Symdeko

The combination of tezacaftor and ivacaftor facilitates the delivery of and potentiates cystic fibrosis transmembrane conductance regulator (CFTR) protein to the cell surface, which enhances cellular chloride transport.1

The combination of tezacaftor/ivacaftor has the following uses:

The combination of tezacaftor and ivacaftor is 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 CFTR gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.1

If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.1

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

CYP3A inhibitors: Reduce tezacaftor and ivacaftor dose when co-administered with strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A inhibitors. Avoid food containing grapefruit or Seville oranges.1

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

CYP3A inhibitors: Reduce tezacaftor and ivacaftor dose when co-administered with strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A inhibitors. Avoid food containing grapefruit or Seville oranges.1

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Grapefruit and Seville oranges may interact with ivacaftor and tezacaftor and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

Tell your doctor about all your other medicines, especially:

• an antibiotic--clarithromycin, erythromycin, telithromycin; or
• antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may affect ivacaftor and tezacaftor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.