FDA Approves New Treatment for Myelodysplastic Syndrome (MDS)
The Food and Drug Administration (FDA) has approved the drug Revlimid
(lenalidomide) for the treatment of patients with a subtype of Myelodysplastic
Syndrome (MDS). The subtype is MDS patients with deletion 5q cytogenetic
"This new product will offer a much needed treatment option for patients
suffering from this rare illness that, in some cases, has been found to
progress to fatal forms of leukemia," said Dr. Steven Galson, M.D., Director of
FDA's Center for Drug Evaluation and Research (CDER).
Revlimid is structurally similarto thalidomide, a drug known to cause severe
birth defects. Additional studies are ongoing in animals to address whether
there is a risk that Revlimid will also cause birth defects when taken during
pregnancy. While these studies are under way, the company is marketing
Revlimid under a risk management plan called RevAssist, designed to prevent
Under RevAssist, only pharmacists and prescribers registered with the
program will prescribe and dispense Revlimid. The program requires patients,
including female patients undergoing mandatory pregnancy testing, to give
informed consent before starting Revlimid. Physicians are to check pregnancy
tests, limit prescriptions to a one-month mail supply, and report any
pregnancies to FDA. FDA and the manufacturer will re-evaluate the risk
management plan when results of further animal testing for birth defects are
The labeling for Revlimid will include a Black Box Warning and a Medication
Guide regarding the prevention of fetal exposure. Additional Black Box
Warnings include the potential need to lower the dose due to suppressed
blood counts and increased risk of blood clots. Common side effects reported
with Revlimid include thrombocytopenia (low platelet count), neutropenia (low
white blood cell count), diarrhea, pruritis (itch), rash, and fatigue.
Revlimid is distributed by Celgene Corporation of Summit, N.J.
FDA News FDA Approves New Treatment for Myelodysplastic Syndrome
(MDS) December 28, 2005
Questions and Answers on Revlimid (lenalidomide)
What is Revlimid used for?FDA Approves New Treatment for Myelodysplastic
Revlimid (lenalidomide) is approved to treat a subgroup of patients with
Myelodysplastic Syndrome (MDS).
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
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.
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.
Will the labeling for Revlimid have a Black Box Warning or Medication
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.
Is this product the same as thalidomide?
This product is chemically similar to thalidomide, but is not the same as
Is this Risk Management Program the same as the program in place for
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.
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
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 Â– 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 Â– Revlimid educational materials include a medication
guide and other patient brochures. Materials for thalidomide include an
educational video in addition to a brochure.
Packaging Â–Thalidomide comes in blister packs with additional safety
information. Revlimid does not have blister packaging.
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
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.
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.
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 Â– 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.
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.
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.
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