What is the difference between Symdeko and Kalydeco?

Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) are both used to treat patients with cystic fibrosis. The two medicines differ in their ingredients and dosage forms, and the age groups and genetic mutations they treat.

Symdeko is supplied as co-packaged tablets:

• tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg

Kalydeco is supplied as tablets and oral granules:

• ivacaftor 150 mg tablets
• ivacaftor 25 mg oral granules in unit-dose packets
• ivacaftor 50 mg oral granules in unit-dose packets
• ivacaftor 75 mg oral granules in unit-dose packets

Both medicines contain ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator.

Symdeko is approved for the treatment of patients with cystic fibrosis

• aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR gene that is responsive to tezacaftor/ivacaftor.

Kalydeco (ivacaftor) is approved for the treatment patients with cystic fibrosis

• aged 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Both Symdeko and Kalydeco are manufactured by Vertex Pharmaceuticals.