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U.S. Department of Health and Human Services


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Questions and Answers on Revlimid (lenalidomide)


1. What is Revlimid used for?

Revlimid (lenalidomide) is approved to treat a subgroup of patients with Myelodysplastic Syndrome (MDS).

2. What is MDS?

MDS is a collection of disorders in which the bone marrow does not function normally and not enough normal blood cells are made. MDS may develop following treatment with drugs or radiation therapy for other diseases or it may develop without any known cause. Some forms of MDS can progress to acute myeloid leukemia (AML), a type of cancer in which too many white blood cells are made.

3. Is there a Risk Management Plan in place for Revlimid?

Yes. The sponsor, Celgene Corporation, submitted a Risk Management Program to prevent pregnancy exposures to this drug. This program is called RevAssist.

4. Why is there a Risk Management Plan for Revlimid?

Because of the potential for birth defects, exposure of a developing fetus to this product must be avoided. Revlimid will only be available under a special restricted distribution program approved by FDA.

5. What are the goals for RevAssist?

The goals of the RevAssist plan are to:

  • Prevent fetal exposure to Revlimid by registering and educating all physicians, pharmacists and patients and monitoring pregnancy prevention activities.

  • Reduce the risk of fetal exposure from males taking Revlimid who engage in sexual contact with a female partner of child bearing potential.

  • Educate physicians, other healthcare providers, and patients about potential lowering in blood cell counts (cytopenias) associated with Revlimid therapy.

6. Will the labeling for Revlimid have a Black Box Warning or Medication Guide?

In addition to the RevAssist program, the labeling for Revlimid will include a Black Box Warning discussing the possibility of birth defects, increased risk of lowering of blood cells or platelets, and increased risk of blood clots. A medication guide is also part of the approved labeling, and must be given to patients with each prescription.

7. Is this product the same as thalidomide?

This product is chemically similar to thalidomide, but is not the same as thalidomide.

8. Is this Risk Management Program the same as the program in place for thalidomide?

The RevAssist program has very similar components to the program for thalidomide (System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) but does differ in some areas.

9. What are the key similarities to the thalidomide S.T.E.P.S. program?

Both programs include the following safety measures:

  • Mandatory registration of all patients, prescribers, and pharmacies

  • Pregnancy testing in all females of childbearing potential

  • Education for prescribers, pharmacists, and patients

  • No refills and a 28-day limit to prescriptions

10. What are the key differences to the thalidomide S.T.E.P.S. program?

The main differences between the two programs are in the following areas:

  • Distribution -- Revlimid will be distributed to specialty pharmacies; while thalidomide is distributed to both retail and specialty pharmacies registered in the S.T.E.P.S. program.

  • Pharmacist interaction – Pharmacists will call patients on the telephone to educate them about the potential for birth defects before dispensing Revlimid. With thalidomide, patients get face to face counseling from their pharmacists.

  • Education materials – Revlimid educational materials include a medication guide and other patient brochures. Materials for thalidomide include an educational video in addition to a brochure.

  • Packaging –Thalidomide comes in blister packs with additional safety information. Revlimid does not have blister packaging.

11. Does this product cause the same type of birth defects as thalidomide?

The company performed two studies in animals to look for evidence of birth defects. After review of these studies, FDA believed they were inadequate to accurately characterize the risk of birth defects with fetal exposure to the active ingredient in Revlimid, lenalidomide, and has recommended additional studies in order to more fully assess whether or not this product may cause birth defects in pregnant females that are similar to those caused by thalidomide.

12. What must a female patient of child bearing potential do to obtain a prescription for Revlimid under the RevAssist program?

Before obtaining a prescription for Revlimid, females of child bearing potential must be counseled by a physician or an expert in contraception not to get pregnant while taking Revlimid. If necessary, females of child bearing potential will be taught why and how to use 2 effective methods of contraception at the same time in order to avoid pregnancy. All females of child bearing potential must pass a test at the start of treatment and each subsequent month of treatment to make sure they understand pregnancy prevention and that their risk of fetal exposure is low. The test is done by using push buttons to answer questions asked over the telephone.

Also before starting Revlimid, females of child bearing potential must sign (along with the physician) an agreement to show they understand the need not to get pregnant while taking Revlimid. females of child bearing potential must have 2 negative pregnancy tests documented by their doctor to start Revlimid. The first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing Revlimid. A negative pregnancy test, along with a satisfactory the phone test, is needed from female of child bearing potential every month before a new Revlimid prescription can be dispensed.

13. What will FDA do if exposure to this product results in birth defects?

Any suspected fetal exposure to Revlimid should be reported to the manufacturer or to FDA via the MedWatch system. Celgene will follow all exposed pregnancies to see if any birth defects occur. If birth defects are seen or if fetal exposures to Revlimid are reported, FDA will re-evaluate the program to see if it should be modified since these should not occur if the RevAssist program is working like it is supposed to.

14. How will the use of Revlimid be monitored?

As with all drugs, FDA will carefully monitor the use of this product once it is on the market. In addition, Celgene plans to evaluate pregnancy and other adverse events through the following measures:

  • Reports on pregnancy – The company plans to measure the number of exposed pregnancies and outcomes via spontaneous adverse event reports. They will rapidly notify FDA about all exposed pregnancies and outcomes under expedited reporting mechanisms.

  • Audits of the specialty pharmacies to determine whether there is consistency and adherence to the RevAssist program.

15. How will Revlimid be supplied?

Revlimid will be available as 5 mg or 10 mg oral capsules. Revlimid will be limited to a maximum of a 28 day supply.

16. Will Revlimid be prescription only or available over-the-counter?

Revlimid will be available by prescription only from physicians and can be filled only by a limited number of specialty pharmacies. Most of these pharmacies will operate by fax, phone calls, and express shipments to patients.