This is a summary of the most
important information about Revlimid. For details, talk to your
healthcare professional.
What Is Revlimid?
Revlimid is a
medicine taken by mouth to treat certain patients who have
myelodysplastic syndrome (MDS). Patients with MDS have bone
marrow that does not produce enough mature blood cells. This
causes a lack of healthy blood cells that can function properly
in the body. There are different types of MDS. Revlimid is for
the type of MDS with a chromosome problem where part of
chromosome 5 is missing. This type of MDS is known as deletion
5q MDS. Patients with this type of MDS may have low red blood
counts that require treatment with blood transfusions.
Revlimid can
only be:
-
prescribed
by healthcare professionals who are registered in the
RevAssist program
-
dispensed by
a pharmacy that is registered in the RevAssist program
-
given to
patients who are registered in the
RevAssist program and who agree to adhere
to the program
Revlimid has
not been studied in children under 18 years of age.
Who Should Not
Use Revlimid?
Do not take Revlimid if you
are:
-
pregnant,
plan to become pregnant or become pregnant during treatment
-
allergic to
Revlimid or any of the ingredients in Revlimid
What Are The Risks?
The
following are the major potential risks and side
effects of Revlimid therapy. However, this list is not
complete.
The following are the major
possible risks and side effects of
Revlimid therapy:
- Birth defects
(deformed babies) or death of an unborn baby. Female
patients who are pregnant or who plan to become pregnant must
not take Revlimid. Female patients must not get pregnant:
-
for 4 weeks before starting
Revlimid
-
while taking Revlimid
-
during dose interruptions of
Revlimid
-
for 4 weeks after stopping
Revlimid
Female partners of males taking
Revlimid should call their healthcare professional right away if
they get pregnant.
- Low white blood cells
and platelets. Revlimid causes low
white blood cells and low platelets in most patients. You may
need a blood transfusion or certain medicines if your blood
counts drop too low.
- Blood clots in the
veins and in the lungs. Call your
healthcare professional or get emergency medical care right
away if you get the following signs or symptoms:
-
shortness of breath
-
chest pain
-
arm or leg swelling
- Some common side
effects that may occur with Revlimid
include:
-
diarrhea
-
itching
-
rash
-
tiredness
What Should I Tell My
Healthcare Professional?
Before
you start taking Revlimid, tell your healthcare professional
if you:
- are trying to become pregnant, are already
pregnant, or are breast-feeding. Revlimid must not be used by
women who are pregnant or breastfeeding.
- give blood. Do not give blood while
taking Revlimid and
for 4 weeks after stopping Revlimid. If someone who is pregnant gets your donated blood, her baby
may be exposed to Revlimid and may be
born with birth defects.
- donate sperm. Male patients should not
donate sperm while taking Revlimid and for 4 weeks after
stopping Revlimid. If a female who is trying to become
pregnant gets your sperm, her baby may be exposed to Revlimid
and may be born with birth defects.
- have or had kidney problems
Can
Other Medicines Or Food Affect Revlimid?
Tell
your healthcare professional about all the medicines you take
including prescription and non-prescription medicines, vitamins,
and herbal supplements. It is possible that Revlimid and other
medicines may affect each other causing serious side effects.
Know the medicines you take.
Keep a list of them with you to show your healthcare
professional.
How
Should I Take Revlimid?
-
Take
Revlimid exactly as prescribed. You must also follow all the
instructions of the RevAssist program. Before prescribing
Revlimid, your healthcare professional will:
-
explain the RevAssist program to
you
-
have you sign the
Patient-Physician Agreement Form
You will
not be prescribed Revlimid if you cannot agree to or follow all
of the instructions of the RevAssist program.
-
You will get
no more than a 28-day supply of
Revlimid at one time. This is to make sure you follow the
RevAssist program.
-
Swallow Revlimid capsules whole with water once a day. Do not
break, chew, or open your capsules.
-
You will
have regular blood tests during treatment with Revlimid.
-
If you take
too much Revlimid or overdose, call your healthcare
professional or poison control center right
away.
-
Female
patients who can get pregnant will get regular pregnancy
testing.
-
Female
patients who can become pregnant must agree to use 2 separate
forms of effective birth control at the same time, 4
weeks before, while taking, and for 4 weeks after
stopping Revlimid.
-
Male
patients, even those who have had a
vasectomy, must agree to use a latex condom during sexual
contact with a pregnant female or a
female who can become pregnant.
-
Do not share
Revlimid with other people. It may cause birth defects
and other serious problems.
Date Approved:
12/27/2005