Renal Dose Adjustment
- Mild-moderate impairment: No dose adjustments
- Severe impairment or ESRD: Dose adjustments not defined; caution advised
Hepatic impairment
- Mild impairment (Child-Pugh Class A): No dose adjustments
- Moderate impairment (Child-Pugh Class B): Dose reduced to 150 mg PO q day
- Severe impairment (Child-Pugh Class C): 150 mg once daily or less frequently
Co-administration with CYP3A Inhibitors
- With strong CYP3A inhibitors: Dose reduced to 150 mg twice-a-week
- With moderate CYP3A inhibitors: Dose reduced to 150 mg once daily
Note:
- Food containing grapefruit or Seville oranges should be avoided
See Supplemental Patient Information
- Patients with CF may experience elevated transaminases levels. Monitor ALT and AST prior to initiating therapy, every 3 months during the first year of treatment, and annually thereafter. Closely monitor patients until abnormalities resolve; If ALT or AST is greater than 5 times the upper limit of normal, therapy should be discontinued
- Co-administration with strong CYP3A inducers is not recommended as this may decrease the therapeutic efficacy of ivacaftor
Supplemental Patient Information
- Inform patient that liver function test should be conducted to assess the transaminase levels during treatment
- Advise patient to inform about any other medication including any herbal supplements or vitamins they are taking
- Advise patient to take the drug with fatty food for better absorption
Pregnancy Category:B
Breastfeeding: Ivacaftor is excreted into the milk of lactating female rats. According to the manufacturer, ivacaftor may be excreted in human milk; manufacturer advises caution while administering ivacaftor to a nursing woman.
