Orkambi is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene.If the patient's genotype is unknown, CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.Limitations of UseThe efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.