Revlimid (generic: lenalidomide) is a prescription medication used to treat certain patients who have myelodysplastic syndrome (MDS, bone marrow that does not produce enough mature blood cells). Revlimid is also used with dexamethasone to treat people with multiple myeloma who have already had another treatment. Multiple myeloma is a cancer of plasma cells.
Revlimid belongs to a group of drugs called immunomodulary agents. It works by helping the bone marrow produce normal blood cells and killing abnormal cells in the bone marrow.
This medication comes in capsule form. It is usually taken once daily, with water. Swallow Revlimid capsules whole.
Common side effects of Revlimid are diarrhea, itching, and rash.
Revlimid is a prescription medicine used to treat certain patients who have myelodysplastic syndromes (MDS), specifically 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 and requires blood transfusions.
Revlimid is also used with dexamethasone to treat people with multiple myeloma who have already had another treatment.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Important warning: See Black Box Warning
Revlimid may cause serious side effects.
- Serious skin reactions. Serious skin reactions can happen with Revlimid and may cause death. Call your healthcare provider right away if you have any skin reaction while taking Revlimid.
- Tumor lysis syndrome. Metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and may include the following: changes to blood chemistry, high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.
Common side effects of Revlimid are:
These are not all the possible side effects of Revlimid. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take digoxin (Lanoxin).
- Do not take Revlimid if you are pregnant, plan to become pregnant, or become pregnant during Revlimid treatment and for 4 weeks after stopping Revlimid treatment.
- For male patients: including those who have had a vasectomy, must use a latex condom during any sexual contact with a pregnantfemale or a female that can become pregnant while taking Revlimid, during any breaks (interruptions) in your treatment with Revlimid, and for 4 weeks after stopping Revlimid. (If you or your partner are allergic to latex, please consult with your healthcare provider) Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant. Do not donate sperm while taking Revlimid, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping Revlimid. If a female becomes pregnant with your sperm, the baby may be exposed to Revlimid and may be born with birth defects. Men, if your female partner becomes pregnant, you should call your healthcare provider right away.
- Do not take Revlimid if you are allergic to anything in it.
- Do not share Revlimid with other people. It may cause birth defects and other serious problems.
- Do not donate blood while you take Revlimid, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping Revlimid.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Revlimid there are no specific foods that you must exclude from your diet when receiving Revlimid.
Tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or breastfeeding. Revlimid must not be used by women who are pregnant or breastfeeding. It is not known if Revlimid passes into your breast milk and harms your baby.
Revlimid may cause serious side effects including:
- Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take Revlimid.
- Revlimid is similar to the medicine thalidomide (Thalomid). We know thalidomide can cause severe lifethreatening birth defects. Revlimid has not been tested in pregnant women. Revlimid has harmed unborn animals in animal testing.
- for 4 weeks before starting Revlimid
- while taking Revlimid
- during any breaks (interruptions) in your treatment with Revlimid
- for 4 weeks after stopping Revlimid
- FDA MedWatch at 1-800-FDA-1088, and
- Celgene Corporation at 1-888-423-5436
Revlimid must not be used by breastfeeding women. It is not known if Revlimid is excreted in human breast milk or if it will harm your baby.
Take Revlimid exactly as prescribed and follow all the instructions of the RevAssist program. Before prescribing Revlimid, your healthcare provider will:
- explain the RevAssist program to you
- have you sign the Patient-Physician Agreement Form
- Swallow Revlimid capsules whole with water once a day. Do not break, chew, or open your capsules.
- Do not open the Revlimid capsules or handle them any more than needed. If you touch a broken Revlimid capsule or the medicine in the capsule, wash the area of your body with soap and water.
- If you miss a dose of Revlimid, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. 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.
- will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
- must agree to use 2 different forms of effective birth control at the same time, for 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping Revlimid.
Take Revlimid exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.
Multiple Myeloma: The recommended starting dose of Revlimid is 25 mg once daily on Days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings.
Myelodysplastic Syndromes: The recommended starting dose of REVLIMID is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Dose Adjustments for Hematologic Toxicities During MDS Treatment Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted. Also, patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted.
If you take too much Revlimid or overdose, call your healthcare provider or poison control center right away.
Revlimid capsules are available in the following strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, and 25 mg.
Inactive ingredients: 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.
Store Revlimid at room temperature, 59°F to 86°F (15°C to 30°C). Keep this and all medicines out of the reach of children.
WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
Do not use Revlimid during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. In women of childbearing potential, obtain 2 negative pregnancy tests before starting Revlimid® treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after Revlimid treatment. To avoid fetal exposure to lenalidomide, Revlimid is only available under a restricted distribution program called “RevAssist®” .
Information about the RevAssist program is available at www.Revlimid.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia) Revlimid can cause 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.
Deep Vein Thrombosis and Pulmonary Embolism Revlimid has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated with Revlimid and dexamethasone 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 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.