Taking REVLIMID® in Combination
with Dexamethasone
Take REVLIMID® (lenalidomide) exactly as prescribed by your healthcare provider.
REVLIMID® is only available through the RevAssist® program, and you must agree to comply with the requirements of the RevAssist® program.
REVLIMID® may cause birth defects or death to an unborn baby if taken during pregnancy. Do not take REVLIMID® if you are pregnant or plan on becoming pregnant.
If you get pregnant while taking REVLIMID®, stop taking it right away and call your healthcare provider. Female partners of males taking REVLIMID® should call their healthcare provider right away if they get pregnant. Healthcare providers and patients should report all cases of pregnancy to:
- FDA MedWatch at 1-800-FDA-1088, and
- Celgene Corporation at 1-888-423-5436
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You will get no more than a 28-day supply of REVLIMID® at one time. This is to make sure that you follow the RevAssist® program.
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REVLIMID® comes in 4 capsule strengths: 5 mg, 10 mg, 15 mg, and 25 mg. Swallow REVLIMID® capsules whole with water once a day. Do not break, chew, or open your capsules.
Always take your medicine exactly as directed by your healthcare provider.
- The most common starting dose of REVLIMID® for patients with multiple myeloma is 25 mg.
- REVLIMID® is taken once a day, every day, for 21 days.
- After a 7-day break, resume taking REVLIMID®.
- REVLIMID® may be taken with or without food.
- If you miss a dose of REVLIMID®, take it as soon as you remember, if you remember on the day you missed the dose.
- 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.
- If you take too much REVLIMID®, or overdose, call your healthcare provider or poison control center right away.
- Talk to your healthcare provider if you have questions about taking REVLIMID®.
Your blood counts should be checked regularly (every 2 weeks for the first 12 weeks of therapy and at least monthly thereafter). Work with your healthcare provider to schedule these blood tests. Your healthcare provider may adjust your dose of REVLIMID® or interrupt your treatment based on the results of your blood tests and on your general condition.
In clinical studies, the dose of dexamethasone studied in combination with REVLIMID® was 40 mg once a day given in a "pulsed" regimen, as follows:
- 40 mg once a day for the first 4 cycles, on days 1-4, 9-12, and 17-20
- After the first 4 cycles of treatment, on days 1-4 only
- Given in 28-day cycles
Your healthcare provider will tell you which dose of dexamethasone is right for you.
- DO NOT get pregnant while taking REVLIMID® and for 4 weeks after stopping REVLIMID®.
- Female patients who can get pregnant will get regular pregnancy testing.
- Get a pregnancy test weekly for 4 weeks.
- Thereafter, the patient must have a pregnancy test every 4 weeks if she has a regular menstrual cycle or every 2 weeks if her cycles are irregular.
- 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. This is required during REVLIMID® treatment and for 4 weeks after stopping therapy.
- DO NOT share REVLIMID® with other people. It may cause birth defects and other serious problems.
- 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.
- 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.
Important Safety Information
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REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
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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.
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WARNINGS:
1. POTENTIAL FOR HUMAN BIRTH DEFECTS.
LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN
THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. FEMALES
SHOULD BE ADVISED TO AVOID PREGNANCY WHILE TAKING REVLIMID®
(lenalidomide).
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Special Prescribing Requirements
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BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL
EXPOSURE TO REVLIMID® (lenalidomide),
REVLIMID® (lenalidomide) IS ONLY
AVAILABLE UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM. THIS PROGRAM IS CALLED
"RevAssist®". UNDER THIS PROGRAM,
ONLY PRESCRIBERS AND PHARMACISTS REGISTERED WITH THE PROGRAM CAN PRESCRIBE AND DISPENSE
THE PRODUCT. IN ADDITION, REVLIMID®
(lenalidomide) MUST ONLY BE DISPENSED TO PATIENTS WHO ARE REGISTERED AND MEET ALL
THE CONDITIONS OF THE RevAssist®
PROGRAM.
2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
THIS DRUG IS ASSOCIATED WITH SIGNIFICANT NEUTROPENIA AND THROMBOCYTOPENIA. EIGHTY
PERCENT OF PATIENTS WITH DEL 5q MYELODYSPLASTIC SYNDROMES HAD TO HAVE A DOSE DELAY/REDUCTION
DURING THE MAJOR STUDY. THIRTY-FOUR PERCENT OF PATIENTS HAD TO HAVE A SECOND DOSE
DELAY/REDUCTION. GRADE 3 OR 4 HEMATOLOGIC TOXICITY WAS SEEN IN 80% OF PATIENTS ENROLLED
IN THE STUDY. PATIENTS ON THERAPY FOR DEL 5q MYELODYSPLASTIC SYNDROMES SHOULD HAVE
THEIR COMPLETE BLOOD COUNTS MONITORED WEEKLY FOR THE FIRST 8 WEEKS OF THERAPY AND
AT LEAST MONTHLY THEREAFTER. PATIENTS MAY REQUIRE DOSE INTERRUPTION AND/OR REDUCTION.
PATIENTS MAY REQUIRE USE OF BLOOD PRODUCT SUPPORT AND/OR GROWTH FACTORS. (SEE DOSAGE
AND ADMINISTRATION)
3. DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM.
THIS DRUG HAS DEMONSTRATED A SIGNIFICANTLY INCREASED RISK OF DEEP VENOUS THROMBOSIS
(DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS WITH MULTIPLE MYELOMA WHO WERE TREATED
WITH REVLIMID® (lenalidomide)
COMBINATION THERAPY. PATIENTS AND PHYSICIANS ARE ADVISED TO BE OBSERVANT FOR THE
SIGNS AND SYMPTOMS OF THROMBOEMBOLISM. PATIENTS SHOULD BE INSTRUCTED TO SEEK MEDICAL
CARE IF THEY DEVELOP SYMPTOMS SUCH AS SHORTNESS OF BREATH, CHEST PAIN, OR ARM OR
LEG SWELLING. IT IS NOT KNOWN WHETHER PROPHYLACTIC ANTICOAGULATION OR ANTIPLATELET
THERAPY PRESCRIBED IN CONJUNCTION WITH REVLIMID®
(lenalidomide) MAY LESSEN THE POTENTIAL FOR VENOUS THROMBOEMBOLIC EVENTS. THE DECISION
TO TAKE PROPHYLACTIC MEASURES SHOULD BE DONE CAREFULLY AFTER AN ASSESSMENT OF AN
INDIVIDUAL PATIENT'S UNDERLYING RISK FACTORS.
You can get the information about REVLIMID®
(lenalidomide) and the RevAssist®
program on the Internet at www.REVLIMID.com or by calling the manufacturer's
toll-free number at
1-888-423-5436.
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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:
Hypersensitivity: REVLIMID® (lenalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.
PRECAUTIONS:
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.
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