Thalidomide capsules

What are thalidomide capsules?

THALIDOMIDE (Thalomid®) alters the body's immune response. Thalidomide is used to treat diseases and symptoms of diseases caused by abnormalities in the immune system. Thalidomide is also used to treat multiple myeloma. Thalidomide causes severe, life-threatening birth defects or death to an unborn child and is only available under strict guidelines. Both women and men must commit to strict guidelines when receiving thalidomide. To receive thalidomide, you, your physician, and your pharmacy must be registered in the System for Thalidomide Education and Prescribing Safety (STEPS) Program. You may only receive up to a 28-day supply of thalidomide at a time, and you will need a new prescription for each refill. Your prescription must be filled within 7 days of your doctor's office visit.

What should my health care professional know before I take thalidomide?

They need to know if you have any of these conditions:

• pregnant or planning to get pregnant

• breast-feeding or planning to breast-feed

• tingling or numbness in hands or feet or other nerve pain

• low white blood cell count

• low blood pressure

• seizure disorder (epilepsy)

• an unusual or allergic reaction to thalidomide other medicines, foods, dyes, or preservatives

How should I use this medicine?

Thalidomide capsules are taken by mouth with water. Make sure to follow the directions on your prescription bottle. If you are only taking thalidomide once a day, take your dose at bedtime at least 1 hour after the evening meal to decrease the drowsiness effects.

NEVER give this medicine to anyone else.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, consult your prescriber or health care professional. You may need to miss a dose or take a double dose, depending on your condition and treatment. Do not take double or extra doses without advice.

What drug(s) may interact with thalidomide?

• any medicines that may decrease the effectiveness of birth control pills

• any medicines which may cause tingling, numbness or nerve pain

Because thalidomide can cause drowsiness, other medicines that also cause drowsiness may increase this effect of thalidomide. Some medicines that cause drowsiness are:

• alcohol-containing medicines

• barbiturates such as phenobarbital

• certain antidepressants or tranquilizers

• muscle relaxants

• certain antihistamines used in cold medicines

Ask your prescriber or health care professional about other medicines that may increase the effect of thalidomide.

Tell your prescriber or other health care professional about all other medicines you are taking including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medications.

What should I watch for while taking thalidomide?

Thalidomide causes severe birth defects or death to an unborn child even after just ONE capsule. Both men and women must agree to take precautions against exposure of thalidomide to an unborn child. All patients will receive counseling about the potential birth defects and must agree to follow the conditions outlined in the System for Thalidomide Education and Prescribing Safety (STEPS) Program. The STEPS Program is a program to prevent exposure of thalidomide to an unborn child. The program involves required pregnancy testing, required birth control measures for men and women, doctor and patient education, registration of doctors, pharmacies and patients, and patient consent forms.

You may not donate blood while taking thalidomide. Men are not permitted to donate sperm while taking thalidomide.

Thalidomide has been associated with blood clots, especially when taken for multiple myeloma. Notify your healthcare provider immediately if develop shortness of breath, chest pain, or swelling in arms or legs. In some cases you may be given other medicine to help prevent blood clots while receiving thalidomide.

Thalidomide causes drowsiness that will decrease as you continue taking the medicine. Be careful driving or operating machinery while taking thalidomide. Take thalidomide at bedtime to decrease this effect.

Thalidomide may cause dizziness. Make sure to sit upright for a few minutes before standing up from a lying or seated position to avoid falling.

You should take a stool softener (docusate) or fiber-product to avoid constipation while taking thalidomide.

What side effects may I notice from receiving thalidomide?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• chest pain

• irregular menstrual bleeding

• missed menstrual cycle

• new or increased tingling or numbness in hands or feet

• muscle cramps

• rash associated with itching, blisters or open sores

• seizures

• shortness of breath

• numbness or tingling in arms or legs

• unusual swelling or pain in arms or legs

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• constipation

• drowsiness

• dizziness

• headache

Where can I keep my medicine?

Thalidomide may only be prescribed and dispensed by doctors and pharmacies registered in the STEPS program. Pharmacies may only fill a prescription if it is less than 7 days old and may only give you a 28-day supply.

Keep thalidomide out of reach of children and never share this medication with anyone. Return any unused thalidomide to the pharmacy where your prescription was filled. Your pharmacy will accept all unused thalidomide as part of the controlled distribution program.

Do not use beyond the expiration date on the package. Store this medicine at room temperature 59—86 degrees F (15—30 degrees C) and protect from light.