recommended dose is one tablet (tezacaftor 100 mg/ivacaftor 150 mg) taken in the morning and one tablet (ivacaftor 150 mg) taken in the evening, approximately 12 hours apart. The tablets should be swallowed whole. Symdeko should be taken with fat-containing food. See drug label for dose adjustments in patients with hepatic impairment and for co-administration with moderate inhibitors of CYP3A.