MEDICAL INFORMATION FOR HEALTH CARE PROFESSIONALS

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THALIDOMIDE

Other names: Synovir®

WHY is this medication prescribed ?

Thalidomide was once widely used during pregnancy to relieve morning sickness. While it is no longer used for this purpose, it is potentially useful in the treatment of several AIDS-related conditions, including weight loss and wasting, and ulcers (anal, mouth, and/or throat) of unknown cause.

Thalidomide is also used in the management of other immune diseases such as lupus, rheumatoid arthritis and graft versus host disease (in people receiving bone marrow transplants). Thalidomide is currently being investigated for other indications as well.

HOW should this drug be taken ?

The dosage range may vary from 100 to 300 mg daily. Since each person responds differently to medical treatments, your doctor will recommend the dose and duration of therapy that is best for you.

Thalidomide should be taken in the late afternoon or before bedtime since it may cause drowsiness.

What should you do if you FORGET a dose?

If you forget to take a dose, take it as soon as you remember, unless it is close to the time of the next dose. Do not double the dose, just carry on with your regular dosing schedule. Always check to ensure that the drug has not expired before using it, especially if you have missed a dose.

What ADVERSE EFFECTS can this drug cause ? What should you do about them?

The most serious side effect of thalidomide is the potential to cause birth defects. It was found to cause deformed limbs in the children of women who took the drug early in pregnancy. Appropriate birth control methods (e.g., birth control pill plus barrier method for women, condoms for men) must be used by people of child-bearing age who are taking thalidomide.

Thalidomide can cause drowsiness or sedation; if this is a problem for you, you may wish to take your dose late in the day or before bedtime.

Long term use can cause peripheral neuropathy, which may lead to symptoms such as tingling, burning, pain, or numbness in the hands and feet. If this occurs, your thalidomide dosing may need to be reduced or stopped.

Some people may experience allergic reactions to medicines. If you have any of the following symptoms soon after taking thalidomide, STOP taking the drug and tell your doctor IMMEDIATELY: sudden wheeziness and chest pain or tightening, swelling of eyelids, face or lips, skin rash or "hives" anywhere on the body.

IT IS IMPORTANT THAT YOU KEEP YOUR DOCTOR AND LABORATORY APPOINTMENTS, SO THAT YOUR PROGRESS CAN BE ASSESSED REGULARLY.

IF YOU ARE EXPERIENCING ANY ADVERSE EFFECTS, PLEASE DISCUSS THEM WITH YOUR HEALTH CARE TEAM.

What other PRECAUTIONS should you follow while using this drug ?

Before beginning treatment with thalidomide, make sure your doctor knows if· you are pregnant, plan on becoming pregnant, or are breast-feeding a child.

· women should have pregnancy tests performed regularly (up to every week if necessary), and for 4 weeks after stopping thalidomide

This information will help you and your physician decide if the potential benefits of treating your condition with thalidomide will outweigh the possible risks.

How should this medication be STORED?

Thalidomide should be kept at room temperature (2-30oC). Do not store in your bathroom or kitchen as heat and moisture may cause the medication to lose potency.

KEEP THIS AND ANY OTHER DRUGS OUT OF SIGHT AND OUT OF REACH OF CHILDREN.

IF YOU HAVE ANY QUESTIONS OR CONCERNS ABOUT THIS MEDICATION, PLEASE DISCUSS THEM WITH YOUR PHARMACIST, PHYSICIAN, OR NURSE.

WRITE DOWN QUESTIONS OR CONCERNS TO MAKE SURE THEY ARE ADDRESSED.

A pharmacist at ___________________ is available to answer questions.

The telephone number is ___________ Please ask for ____________________

Adapted from the Synovir®Product Monograph. Edited by the CSHP Ont. Branch Professional Specialty Group in HIV Disease in conjunction with the HIV/AIDS Outpatient Network Coordinators Sub-Group, 1997.