Difelikefalin comment watch save

  • FDA APPROVAL DATE: 08/23/2021
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    No clinical studies evaluating the drug interaction potential of difelikefalin were conducted.
  • PREGNANCY: Insufficient data in pregnant women to evaluate a drug-associated risk for major birth defects or miscarriage.

Dizziness, somnolence, and mental status changes have occurred in patients taking difelikefalin. Difelikefalin may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery until the effect of difelikefalin on a patient’s ability to drive or operate machinery is known.

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Page last updated 07/31/2023

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Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric