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Revlimid® (lenalidomide), an immunomodulatory drug (IMiD®), is the first oral medication that was developed for treatment of multiple myeloma. It is used in the newly diagnosed, maintenance therapy, and relapsed and/or refractory settings.

How Does It Work?

Revlimid has multiple actions, including both anti-cancer and anti-inflammatory activities. It induces immune responses, prevents inflammation, and enhances the activity of immune cell—specialized white blood cells known as T cells and natural killer (NK) cells. Revlimid also prevents the formation of new blood vessels that cancer cells depend upon for sustenance and growth.

Possible Side Effects

Embroyo-fetal toxicitiy

Animal studies have shown that Revlimid can cause severe birth defects. To prevent severe birth defects from occurring as a result of pregnancy during treatment, the FDA required that a risk management program be established. The goals of the Revlimid Risk Evaluation and Mitigation Strategy (known as Revlimid REMS™) are as follows:

  • To prevent the risk of embryo-fetal exposure to the drug.
  • To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for Revlimid.

Constipation

Prevention is the key to managing constipation, which is defined as having fewer than three bowel movements a week. Chronic constipation is defined as infrequent bowel movements or difficult passage of stools that persists for several weeks or longer.

Neutropenia

Patients taking Revlimid may experience neutropenia, or low levels of our most abundant type of white blood cell, the neutrophil. White blood cells make up your immune system. Your immune system defends against viral and bacterial illnesses. Therefore, having too few of white blood cells can lead to infection. Fever is the most common sign of having too few neutrophils, and is a sign that you need immediate medical attention. Other common symptoms associated with a low neutrophil count include sore throat and mouth sores. For more information on neutropenia, visit Myelosuppression.

Thrombocytopenia (decreased platelet levels)

Patients taking Revlimid may experience thrombocytopenia, a lowered level of platelets in the blood. Platelets help blood to clot after an injury; fewer platelets can lead to bruising, bleeding, and slower healing. For more information on thrombocytopenia, visit Myelosuppression.

Fatigue

Fatigue is commonly associated with Revlimid therapy. Although fatigue is generally not severe, caution is advised if you are operating machinery, including automobiles. 

Deep-vein thrombosis

Deep-vein thrombosis (DVT) is a serious condition and is potentially life threatening. DVT is a blood clot in a deep vein of the lower extremities, usually occurring in the leg or thigh, and very occasionally in the neck or upper arm. A blood clot from a DVT can break loose (embolize) and travel to the heart or lungs. An embolus is very dangerous. If you start taking Revlimid and experience difficulty breathing, warmth, swelling, redness, and/or pain in an extremity, notify your doctor immediately. For more information on DVT, visit Heart and Lung Complications.

Rash

Rash is a serious concern. It is potentially dangerous, as a rash may be mild initially and then escalate in severity. Drug rashes vary in severity from mild redness with tiny bumps over a small area to peeling of the entire skin. Rashes may appear suddenly within minutes after a person takes a drug, or they may be delayed for hours or days

Additional Information

Revlimid prescribing information, including updated renal dosing guidelines

Dosing guidelines from the FDA and the EMA.

Patient Assistance

Celgene's patient support program

Celgene's Patient Support Coordinators assist patients and healthcare providers to navigate the challenges of reimbursement, provide information about co-pay assistance, and answer general questions about Revlimid.

Fast Track for First Prescription™

Celgene has developed a new program called Fast Track for First Prescription™ to help eligible patients receive their first prescriptions for a Celgene product quickly and efficiently. Fast Track is an optional service of Celgene Patient Support that facilitates communication between doctors, patients, insurance providers, risk management programs, pharmacies, and co-pay foundations. A Celgene Patient Support coordinator will ensure that “all the ducks are in a row” as quickly as possible, and remove the hurdles to accessing that first cycle of medication. To be eligible, patients must be receiving their first prescription of either Thalomid or Revlimid, must have documented proof of insurance, and must be registered in a Celgene risk management program and have a valid authorization number. For more information on the program, call the IMF Hotline at 800-452-2873.

Clinical Trials

Open Revlimid (lenalidomide) clinical trials

From the National Cancer Institute's clinicaltrials.gov, a list of the Revlimid trials that are currently recruiting patients.

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