Approved Risk Evaluation and Mitigation Strategies (REMS)

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Pomalyst (pomalidomide)
NDA #204026
REMS last update: 04/22/2016

View the Pomalyst Prescribing Information and Medication Guide at DailyMed.
View Pomalyst's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the product-specific REMS website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Pomalyst

To be able to prescribe Pomalyst
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before writing the first prescription for a patient
  • Counsel the patient on the benefits and risks of Pomalyst therapy, including risks described in the boxed warning, and to complete mandatory surveys (phone or online) at program specified frequencies
  • For an Adult Female of Reproductive Potential: counsel the patient on contraception and emergency contraception.
  • For an Adult Female of Reproductive Potential: assess the patient’s pregnancy status by ordering a pregnancy test and verifying a negative pregnancy result.
  • Enroll the patient by completing and submitting the Patient –Physician Agreement Form.
  • Obtain a unique prescription authorization number by contacting the Celgene Customer Care Center and completing the Prescriber Survey. Document the unique prescription authorization number on the prescription.
  • Prescribe no more than a 4-week (28-day) supply of Pomalyst.
  • Do not prescribe refills.
Before writing each prescription after the first prescription
  • For an Adult Female of Reproductive Potential: counsel the patient on contraception and emergency contraception.
  • For an Adult Female of Reproductive Potential: assess patient’s pregnancy status by ordering a pregnancy test and verifying a negative pregnancy result.
  • Obtain a unique prescription authorization number by contacting Celgene Customer Care Center and completing the Prescriber Survey. Document the unique prescription authorization number on the prescription.
  • Prescribe no more than a 4-week (28-day) supply of Pomalyst.
  • Do not prescribe refills.
Ongoing
  • Re-enroll patients in the Pomalyst REMS program every time treatment has been discontinued for 12 consecutive months.
  • Report any pregnancies in a female patient or female partners of male patients to the sponsor.
  • Return unused product brought in by patients to the manufacturer.

Patients who receive Pomalyst

To be able to receive Pomalyst
  • Enroll in the REMS by completing the Patient-Physician Agreement Form with the prescriber.
Before receiving the initial Pomalyst prescription
  • For a Female of Reproductive Potential: undergo a pregnancy test.
  • For a Female of Reproductive Potential: receive counseling he prescriber on contraception and emergency contraception.
  • Complete the Patient Survey at program specified frequencies.
Before receiving each subsequent prescription
  • For a Female of Reproductive Potential: undergo a pregnancy test.
While taking Pomalyst
  • Complete the Patient Survey at program specified frequencies.
Ongoing
  • Inform the prescriber if you become pregnant or suspect that you may be pregnant.

Pharmacies that dispense Pomalyst

Before dispensing Pomalyst
  • Counsel the patient (parent and/or guardian of patient) according to the appropriate patient risk category using the Education and Counseling Checklist for Pharmacies.
  • Obtain authorization to dispense by contacting the Celgene Customer Care Center to obtain a confirmation number. Document the confirmation number on the prescription.
  • Dispense no more than a 4-week (28-day) supply.
  • Do not dispense refills.
  • Dispense subsequent prescriptions only if there are 7 days or less remaining on the existing prescription.
Ongoing
  • Return unused product to the manufacturer.
  • Maintain records of each Pomalyst prescription dispensed and the corresponding completed Education and Counseling Checklist for Pharmacies.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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