What is lenalidomide?
Lenalidomide affects the immune system. It helps promote immune responses to prevent
inflammation in the body.
Lenalidomide treats anemia (a lack of red blood cells in the body) and multiple myeloma
(cancer resulting from a progressive blood disease). It is used in patients with myelodysplastic
syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS,
because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not
produce enough healthy blood cells.
Lenalidomide may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking lenalidomide?
If you have certain conditions, you may need a dose adjustment or special tests to safely take
this medication. Before taking lenalidomide, tell your doctor if you have:
Lenalidomide can cause severe, life-threatening birth
defects or death of a baby if the mother or the father is taking this medication at the time of
conception or during pregnancy.
Even one dose of lenalidomide can cause major birth
defects of the baby's arms and legs, bones, ears, eyes, face, and heart.
Never use
lenalidomide if you are pregnant.
Tell your doctor right away if your period is late while
using the medication.
It is not known if lenalidomide passes into breast milk or if it could harm a nursing baby.
Do not use this medication without telling your doctor if you are breast-feeding a baby.
For Women:
If you have not had a hysterectomy or have not been in
menopause for at least 24 months in a row, you will be required to use two forms of birth control
beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it.
Even women with fertility problems are required to use birth control while taking this medication. You
must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours
before. While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.
The birth control method you use must be proven highly effective, such as birth control pills, an
intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth
control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.
Stop using lenalidomide and call your doctor at once if you quit using birth control, if your
period is late, or if you think you might be pregnant.
For Men:
You must not cause a woman to become pregnant while you are
taking lenalidomide because the medicine may affect your sperm and cause birth defects in the baby.
You must agree in writing to always use latex condoms when having sex with a woman who is able to
get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex,
even once, or if you think your female sexual partner may be pregnant.
Lenalidomide is available only under a special program called RevAssist. Under this program,
only registered doctors and pharmacists can prescribe and dispense lenalidomide. You must be
registered in the program and sign documents stating that you understand the dangers of this medication
and that you agree to use birth control measures as required by the program.
For patients between 12 and 18 years, a parent or legal guardian must read all written
requirements for the RevAssist program and sign the agreements on behalf of the patient.
How should I take lenalidomide?
While you are using lenalidomide, you will be required to be listed on a patient registry and
participate in occasional telephone surveys. You will be limited to a 28-day supply of lenalidomide
each time your prescription is refilled. You may continue getting refills only if you participate fully in the
RevAssist program and commit to all agreements.
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or
for longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these
directions carefully.
Never
give lenalidomide to another person, even if he or she has
the same disorder for which you are being treated.
Your doctor may occasionally change your dose to make sure you get the best results from this
medication.
Take each dose with a full glass of water.
Swallow the capsule whole, without breaking it open.
To be sure lenalidomide is helping your condition and not causing harmful effects, your blood
will need to be tested every week for the first two months of treatment, and then every month after that.
Do not miss any visits to your doctor.
Store lenalidomide at room temperature away from moisture and heat.
What happens if I miss a dose of lenalidomide?
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the
missed dose and take only the next regularly scheduled dose.
Do not
take extra
medicine to make up the missed dose.
Where can I get more information about lenalidomide?
Your pharmacist has information about lenalidomide written for health professionals that you may read.
What are the possible side effects of lenalidomide?
Stop using lenalidomide and get emergency medical help if you have any of these
signs of an allergic reaction:
hives; difficulty breathing; swelling of your face, lips, tongue,
or throat.
Call your doctor at once if you have any of these serious side effects:
-
chest pain, sudden shortness of breath, coughing up blood;
-
pain or swelling in your arm, thigh, or calf;
-
easy bruising, unusual bleeding or weakness;
-
fever, chills, body aches, flu symptoms;
-
lower back pain, blood in your urine;
-
urinating less than usual or not at all;
-
numbness or tingly feeling around your mouth;
-
muscle weakness, tightness, or contraction, overactive
reflexes;
-
fast or slow heart rate, weak pulse, feeling short of breath,
confusion, fainting;
-
severe blistering, peeling, and red skin rash; or
-
the first sign of any skin rash, no matter how mild.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about lenalidomide?
Lenalidomide can cause severe, life-threatening birth defects or death of a
baby if the mother or the father is taking this medication at the time of conception or during
pregnancy.
Even one dose of lenalidomide can cause major birth defects of the baby's arms
and legs, bones, ears, eyes, face, and heart.
Never use lenalidomide if you are pregnant.
For Women:
You will be required to use two reliable forms of birth control
beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it.
Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a
row must agree in writing to use birth control before, during, and after taking lenalidomide. Even
women with fertility problems are required to use birth control while taking this medication. You must
also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before.
While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.
Stop using lenalidomide and call your doctor at once if you quit using birth control, if your
period is late, or if you think you might be pregnant.
For Men:
You must not cause a woman to become pregnant while you are
taking lenalidomide because the medicine may affect your sperm and cause birth defects in the baby.
You must agree in writing to always use latex condoms when having sex with a woman who is able to
get pregnant, even if you have had a vasectomy.
Lenalidomide is available only under a special program called RevAssist. You must be
registered in the program and sign documents stating that you understand the dangers of this medication
and that you agree to use birth control measures as required by the program.
This medication comes with patient instructions for safe and effective use. Follow these
directions carefully.
Never
give lenalidomide to another person, even if he or she has
the same disorder for which you are being treated.
Do not donate blood or sperm while you are using lenalidomide.
What should I avoid while taking lenalidomide?
Do not donate blood or sperm while you are using lenalidomide.
What other drugs will affect lenalidomide?
There may be other drugs that can affect lenalidomide. Tell your doctor about all the
prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start using a new medication without telling
your doctor.
What happens if I have an overdose of lenalidomide?
