Revlimid (lenalidomide)

Revlimid® (lenalidomide), an immunomodulatory drug (IMiD®), is the first oral medication that was developed for treatment of multiple myeloma. It is indicated for the treatment of adult patients with multiple myeloma in combination with dexamethasone, or as maintenance following autologous hematopoietic stem cell transplantation (ASCT).

How Does It Work?

Revlimid is an IMiD® compound that has immunomodulatory (affects the functioning of the immune system), tumoricidal (destroys tumor cells), and antiangiogenic (affects the blood vessels needed by tumors to grow) properties. It enhances the activity of immune cells—specialized white blood cells known as T cells and natural killer (NK) cells. Revlimid also:

• Helps immune system recognize and destroy myeloma cells.
• Targets and kills myeloma cells.
• Helps prevent new myeloma cell growth by starving myeloma cells of blood.

How Is Revlimid Given?

Revlimid is given as a once daily capsule that is swallowed with water. 

When Revlimid is prescribed with dexamethasone, the suggested dosing is based on a 28-day dosing cycle:

• Revlimid 25 mg every day for 21 days
• Dexamethasone 40 mg on days 1, 8, 15, and 22
• No Revlimid or dexamethasone on days 23-28

When Revlimid is used as maintenance therapy after ASCT, the dosing is also based on a 28-day dosing cycle:

• Revlimid 10 mg every day for 28 days
• After three cycles of therapy, the dose can be increased to 15 mg once daily based on your doctor’s recommendation and how you tolerate the medication.

Patients with kidney disease may take Revlimid, but the dosage must be adjusted according to the level of remaining kidney function, which is ascertained by a patient’s creatinine clearance value. 

Warnings and Precautions with Revlimid

Embryo-fetal toxicity

Revlimid may cause birth defects or death of an unborn baby. If you are a female, do not get pregnant and do not breastfeed.  

Revlimid can pass to human semen. If you are a male, do not donate sperm or have unprotected sexual contact with a female who is or could become pregnant.

Do not donate blood at any time during treatment and for 4 weeks after stopping Revlimid, incase your blood is given to a pregnant or breastfeeding female.

Neutropenia (low levels of neutrophils) and Thrombocytopenia (decreased platelet levels)

Revlimid causes low white blood cells (neutropenia) and low platelets (thrombocytopenia) in most people. You may need a blood transfusion or certain medicines, if your blood counts drop too low. Tell your doctor if you develop any bleeding or bruising during treatment. For more information, visit Myelosuppression.

Venous thromboembolism (VTE)

DVT is a blood clot (thrombus) in a deep vein of the lower extremities, usually occurring in the leg or thigh, very occasionally occurring 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 and is potentially life-threatening.

PE is a condition that occurs when a blood clot in the vein breaks loose, travels through the bloodstream, and lodges in a lung, blocking blood flow.

Blood clots in the arteries, veins, and lungs occur more often in people who take  Revlimid than in the healthy population. Patients with multiple myeloma who take Revlimid in combination with dexamethasone increase the risk of developing blood clots. Heart attacks and strokes are also more frequent in people who take Revlimid with dexamethasone. 

For more information on DVT, visit Heart and Lung Complications.

Serious Side Effects

The following serious side effects have been recorded in people taking Revlimid:

• increased risk of death in people who have chronic lymphocytic leukemia (CLL).
• risk of new cancers (malignancies).
• severe liver problems, including liver failure and death
• tumor lysis syndrome (TLS)
• worsening of your tumor (tumor flare reaction)
• thyroid problems
• risk of early death in mantle cell lymphoma (MCL)
• severe skin reactions and severe allergic reactions

Call your doctor right away if you experience a red, itchy rash; peeling of the skin or blisters; and/or severe itching; and fever.

Get emergency help immediately if you experience the following as you may be having an allergic reaction:

•     swelling of your lips, mouth, tongue, or throat
•     trouble breathing or swallowing
•     raised red areas on your skin (hives)
•     a very fast heartbeat
•     you feel dizzy or faint

Common Side Effects

You should contact your doctor if you have any side effects to this medication. The most common side effects are listed here:

• Diarrhea
• Itching and rash
• Nausea
• Constipation
• Tiredness or weakness
• Fever
• Swelling of the arms, hands, legs, feet, and skin
• Insomnia
• Headache
• Muscle cramps or spasms
• Shortness of breath
• Cough, sore throat, and other symptoms of the common cold
• Upper respiratory tract infection or bronchitis
• Inflammation of the stomach and intestine (also known as “stomach flu”)
• Nosebleed
• Shaking or trembling
• Joint aches
• Pain in your back or stomach

Revlimid and dexamethasone

It is important to be aware that additional toxicities can occur with this combination versus Revlimid alone. Side effects that may occur with Revlimid and dexamethasone include muscle weakness, anxiety, agitation, cardiac arrhythmias, nausea, increased blood sugar, elevated liver enzymes, and constipation and/or diarrhea. The use of dexamethasone in myeloma is discussed in a separate IMF booklet, Understanding Dexamethasone and Other Steroids.

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. To be eligible, patients must be receiving their first prescription of either Revlimid or Pomalyst, 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 InfoLine at 1-800-452-2873.