Overview of the Letairis REMS Program

You can now enroll a female patient in the Letairis REMS Program online by clicking here. Or, you can download the forms below and FAX, as directed.

Download Letairis REMS Materials

In order to ensure that Letairis is prescribed and taken safely, Gilead has worked with the FDA to develop materials for the Letairis REMS Program to inform prescribers and patients about the risk of serious birth defects.

Letairis REMS Program
Prescriber Materials

Letairis REMS Program
Patient Education Materials

Letairis REMS Program Guide for
Female Patients
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  • Prescribers must enroll in the Letairis REMS Program and comply with the Letairis REMS Program requirements to prescribe Letairis
  • All female patients must enroll in the Letairis REMS Program to receive Letairis
  • Prescribers must educate and counsel Females of Reproductive Potential and Pre-Pubertal Females as described in the Prescriber Guide for the Letairis REMS Program. The parent/guardian of the Pre-Pubertal Female must also be educated and counseled on the risks of Letairis
  • Required pregnancy testing for Females of Reproductive Potential prior to writing a prescription for Letairis and monthly thereafter, including 1 month after stopping treatment with Letairis
  • Letairis is only available through a restricted distribution program

Changes to the Letairis REMS Program (November 2018)

  • Revised: Prescriber Guide for the Letairis REMS Program: Risk of teratogenicity and removal of Medication Guide
  • Revised title and content: Letairis REMS Program Guide for Females Who Can Get Pregnant to Letairis REMS Program Guide for Female Patients
  • Removal of the Medication Guide from REMS materials
    • Revised form: Letairis REMS Patient Enrollment and Consent Form
    • Revised form: Prescriber Enrollment and Agreement Form
  • Updated: REMS Website (www.letairisrems.com)
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