Revlimid® (lenalidomide)

REVLIMID®, a potent immunomodulatory derivative (IMiD) of thalidomide, induces apoptosis [programmed cell death] in resistant MM cell lines and patient cells and, more importantly, decreases binding of MM cells to bone marrow stromal cells. The compromise of this relationship between the myeloma cell and its microenvironment results in inhibiting production in the BM milieu of cytokines (IL-6, VEGF, TNF-alpha) mediating growth and survival of MM cells and blocking angiogenesis." (from "Myeloma therapy, from the bench to the clinic," Blood; November, 2002 (vol. 100, no.9, p. 3061)

General Information

Understanding Revlimid (lenalidomide) booklet

Revlimid® (lenalidomide) is an immunomodulatory drug that inhibits new blood vessel development on which cancer cells depend for sustenance and growth. Revlimid is the first oral medication that was developed for treatment of myeloma, and it is used in the newly diagnosed and relapsed and/or refractory settings.

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.

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 with Revlimid, 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 Revlimid.
  • 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 difficul passage of stools that persists for several weeks or longer.

Neutropenia 

Patients taking Revlimid may experience neutropenia, or low white blood cell count.

Thrombocytopenia (decreased platelet levels)

Patients taking Revlimid may experience thrombocytopenia, a lowered level of platelets in the blood. Platelets help blood to clot; fewer platelets can lead to bruising, bleeding, and slower healing.

Fatigue

Fatigue is commonly associated with Revlimid therapy. Although fatigue is generally not severe, caution is advised if you are operating machinery, including automobiles. For more information, please read a separate IMF booklet, Understanding Fatigue.

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.

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.

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.