December 2, 2008


By Anonymous User

Class: Biologic Therapy

Generic Name: Lenalidomide (len-a-LID-oh-mide)
Trade Name: Revlimid®

For which conditions is this drug approved? Lenalidomide is FDA approved for the treatment of low or intermediate-1-risk myelodysplastic syndromes in patients who are transfusion-dependent because of anemia associated with their disease and those who have a deletion 5q cytogenetic abnormality. Lenalidomide is also approved for the treatment of multiple myeloma in patients who have received at least one prior therapy. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Lenalidomide is classified as both an immunomodulatory agent and an antiangiogenic agent. Lenalidomide’s mechanism of action remains to be fully discovered. However, it is known that lenalidomide modulates the immune system, which includes reducing several inflammatory responses that are implicated in the development and/or spread of cancer. In addition, lenalidomide inhibits the development of new blood vessels, reducing the ability of cancer cells to spread and replicate.

How is lenalidomide typically given (administered)? Lenalidomide is taken orally in the form of a tablet.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while being treated with lenalidomide. Physical examinations, scans, or evaluations may be performed to assess side effects and response to therapy. Blood may be drawn to measure levels of blood cells as well as to monitor functions of some organs, such as the kidney. In addition, patients will have their lungs monitored as a rare but serious side effect affecting the lungs may occur. If patients experience a sudden shortness of breath, cough and/or fever, they should contact their healthcare provider. Women of childbearing age will also undergo pregnancy testing prior to the use of lenalidomide, as well as routine pregnancy testing during treatment with lenalidomide.

What are the common side effects (occurring in 30% or more of patients) of treatment with lenalidomide?

  • Low levels of immune cells (neutropenia)—increases risk for infection
  • Low levels of platelets—increases risk for bleeding
  • Skin rashes, redness, etc.
  • Diarrhea
  • Fatigue

What are the less common side effects (occurring in 10% to 29% of patients) of treatment with lenalidomide?

  • Anemia—increases risk for need of blood transfusions
  • Constipation
  • Cough
  • Nausea
  • Inflammation of the throat and/or nasal passages
  • Shortness of breath
  • Vomiting
  • Bloody nose
  • Fluid retention
  • Fever
  • Pain: muscle, joint, abdominal, back, limb
  • Dizziness
  • Headache
  • Respiratory infections
  • Urinary infections
  • Insomnia
  • Changes in some laboratory values found upon blood draws

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should consult their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Maintain adequate rest and nutrition.
  • Wear sunscreen and protective clothing and try to minimize sun exposure.
  • Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
  • Eat small meals frequently to help alleviate nausea.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future. This drug may cause birth defects. It is important to use a form of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future since some drugs may cause fertility problems.
  • It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Patients should check with their physician before starting any new drug or nutritional supplement.
  • Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician? Patients should notify their physician when they experience the following:

  • Sudden onset of shortness of breath, cough, and/or fever
  • Any changes in breathing or pulse
  • Persistent or extreme diarrhea
  • Persistent or extreme nausea and vomiting
  • Possibility of pregnancy
  • Sudden chest pain or painful breathing
  • Swelling, redness of the leg, or pain upon movement of the leg
  • Difficulty, pain, or urgency in urinating
  • Sore throat
  • Continued swelling of the lower legs
  • Severe pain

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug by healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: Biological Therapy, L