Read the Medication Guide that comes with REVLIMID® before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare professional about your medical condition or your treatment. What is the most important information I should know about REVLIMID®?
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REVLIMID® is only for patients who understand and agree to all of the instructions in the REVASSIST® program.
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REVLIMID® may cause serious side effects including:
1.
birth defects
2.
low white blood cells and platelets
3.
blood clots in veins and in the lungs
1.
Possible 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®.
REVLIMID® is similar to the medicine thalidomide (THALOMID®). We know thalidomide causes life-threatening birth defects. REVLIMID® has not been tested in pregnant women. REVLIMID® has harmed unborn animals in animal testing.
Female patients must not get pregnant:
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for 4 weeks before starting REVLIMID®
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while taking REVLIMID®
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during dose interruptions of REVLIMID®
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for 4 weeks after stopping REVLIMID®
It is not known if REVLIMID® passes into semen, so:
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Male patients, including those who have had a vasectomy, must use a latex condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID® and for 4 weeks after stopping REVLIMID®.
If you get pregnant while taking REVLIMID®, stop taking it right away and call your healthcare professional. Female partners of males taking REVLIMID® should call their healthcare professional right away if they get pregnant. Healthcare professionals and patients should report all cases of pregnancy to:
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FDA MedWatch at 1-800-FDA-1088, and
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Celgene Corporation at 1-888-423-5436
2.
Low white blood cells (neutropenia) and low platelets (thrombocytopenia). 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. If you are being treated for del 5q myelodysplastic syndromes (MDS) your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID®, and at least monthly thereafter. If you are being treated for multiple myeloma, your blood counts should be checked every 2 weeks for the first 12 weeks and then at least monthly thereafter.
3.
An increased chance for blood clots in veins and in the lungs. Call your healthcare professional or get emergency medical care right away if you get the following signs or symptoms:
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shortness of breath
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chest pain
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arm or leg swelling
What is REVLIMID® and what is it used for?
REVLIMID® is a medicine taken by mouth to treat certain patients who have myelodysplastic syndromes (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 cell counts that require treatment with blood transfusions.
REVLIMID® is also used with dexamethasone to treat patients with multiple myeloma who have already had another treatment. Multiple myeloma is a cancer of plasma cells. Plasma cells are found in the bone marrow. Plasma cells produce a protein called antibodies. Some antibodies can attack and kill disease causing germs. Patients with this type of cancer may have low blood cell counts and immune problems giving them a higher chance for getting infections such as pneumonia. The bones can be affected leading to bone pain and breaks (fractures).
REVLIMID® can only be:
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prescribed by healthcare professionals who are registered in the RevAssist® program
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dispensed by a pharmacy that is registered in the RevAssist® program
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given to patients who are registered in the RevAssist® program and who agree to do everything required in the program
REVLIMID® has not been studied in children under 18 years of age. Who should not take REVLIMID®?
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Do not take REVLIMID® if you are pregnant, plan to become pregnant, or become pregnant during REVLIMID® treatment. REVLIMID® may cause birth defects. See "What is the most important information I should know about REVLIMID®?"
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Do not take REVLIMID® if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in REVLIMID®.
What should I tell my healthcare professional before taking REVLIMID®?
Tell your healthcare professional about all of your medical conditions, including if you:
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are pregnant or breastfeeding. REVLIMID® must not be used by women who are pregnant or breastfeeding.
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 to show your healthcare professional and pharmacist. How should I take REVLIMID®?
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Take REVLIMID® exactly as prescribed. You must also follow all the instructions of the RevAssist® program. Before prescribing REVLIMID®, your healthcare professional will:
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explain the RevAssist® program to you
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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.
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Swallow REVLIMID® capsules whole with water once a day. Do not break, chew, or open your capsules.
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If you miss a dose of REVLIMID®, take it as soon as you remember that day. If you miss taking your dose for the entire day, go back to taking your regular dose the next day. Do not take 2 doses at the same time.
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If you take too much REVLIMID® or overdose, call your healthcare professional or poison control center right away.
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You will have regular blood tests during your treatment with REVLIMID®. If you are being treated for del 5q myelodysplastic syndromes (MDS) you should have your blood tested every week during your first 8 weeks of treatment, and at least monthly after that. If you are being treated for multiple myeloma, your blood counts should be checked every two weeks for the first 12 weeks and then at least monthly after that. Your healthcare professional may adjust your dose of REVLIMID® or interrupt your treatment based on the results of your blood tests and on your general condition.
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Female patients who can get pregnant will get regular pregnancy testing.
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get a pregnancy test weekly for 4 weeks.
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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®.
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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.
What should I avoid while taking REVLIMID®?
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Do not get pregnant while taking REVLIMID® and for 4 weeks after stopping REVLIMID®. See "What is the most important information I should know about REVLIMID®?"
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Do not breastfeed while taking REVLIMID®. We do not know if REVLIMID® passes into your milk and harms your baby.
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Do not share REVLIMID® with other people. It may cause birth defects and other serious problems.
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Do not give blood while you take 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.
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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.
What are the possible side effects of REVLIMID®?
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REVLIMID® may cause serious side effects including:
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birth defects
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low white blood cells and platelets
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blood clots in veins and in the lungs
See "What is the most important information I should know about REVLIMID®?"
Other common side effects of REVLIMID® are:
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diarrhea
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itching
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rash
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tiredness
Tell your healthcare professional about any side effect that bothers you or that does not go away.
These are not all the side effects with REVLIMID®. Ask your healthcare professional or pharmacist for more information. How should I store REVLIMID®?
Store REVLIMID® at room temperature, 59° to 86°F (15° to 30° C). Keep REVLIMID® and all medicines out of the reach of children. General information about the safe and effective use of REVLIMID®
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not take REVLIMID® for conditions for which it was not prescribed. Do not give REVLIMID® to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide provides a summary of the most important information about REVLIMID®. If you would like more information, talk with your healthcare professional. You can ask your healthcare professional or pharmacist for information about REVLIMID® that is written for health professionals. You can also call 1-888-423-5436 or visit www.REVLIMID.com. What are the ingredients in REVLIMID®?
REVLIMID® (lenalidomide) capsules contain 5 mg, 10 mg, 15 mg or 25 mg of lenalidomide and are available as gelatin capsules for oral administration.
The inactive ingredients of REVLIMID® capsules are: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
The 5 mg and 25 mg capsule shells contain gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink.
Manufactured for Celgene Corporation
Summit, NJ 07901
This Medication Guide has been approved by the US Food and Drug Administration.
REVLIMID®
(lenalidomide) in combination with dexamethasone is indicated for the treatment
of multiple myeloma patients who have received at least one prior therapy.
REVLIMID®
(lenalidomide) is indicated for patients with transfusion-dependent anemia due to
Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion
5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Important Safety Information
REVLIMID®
(lenalidomide) in combination with dexamethasone is indicated for the treatment
of multiple myeloma patients who have received at least one prior therapy.
REVLIMID®
(lenalidomide) is indicated for patients with transfusion-dependent anemia due to
Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion
5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Important Safety Information
ADDITIONAL WARNINGS: HEMATOLOGIC
TOXICITY
Multiple Myeloma
In the pooled multiple myeloma studies, Grade 3 and 4 hematologic
toxicities were more frequent in patients treated with the combination of REVLIMID® (lenalidomide) and dexamethasone
than in patients treated with dexamethasone alone
Patients on therapy should have their complete blood counts monitored
every 2 weeks for the first 12 weeks and then monthly thereafter
Patients may require dose interruption and/or dose reduction
CONTRAINDICATIONS:
Pregnancy Category X:
Lenalidomide is contraindicated in pregnant women and women capable
of becoming pregnant. When there is no alternative, females of childbearing potential
may be treated with lenalidomide provided adequate precautions are taken to avoid
pregnancy
Hypersensitivity:
REVLIMID® (lenalidomide)
is contraindicated in any patients who have demonstrated hypersensitivity to the
drug or its components
PRECAUTIONS:
Angioedema, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis:
Angioedema and serious dermatologic reactions including Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events
can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide
treatment should not receive REVLIMID®
(lenalidomide). REVLIMID® (lenalidomide)
interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID® (lenalidomide) must be discontinued
for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected,
and should not be resumed following discontinuation for these reactions
Tumor Lysis Syndrome:
Lenalidomide has antineoplastic activity and therefore the complications
of tumor lysis syndrome may occur. The patients at risk of tumor lysis syndrome
are those with high tumor burden prior to treatment. These patients should be monitored
closely and appropriate precautions taken
Renal impairment:
Since lenalidomide is primarily excreted unchanged by the kidney,
adjustments to the starting dose of REVLIMID®
(lenalidomide) are recommended to provide appropriate drug exposure in patients
with moderate or severe (CLcr < 60 mL/min) renal impairment and in patients
on dialysis
Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it would be prudent to monitor
renal function
Nursing mothers: It is not known
whether REVLIMID® (lenalidomide)
is excreted in human milk.
Because of the potential for adverse reactions in nursing infants,
a decision should be made whether to discontinue nursing or the drug, taking into
account the importance of the drug to the mother
ADVERSE REACTIONS:
Multiple Myeloma
In the REVLIMID®
(lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least
one dose interruption with or without a dose reduction of REVLIMID® (lenalidomide) compared to 21% in the placebo/dexamethasone
treatment group
Of these patients who had one dose interruption with or without
a dose reduction, 50% in the REVLIMID®
(lenalidomide)/dexamethasone treatment group underwent at least one additional dose
interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone
treatment group
Most adverse events and Grade 3/4 adverse events were more frequent
in MM patients who received the combination of REVLIMID®
(lenalidomide)/dexamethasone compared to placebo/dexamethasone
Other adverse events reported in multiple myeloma
patients (REVLIMID® (lenalidomide)/dexamethasone
vs dexamethasone/placebo): constipation (39% vs 19%), fatigue (38% vs 37%),
insomnia (32% vs 37%), muscle cramp (30% vs 21%), diarrhea (29% vs 25%), neutropenia
(28% vs 5%), anemia (24% vs 17%), asthenia (23% vs 25%), pyrexia (23% vs 19%), nausea
(22% vs 19%), headache (21% vs 21%), peripheral edema (21% vs 19%), dizziness (21%
vs 15%), dyspnea (20% vs 15%), tremor (20% vs 7%), decreased weight (18% vs 14%),
thrombocytopenia (17% vs 10%), rash (16% vs 8%), back pain (15% vs 14%), hyperglycemia
(15% vs 14%), and muscle weakness (15% vs 15%).
Myelodysplastic Syndromes
Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148)
were the most frequently reported adverse events observed in the del 5q MDS population
Other adverse reactions reported in del 5q MDS patients
(REVLIMID® (lenalidomide)):
diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea
(24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%),
peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp
(18%), dyspnea (17%), and pharyngitis (16%).
DOSAGE AND ADMINISTRATION:
Dosing is continued or modified based upon clinical and laboratory
findings. Dosing modifications are recommended to manage Grade 3 or 4 neutropenia
or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID® (lenalidomide)
For other Grade 3 or 4 toxicities judged to be related to REVLIMID® (lenalidomide), hold treatment and
restart at next lower dose level when toxicity has resolved to less than or equal
to Grade 2
Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS,
and ADVERSE REACTIONS.
