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Generic Name: lenalidomide

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An antineoplastic - treats Anemia and Multiple Myeloma

FDA Alerts

Teratogenic Effects

Potential risk of teratogenicity and fetotoxicity due to structural similarity to thalidomide, a known human teratogen that can cause severe, life-threatening birth defects if administered during pregnancy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Teratogenicity Precautions

Contraindicated in pregnant women; use in women of childbearing potential only when alternative treatments are not available and adequate precautions taken to prevent fetal exposure. (See Contraindications and also Fetal/Neonatal Morbidity and Mortality under Cautions.)
Pregnancy must be excluded with 2 confirmed negative pregnancy tests (sensitivity to detect human serum chorionic gonadotropin [HCG] concentrations of ≥50 million IU/mL); one test within 10–14 days and another ≤24 hours prior to treatment initiation. Repeat pregnancy tests throughout therapy (i.e., once weekly during first month, then monthly or every 2 weeks in women with regular or irregular menstrual cycles, respectively).
Pregnancy must be prevented (even in females with a history of infertility) by simultaneous use of 2 forms of reliable contraception for ≥4 weeks prior to, throughout, and for 4 weeks after completion of therapy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Mandatory contraception not required for females who have undergone hysterectomy or bilateral oophorectomy, are postmenopausal and have had no menses for ≥24 consecutive months, or practice continuous abstinence from heterosexual contact.
Sexually mature males (including successfully vasectomized men) must completely avoid unprotected sexual contact with women of childbearing potential (i.e., use latex condom throughout and for ≥4 weeks after lenalidomide therapy) because it is unknown if drug distributes into semen.
Provide pregnancy tests and counseling if a patient misses her period or has abnormalities in menstrual bleeding.
If pregnancy occurs, immediately discontinue treatment. Refer patient to obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fetal exposure to FDA MedWatch Program at 1-800-FDA-1088 and to manufacturer at 1-888-423-5436.

Restricted Distribution Program

Available only through restricted distribution program, the RevAssist^® program, designed because of potential teratogenicity and to help ensure that fetal exposure does not occur. (See Restricted Distribution Program under Dosage and Administration.)
Limits access to lenalidomide to prescribing clinicians, pharmacies, and patients who are registered in program and mandates compliance with registration, education, and safety requirements.
Registered prescribing clinicians must understand risks of teratogenicity if used during pregnancy and must not provide a prescription until a documented negative pregnancy test available.
Patient or parent/legal guardian (for minors 12–18 years of age) must be capable of understanding and complying with patient registration, education, patient survey, and safety requirements, including mandatory contraceptive measures and pregnancy testing.
Provide oral and written warnings of risk of possible contraceptive failure, hazards of using drug during pregnancy, exposing fetus to drug, and possibility of drug in semen.
Patient or parent/legal guardian must provide written acknowledgement of understanding of these warnings and need for mandatory contraceptive measures.

Hematologic Toxicity

Risk of severe thrombocytopenia and neutropenia. (See Hematologic Effects under Cautions.)
Grade 3 or 4 neutropenia and/or thrombocytopenia reported in 80% of patients with myelodysplastic syndromes (MDS) with deletion 5q abnormality. Dosage delay or reduction required in 80% of such patients; a second dosage delay or reduction required in 34% of patients.
Monitor CBCs weekly for the first 8 weeks of therapy for MDS and at least monthly thereafter. Dosage interruption and/or reduction and supportive therapy (e.g., blood products) and/or hematopoietic agents (colony-stimulating factors) may be required. (See Dosage Modification for Toxicity in Patients with MDS under Dosage and Administration.)

Thromboembolic Effects

Increased risk of venous thromboembolism (e.g., DVT, PE) in patients with multiple myeloma when used in combination with dexamethasone. (See Thromboembolic Effects under Cautions.)
Monitor for signs and symptoms of thromboembolism.

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(len a LID o mide)

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 ifyou 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 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 purposes other than those listed in this medication guide.

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