SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of patients with cystic fibrosis (CF) age 6 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.

Clinical considerations are based on drug interaction studies, modeling, other clinical factors, and/or predicted interactions due to elimination pathways.

Drugs shown within a therapeutic class do not represent all possible drugs within the class. Drugs within a class may have different metabolic profiles, and therefore, clinical recommendations apply only to the drugs named and not the class. The table does not represent all possible drugs or drug classes that a patient could be receiving.

Potential drug interactions with SYMDEKO

STRONG CYP3A Inducers1

Examples
  • Rifampina
  • Rifabutin
  • Phenobarbital
  • Carbamazepine
  • Phenytoin
  • St. John’s wort (Hypericum perforatum)
Effect
  • Reduced blood levels of SYMDEKO are expected, potentially resulting in reduced efficacy
Clinical Recommendation
  • Concomitant use is not recommended

STRONG CYP3A Inhibitors1

Examples
  • Ketoconazole
  • Itraconazoleb
  • Posaconazole
  • Voriconazole
  • Telithromycin
  • Clarithromycin
Effect
  • Increased blood levels of SYMDEKO are expected
Clinical Recommendation
  • SYMDEKO dosing adjustment is recommended
For full dosing table, click here.

MODERATE CYP3A Inhibitors1

Examples
  • Fluconazolec
  • Erythromycin
Effect
  • Increased blood levels of SYMDEKO are expected
Clinical Recommendation
  • SYMDEKO dosing adjustment is recommended
For full dosing table, click here.
Examples
Food/Drink1
  • Grapefruit
  • Seville oranges
Effect
  • Increased blood levels of SYMDEKO are expected
Clinical Recommendation
  • Avoid during treatment with SYMDEKO
For full dosing table, click here.

CYP2C9 Substrates1,2,3

Examples
  • Warfarin
Effect
  • Ivacaftor may inhibit CYP2C9 and increase exposures of these drugs
Clinical Recommendation
  • Monitor international normalized ratio

P-gp Substrates1,2,3

Examples
  • Digoxin
  • Cyclosporine
  • Everolimus
  • Sirolimus
  • Tacrolimus
Effect
  • SYMDEKO increased digoxin exposure and may increase exposure of other sensitive P-gp substrates
Clinical Recommendation
  • Caution and appropriate monitoring of these drugs should be used
  1. Co-administration of ivacaftor with rifampin, a strong CYP3A inducer, significantly decreased ivacaftor exposure (AUC) by 89%; tezacaftor exposures can also be expected to decrease significantly.1
  2. Co-administration with itraconazole, a strong CYP3A inhibitor, increased tezacaftor exposure (AUC) by 4.0-fold and ivacaftor by 15.6-fold.1
  3. Co-administration with fluconazole, a moderate CYP3A inhibitor, increased ivacaftor exposure (AUC) by approximately 3.0-fold, and may increase tezacaftor exposure by approximately 2.0-fold.1

AUC, area under the curve.

Drugs not expected to have a clinically significant effect on SYMDEKO or vice versa

Drugs not requiring dose adjustments1,2,3

Examples
  • Oral contraceptives (ethinyl estradiol / norethindrone)
  • Specific antidepressants (desipramine, citalopram, escitalopram, sertraline, mirtazapine, paroxetine, trazodone)
  • Azithromycin
  • CYP3A substrates (e.g., midazolam [oral])
  • Ciprofloxacin

Drug-Drug Interaction Tool

The drug-drug interaction (DDI) tool provides the established or predicted effect of SYMDEKO on other medicinal products or effect of other medicinal products on SYMDEKO1,2

  • Clinical considerations are based on drug interaction studies, modeling, other clinical factors, and/or predicted interactions due to elimination pathways

  • Drugs shown within a therapeutic class do not represent all possible drugs within the class. Drugs within a class may have different metabolic profiles, and therefore, clinical recommendations apply only to the named drugs and not the class. The table does not represent all possible drugs or drug classes that a patient could be receiving. For further information, contact your clinical pharmacist

Choose or begin typing the brand or generic drug name or drug class to learn more about potential DDIs

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Drug names in the table that are bold are listed in the full Prescribing Information for SYMDEKO.