Thalidomide Oral capsule

What is this medicine?

THALIDOMIDE (tha LI doe mide) is used to treat multiple myeloma. It is also used to treat moderate to severe new lesions of leprosy and to prevent and keep the skin lesions of leprosy from coming back.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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

• human immunodeficiency virus (HIV)

• low blood pressure

• low white blood cell count

• seizure disorder

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

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

• pregnant or trying to get pregnant

• breast-feeding or planning to breast-feed

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. Do not cut, crush or chew this medicine. If you are only taking this medicine once a day, take your dose at bedtime at least 1 hour after your evening meal to decrease the drowsiness effects. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take

the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

• alcohol or any product that contains alcohol

• barbiturates, like phenobarbital

• certain antidepressants or tranquilizers

• certain antihistamines used in cold medicines

• medicines that may decrease the effectiveness of birth control pills

• medicines which may cause tingling, numbness or nerve pain

• muscle relaxants

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. You may need blood work done while you are taking this medicine.

This medicine is available only through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine. Through the program you will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill.

This medicine causes severe birth defects or death to an unborn child. This can happen after just ONE capsule. Both men and women must agree to take steps to prevent exposure of this medicine to an unborn child. Both men and women must use effective birth control with this medicine. Females with child-bearing potential will need to have 2 negative pregnancy tests before starting this medicine. Pregnancy testing must be done every 2 to 4 weeks as directed while taking this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 1 month after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away. Do not breast-feed an infant while taking this medicine.

Men must use a latex condom during sexual contact with a woman while taking this medicine and for 28 days after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for 28 days after you stop taking this medicine.

Do not give blood while taking the medicine and for 1 month after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• low blood counts - this medicine may decrease the number of white blood cells and platelets. You may be at increased risk for infections and bleeding

• pain, tingling, numbness in the hands or feet

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose; blood in the urine

• signs and symptoms of a blood clot such as breathing problems; chest pain; pain, swelling, warmth in the leg

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like dizziness; unusually slow heartbeat; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination

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

• constipation

• decreased appetite

• muscle cramps

• nausea

• swelling of the ankles, feet, hands

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children. Return any unused portion of this medicine to the pharmacy where your prescription was filled. Your pharmacy will accept all unused medicine as part of the controlled distribution program.

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Protect from light. Do not use any expired medicine.