Thalidomide Capsules

What is this medication?

THALIDOMIDE (tha LI doe mide) treats multiple myeloma, a type of bone marrow cancer. It works by slowing down the growth of cancer cells. It may also be used to prevent and treat skin conditions caused by leprosy. It works by slowing down an overactive immune system. This decreases inflammation.

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

COMMON BRAND NAME(S): Thalomid

What should I tell my care team before I take this medication?

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

• Human immunodeficiency virus (HIV)
• Low blood pressure
• Low white blood cell count
• Seizures
• Tingling or numbness in hands, feet, or other nerve pain
• An unusual or allergic reaction to thalidomide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. If you are taking this medication once a day, take your dose at bedtime at least 1 hour after your evening meal to decrease the drowsiness effects. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it 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 unless your next dose is to be taken in less than 12 hours. 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 medication?

• Alcohol or any product that contains alcohol
• Barbiturates, such as phenobarbital
• Certain antidepressants or tranquilizers
• Certain antihistamines used in cold medications
• Medications that may decrease the effectiveness of hormones used for contraception
• Medications 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 medication?

Visit your care team for regular checks on your progress. This medication 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 care team tells you to stop.

You may need blood work while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

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

Talk to your care team if you or your partner wish to become pregnant or think you might be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 4 weeks after the last dose. Avoid pregnancy for at least 4 weeks before beginning treatment, during treatment, during dose interruptions, and for at least 4 weeks after stopping treatment. Two negative pregnancy tests are required before starting this medication. A negative pregnancy test is also required periodically during treatment. Two reliable forms of contraception are required starting 4 weeks before treatment, during treatment, during dose interruptions, and for 4 weeks after treatment is stopped. Talk to your care team about reliable forms of contraception. Males must use a condom during sex while taking this medication and for 4 weeks after stopping treatment. A condom is needed even if you have had a vasectomy. If you become pregnant, miss a menstrual cycle, or stop using contraception, stop taking this medication. Call your care team. Severe birth defects may occur even if just 1 dose is taken.

Do not breast-feed while taking this medication.

Do not donate sperm while taking this medication or for 4 weeks after stopping treatment.

Do not donate blood while you are taking this medication or for 4 weeks after stopping treatment. Donated blood may contain enough of this medication to cause serious birth defects in a fetus if transfused to someone who is pregnant.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Infection—fever, chills, cough, or sore throat
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Pain, tingling, or numbness in the hands or feet
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

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

• Anxiety, nervousness
• Confusion
• Constipation
• Dizziness
• Drowsiness
• Fatigue
• Nausea
• Tremors or shaking

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 medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.