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How do the warnings differ between Symdeko and Orkambi?

Answers (1)

Official Answer by Drugs.com 7 Mar 2018

Orkambi and Symdeko are both medications approved to treat patients with cystic fibrosis.

  • The Orkambi prescribing information contains warnings for an increase in respiratory events such as chest discomfort, shortness of breath, and abnormal breathing during initiation of Orkambi. Symdeko does not contain a warning for an increase in respiratory events.
  • Patients receiving Orkambi who have lower levels of respiration (predicted FEV1 <40) and may require additional monitoring. The Symdeko label does not contain a warning for additional monitoring for respiratory events.
  • The Symdeko label does not state that patients require periodic blood pressure monitoring; however, periodic blood pressure monitoring is recommended in patients taking Orkambi.
  • Both drugs can lead to various levels of liver toxicity, and liver transaminases (AST, ALT) should be assessed prior to initiating treatment, every 3 months during the first year of treatment, and annually thereafter. Review the product labels to determine specifics for prescribing to patients with liver disease or elevated transaminases.
  • Cataracts: for both drugs, non-congenital lens opacities/cataracts have been reported in pediatric patients. Baseline and follow-up examinations are recommended in pediatric patients starting treatment with either Orkambi or Symdeko.
  • Cytochrome P450 3A drug interactions are extensive with each drug and the approved product label should be reviewed. Lumacaftor (an active ingredient found in Orkambi) is a strong inducer of the CYP3A enzymes.
  • According to the Orkambi package insert, hormonal contraceptives (including oral, injectable, transdermal, and implantable) should NOT be relied upon as an effective method of contraception when combined with Orkambi. Their use together is associated with increased menstruation-related side effects. Orkambi may substantially decrease hormonal contraceptive exposure. However, Symdeko, a different agent used to treat certain patients with cystic fibrosis, is not expected to modify the efficacy of hormonal contraceptives.

This is not a complete list of warnings; consult the approved product labels for a full description of the warnings for each drug.

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