Class: Biologic therapy

Generic Name: Thalidomide (the-LI-doe-mide)
Trade Name: Thalomid®

For which conditions is this drug approved? Thalidomide is FDA approved for the initial treatment of multiple myeloma, to be used in combination with dexamethasone. It is also approved for the treatment of skin nodules related to leprosy.  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 which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Thalidomide belongs to a group of agents called immunomodulators. Thalidomide produces its effects through several possible mechanisms. One mechanism may be through the interference of blood supply to cancer cells, ultimately inhibiting their ability to grow or spread. Other possible mechanisms involve the interference of some parts of the immune system that may be involved in the growth of cancer.

How is thalidomide typically given (administered)? Thalidomide is given orally, as a capsule and the dose depends on several factors, including the condition being treated, the particular regimen being used and the overall health of the patient. Thalidomide are typically given as a single bedtime dose.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with thalidomide.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
Patients will also typically be monitored for nerve damage (peripheral neuropathy) characterized by numbness, pain or tingling of the hands or feet. Female patients of childbearing age may also undergo frequent testing for pregnancy while being treated with thalidomide as this drug has been known to cause severe birth defects. Patients may have skin assessments, as thalidomide may cause a skin reaction referred to as Stevens-Johnson’s syndrome. Patients should report new rashes or other skin abnormalities to their healthcare provider.  Patients may also be monitored for allergic-type reactions to thalidomide, which may include shortness of breath or difficulty breathing, hives, closing of throat, wheezing or lightheadedness.

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

• Fatigue, weakness, sleepiness
• Skin abnormalities, rash
• Numbness, tingling or pain of the hands or feet
• Constipation

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

• Low levels of white blood cells – increases the risk of infection
• Dizziness when changing position from laying down to standing
• Swelling of the feet or ankles
• Headache
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 check with 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.)
• Some patients may be given medication to reduce constipation.

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 causes severe birth defects. It is important to use some kind 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.
• Women of childbearing potential must comply with mandatory pregnancy testing and use two reliable forms of contraception simultaneously.
• 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.
• Thalidomide may cause extreme drowsiness, dizziness or mental impairment so patients should exercise caution when driving or operating heavy machinery.
• Patients experiencing pain, tingling or numbness of the hands or feet should avoid extreme temperatures.
• Males being treated with thalidomide should always wear a condom if engaging in sexual activity.
• Patients should move from the laying position to the sitting position prior to standing, as this may reduce dizziness.
• Thalidomide may be harmful to children and pets. Store in a safe place. Return any unused medication to the pharmacy if you stop taking thalidomide treatment.
• Patients should not extensively handle or open the thalidomide capsules. Keep capsules in the blister packs until taking a dose.

When should patients notify their physician?

• Numbness, tingling or pain of the hands or feet
• Mental changes or impairment
• Skin abnormalities that occur while on treatment
• Sudden weight gain
• Swelling of feet or ankles
• Extreme fatigue
• Severe constipation
• Extreme dizziness
• Signs of infection – redness, swelling, pus, tenderness
• Signs of an allergic-type reaction, including shortness of breath or difficulty breathing, hives, closing of throat, wheezing or lightheadedness, skin rash or peeling

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 for 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 CancerConsultants Last updated 07/10.

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