Trade Name: Revlimid ^®

Drug Type:

Lenalidomide is classified as an "immunomodulatory agent" and an "antiangiogenic agent".  (For more detail, see "How Lenalidomide Works" section below.)

What lenalidomide Is Used For:

• Treatment of Multiple Myeloma
• Treatment of transfusion-dependent myelodysplastic syndrome (MDS) patients with deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 
• Treatment of Mantle Cell Lymphoma (MCL)
• In combination with a rituximab product for previously treated follicular lymphoma or marginal zone lymphoma

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Lenalidomide Is Given:

• Lenalidomide is taken as capsules by mouth.  Swallow whole with water. Do not break, chew, or open capsules.
• If you miss a dose of Lenalidomide, take it as soon as you remember that day.  If you miss taking your dose for the entire day, go back to taking your regular dose the next day.  Do not take 2 doses at the same time.
• Store Lenalidomide at room temperature, 59^o to 86^oF (15^o to 30^o C).
• In order to receive Lenalidomide, there are strict guidelines that you must follow.  You will be required to participate in a special program called the "RevAssist^sm program".
• Your doctor will determine your exact dosage and schedule.  Dosage may be adjusted based on your blood count results.

Side Effects:

Important things to remember about the side effects of Lenalidomide:

• You will not get all of the side effects mentioned below.
• Side effects are often predictable in terms of their onset, duration, and severity.
• Side effects are almost always reversible and will go away after therapy is complete.
• Side effects are quite manageable. There are many options to minimize or prevent them.

The following side effects are common (occurring in greater than 30%) for patients taking Lenalidomide:

• Low blood counts . Your white blood cells and platelets may temporarily decrease. This can put you at increased risk for infection and/or bleeding.  Blood counts are monitored closely and dose adjustments may be necessary. 
• Diarrhea
• Itching
• Rash
• Fatigue, tiredness

These are less common side effects for patients receiving Lenalidomide:

• Constipation
• Nausea
• Sore throat
• Generalized aches and pains 
• Fever 
• Back pain 
• Swelling of ankles or feet 
• Cough 
• Dizziness 
• Headache 
• Muscle cramps
• Shortness of breath   
• Generalized weakness
• Nose bleed 
• Infection
• Dry skin 
• Anemia (low red blood cell count)   
• Pneumonia 
• Low potassium 
• Difficulty sleeping 
• Poor appetite
• Vomiting  

A rare, but serious side effect of Lenalidomide is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus (PE).  You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath.  Notify your health care provider within 24 hours if you notice leg or arm swelling, redness, pain and/or skin warm to touch (signs and symptoms of possible blood clot)..

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately and notify your health care provider, it you experience the following symptoms:

• sudden chest pain and shortness of breath.

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools.
• Blood in the urine.
• Diarrhea (4-6 episodes in a 24-hour period).
• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Extreme fatigue (unable to carry on self-care activities).
• Leg or arm swelling, redness, pain and/or warm to touch.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Lenalidomide treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Lenalidomide.
• Lenalidomide is similar to the medication thalidomide a medication known to cause severe, life-threatening birth defects. Pregnancy category X (Lenalidomide may cause fetal harm when given to a pregnant woman. Lenalidomide must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking Lenalidomide, the medication must be stopped immediately and the woman given appropriate counseling).
• Women of childbearing potential will be treated only if they are able to comply with conditions of the RevAssist^SM program.  Two forms of effective contraception are required beginning 4 weeks prior to, during, and for 4 weeks after therapy and during therapy interruptions.
• Males (even those vasectomized) must use a latex condom during any sexual contact with women of childbearing age.  Risk to the fetus from semen of male patients is unknown.
• Do not breast feed while taking Lenalidomide.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your doctor while you are taking Lenalidomide, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor. For females of child-bearing potential (intact uterus, menstrual period within 24 months) a negative pregnancy test may be required monthly before the next month's prescription for Lenalidomide is given.

How Lenalidomide Works:

Lenalidomide's exact mechanism of action on cancer cells is not clear.  It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production.
 
In normal tissue, new blood vessels are formed during tissue growth and repair (i.e. a healing wound), and during the development of baby during pregnancy.  Blood vessels carry oxygen and nutrients to tissue that are necessary for growth and survival.  In cancer, tumors need blood vessels in order to grow and spread.  Through a complex process, endothelial cells (which line the blood vessels) are able to divide and grow and create new blood vessels.  This process is called angiogenesis and it occurs in both healthy tissue and in cancerous tissue.

Additionally, Lenalidomide is known to have various effects on the immune system (immunomodulatory agent), which may contribute to its therapeutic effect. Lenalidomide may also alter the production and activity of cytokines (growth factors) involved in the growth and survival of certain cancer cells.  There may be an effect on the genes that direct the cell's growth and activity particularly those associated with cytokines (growth factors), apoptosis (cell death), and metabolism.

Note:  We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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