Drug type: Thalidomide is classified as an “immunomodulatory agent,” and an “antiangiogenic agent.” (For more detail, see “How this drug works” section below).

What this drug is used for:

  • This medication has been approved by the FDA, for treatment of skin lesions associated with leprosy.
  • It has been under investigation for use in various cancer conditions such as: multiple myeloma, renal cell carcinoma, glioblastoma multiforme and Waldenströms macroglobulinemia. As well as treatment of graft vs. host disease (GVHD) after bone marrow transplant.
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 this drug is given:

  • As a capsule by mouth. Each capsule is 50 mg. Capsules should be stored in a cool, dry place and protected from light.
  • It is usually taken at night, about an hour before you go to bed, to decrease sleepiness during the daytime.
  • In order to receive this drug, there are strict guidelines that you must follow. You will be required to participate in a special program called the “System for Thalidomide Education and Prescribing Safety” (STEPS). You will be asked to fill out a questionnaire before you receive the medication, and every month, while you are taking the drug. Only certain pharmacists and doctors may prescribe or dispense this medication.

The amount of thalidomide you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dosage and schedule.

Side effects: Important things to remember about the side effects of thalidomide:

  • Most people do not experience all of the side effects listed.
  • Side effects are often predictable in terms of their onset and duration.
  • Side effects are almost always reversible and will go away after treatment is complete.

There are many options to help minimize or prevent side effects. There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

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

  • Severe life-threatening human birth defects if taken during pregnancy. (see precautions).
  • Sedative effects: fatigue, sleepiness, weakness, confusion, mood changes. You may develop tolerance to the sedative effects of thalidomide after several weeks of therapy.
  • Skin rashes; itching, redness, usually occurring over the trunk, back, arms and legs. It is important that all new rashes be reported to your health care professional immediately. If rash occurs thalidomide should be stopped and only restarted after evaluated by health care professional. Although rare, thalidomide may cause a severe skin reaction, called “Stevens-Johnson’s syndrome.”
  • Peripheral neuropathy: in the form of numbness, tingling and pain in the feet or hands. This side effect does not appear to be related to dose or length of time on thalidomide. If symptoms develop, evaluation takes place as to whether drug should be stopped. Symptoms often improve after drug is stopped, but may not resolve completely.
  • Constipation