 |
Questions and Answers on
Revlimid (lenalidomide)
-
What is Revlimid used for?
Revlimid (lenalidomide) is approved to treat a
subgroup of patients with Myelodysplastic Syndrome (MDS).
-
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.
-
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.
-
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 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.
-
Is this product the same as thalidomide?
This product is chemically similar to thalidomide,
but is not the same as thalidomide.
-
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.
-
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 – 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.
-
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.
-
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 – 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.
 Back
to Top 
Back to Revlimid
 PDF requires the free Adobe
Acrobat Reader
Date created: December 28, 2005 |
|
