Lenalidomide

Lenalidomide is a prescription medication used to treat myelodysplastic syndrome (MDS, bone marrow that does not produce enough mature blood cells). Lenalidomide is also used to treat multiple myeloma and mantle cell lymphoma (MCL). 

Lenalidomide 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 lenalidomide capsules whole.

Common side effects include diarrhea, itching, and rash.

Lenalidomide 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.

Lenalidomide is also used with dexamethasone to treat people with multiple myeloma.

Lenalidomide is also approved to treat those with multiple myeloma after autologous stem cell transplant (a type of stem cell transplant that uses your own stem cells).

This medication is also used to treat patients with mantle cell lymphoma (MCL) whose disease has relapsed or worsened after two prior therapies, one of which included bortezomib (Velcade).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Lenalidomide may be found in some form under the following brand names:

• Revlimid

Lenalidomide may cause serious side effects. See "Lenalidomide Precautions" section.

Common side effects include:

• diarrhea
• itching
• rash
• tiredness

These are not all the possible side effects of lenalidomide. 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).

Lenalidomide may cause serious side effects.

• Serious skin reactions. Serious skin reactions can happen with lenalidomide and may cause death. Call your healthcare provider right away if you have any skin reaction while taking lenalidomide.
• 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.


Do not take lenalidomide if you are pregnant, plan to become pregnant, or become pregnant during lenalidomide treatment and for 4 weeks after stopping lenalidomide treatment. See FDA Warning.

• For 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 lenalidomide, during any breaks (interruptions) in your treatment with lenalidomide, and for 4 weeks after stopping lenalidomide. (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 lenalidomide, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping lenalidomide. If a female becomes pregnant with your sperm, the baby may be exposed to lenalidomide 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 lenalidomide if you are allergic to anything in it.

Do not share lenalidomide with other people. It may cause birth defects and other serious problems.

Do not donate blood while you take lenalidomide, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping lenalidomide.

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 lenalidomide there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to lenalidomide or to any of its ingredients.
• are pregnant or breastfeeding. Lenalidomide must not be used by women who are pregnant or breastfeeding. 

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Lenalidomide 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 provider and pharmacist.

Lenalidomide 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 lenalidomide. 
• Lenalidomide is similar to the medicine thalidomide (Thalomid). We know thalidomide can cause severe life-threatening birth defects. Lenalidomide has not been tested in pregnant women. Lenalidomide has harmed unborn animals in animal testing.

To avoid fetal exposure to lenalidomide, lenalidomide is only available under a restricted distribution program called Revlimid REMS .

• 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 lenalidomide.

Females must not get pregnant:

• for 4 weeks before starting lenalidomide
• while taking lenalidomide
• during any breaks (interruptions) in your treatment with lenalidomide
• for 4 weeks after stopping lenalidomide

If you become pregnant while taking lenalidomide, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to:

• FDA MedWatch at 1-800-FDA-1088

It is not known if lenalidomide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using lenalidomide.

• Take lenalidomide exactly as prescribed.
• Swallow lenalidomide capsules whole with water once a day. Do not break, chew, or open your capsules.
• Do not open the lenalidomide capsules or handle them any more than needed. If you touch a broken lenalidomide capsule or the medicine in the capsule, wash the area of your body with soap and water.
• If you miss a dose of lenalidomide, 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 lenalidomide or overdose, call your healthcare provider or poison control center right away.

Take lenalidomide 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 lenalidomide 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.

Multiple Myeloma following autologous stem cell transplant:Revlimid 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles.

Myelodysplastic Syndromes: The recommended starting dose of lenalidomide 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.

Mantle Cell Lymphoma: The recommended dose of lenalidomide 25 mg by mouth, once daily on days 1-21 of repeated 28-day cycles. 

If you take too much lenalidomide or overdose, call your healthcare provider or poison control center right away.

• Store lenalidomide 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 lenalidomide 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 lenalidomide treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide treatment. To avoid fetal exposure to lenalidomide, lenalidomide is only available under a restricted distribution program called “Revlimid REMS” .

Information about the Revlimid REMS program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia) lenalidomide 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 lenalidomide has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated with lenalidomide 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 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.