KYNAMRO Risk Evaluation and Mitigation Strategy (REMS)

The FDA has required a REMS Program for KYNAMRO® (mipomersen sodium) injection so that the benefits of the drug outweigh the risks to patients. The KYNAMRO REMS Program Coordinating Center is here to help health care providers and pharmacists complete the training, enroll, and be certified in the KYNAMRO REMS Program.

The goal of the KYNAMRO REMS Program is to mitigate the risk of hepatotoxicity associated with the use of KYNAMRO by ensuring that:

  • Health care providers are educated about the approved indication for KYNAMRO, the risk of hepatotoxicity associated with the use of KYNAMRO, and the need to monitor patients during treatment with KYNAMRO, as per product labeling
  • KYNAMRO is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH)
  • Patients are informed about the risk of hepatotoxicity associated with the use of KYNAMRO and the need for baseline and periodic monitoring

Both health care providers and pharmacies need to be trained, enrolled, and thereby certified in the KYNAMRO REMS Program before health care providers can prescribe KYNAMRO and pharmacies can dispense KYNAMRO.

For health care providers to become certified in the KYNAMRO REMS Program:
1

Train

Click to open and review all of the educational materials below, including the KYNAMRO REMS Certification Training Module and Knowledge Assessment.

The Training Module, PI, and Introduction are intended to be read in conjunction with your preparation for certification. The interactive Knowledge Assessment will follow the Training Module. You must correctly answer each of the 6 questions to become REMS certified to prescribe KYNAMRO. The estimated time to complete the Training Module and Knowledge Assessment is 30 minutes.

2

Enroll

Download and complete the Prescriber Enrollment Form below.
Fax completed form to 1-877-778-9008.

Prescriber Enrollment Form

For every new patient you wish to start on KYNAMRO:
Rx

Prescribe

  • Review the KYNAMRO REMS Program Patient Guide below with each patient to counsel the patient about the appropriate use and risks associated with KYNAMRO, and provide a copy to the patient
    Patient Guide
  • Complete the KYNAMRO REMS Program Patient-Prescriber Acknowledgment Form below for each patient, and fax the form to the KYNAMRO REMS Program Coordinating Center
    Patient-Prescriber Acknowledgment Form
  • Prescribe KYNAMRO for each patient by completing the KYNAMRO REMS Program Prescription Authorization Form below, and faxing the form to the KYNAMRO REMS Program Coordinating Center (1-877-778-9008)
    Prescription Authorization Form