Thalidomide is used together with dexamethasone to treat multiple myeloma (bone marrow cancer). Thalidomide is also used to treat and prevent moderate to severe skin lesions caused by leprosy.

Thalidomide is available only in a 28-day supply from a certified pharmacy under a special program. You must be registered in the program and agree to use birth control as required.

Thalidomide may also be used for purposes not listed in this medication guide.

Never use thalidomide if you are pregnant. Even one dose of thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Both men and women using this medicine should use effective birth control to prevent pregnancy during treatment, and for up to 4 weeks after your last dose.

Thalidomide may cause blood clots. Stop using this medicine and call your doctor at once if you have symptoms such as sudden numbness, severe headache, problems with vision or speech, chest pain, shortness of breath, or swelling in your arm or leg.

Thalidomide comes as a capsule to take by mouth. Thalidomide is usually taken with water once a day at bedtime and at least 1 hour after an evening meal. If you are taking thalidomide to treat ENL, your doctor may tell you to take it more than once a day, at least 1 hour after meals. Take thalidomide at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take thalidomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Keep the capsules in their packaging until you are ready to take them. Do not open the capsules or handle them more than necessary. If your skin comes into contact with broken capsules or powder, wash the exposed area with soap and water.

The length of your treatment depends on how your symptoms respond to thalidomide and whether your symptoms return when you stop taking the medication. Your doctor may need to interrupt your treatment or reduce your dose if you experience certain side effects. Do not stop taking thalidomide without talking to your doctor. When your treatment is complete your doctor will probably decrease your dose gradually.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Never share thalidomide with another person.

Take thalidomide on an empty stomach, at least 1 hour after eating a meal. Swallow the capsule whole.

The medicine from an open capsule can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Your doctor will need to check your progress on a regular basis.

Store at room temperature away from moisture and heat. Keep each capsule in its blister pack until you are ready to take it. Do not allow another person to handle your medicine without wearing disposable gloves.

You should not use thalidomide if you are allergic to it.

Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one dose of thalidomide can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant. Tell your doctor right away if your period is late while taking thalidomide.

For Women: If you have not had a hysterectomy, you will be required to use two reliable forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking thalidomide. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking thalidomide, you will have a pregnancy test every 2 to 4 weeks.

Your birth control method must be proven highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth control you use must be a barrier method such as a condom, diaphragm, cervical cap, or contraceptive sponge.

Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

For Men: Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after you stop taking it. You must always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Call your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

Treatment with thalidomide may increase your risk of a blood clot or stroke during treatment for multiple myeloma. Ask your doctor about your specific risk.

Tell your doctor if you have ever had:

• heart disease, a stroke, or a blood clot;

• a seizure;

• if you need surgery; or

• if you also use pembrolizumab (Keytruda).

You should not breastfeed while using thalidomide.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

You must not donate blood or sperm while you are using thalidomide, and for at least 4 weeks after your last dose. Avoid exposing another person to your blood or semen through casual or sexual contact.

Avoid driving or hazardous activity until you know how thalidomide will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol can increase certain side effects of thalidomide.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Thalidomide may cause serious side effects. Call your doctor at once if you have:

• numbness, tingling, or burning pain in your hands or feet;

• slow heartbeats, shallow breathing, severe drowsiness, feeling like you might pass out;

• severe or ongoing constipation;

• a seizure (convulsions);

• signs of bleeding--easy bruising, nosebleeds, bleeding gums, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a stroke or blood clot--sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg;

• heart attack symptoms--chest pain spreading to your jaw or shoulder, nausea, sweating;

• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores; or

• signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your thalidomide doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects of thalidomide may include:

• fever;

• low blood cell counts;

• headache, dizziness, drowsiness, weakness, tired feeling;

• anxiety, agitation, confusion;

• numbness, tremors, muscle weakness;

• nausea, loss of appetite, constipation;

• weight gain or loss;

• swelling, trouble breathing;

• rash, dry or peeling skin; or

• low calcium level--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using thalidomide with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

If you use hormonal birth control (pills, implants, injections) to prevent pregnancy: There are certain drugs that can make hormonal birth control less effective in your body. Tell your doctor about all other medicines you use. You may need to replace your hormonal birth control method with another effective form of contraception.

Other drugs can affect thalidomide, and certain other medicines may further your increase your risk of blood clots. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to thalidomide.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.