Thalidomide

Thalidomide is used 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 reasons not mentioned in this medication guide.

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 happens, 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 regularly.

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.

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.

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

Thalidomide can cause serious, life-threatening birth defects or death of a baby if either parent is taking this medicine at the time of conception or during pregnancy. Even one dose of thalidomide can lead to major birth defects in the baby's arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant. Inform your doctor immediately if your period is late while taking thalidomide.

For Women: If you have not had a hysterectomy, you must use two reliable forms of birth control starting 4 weeks before you begin taking thalidomide and continuing for 4 weeks after you stop taking it. This requirement applies even if you have fertility issues. You will also need to have a negative pregnancy test 10 to 14 days before treatment and again 24 hours before treatment starts. While taking thalidomide, you will have a pregnancy test every 2 to 4 weeks.

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

Stop using thalidomide and call your doctor immediately if you stop 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 way to prevent 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 can get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if you think your female partner may be pregnant.

Treatment with thalidomide may increase your risk of a blood clot or stroke while being treated 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.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble 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 right away if you have:

• numbness, tingling, or burning pain in your hands or feet;
• slow heartbeats, shallow breathing, severe drowsiness, feeling like you might faint;
• 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 stopped if you have certain side effects.

Common side effects of thalidomide may include:

• fever;
• low blood cell counts;
• headache, dizziness, drowsiness, weakness, feeling tired;
• 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 tingling 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.

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

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

You must not donate blood or sperm while 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 doing any hazardous activity until you know how thalidomide will affect you. Your reactions could be impaired. Avoid getting up too quickly from a sitting or lying position, or you may feel dizzy.

Drinking alcohol can increase certain side effects of thalidomide.

Using thalidomide with other medications that cause drowsiness can make you feel even more tired. Consult 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: Some drugs can reduce how well hormonal birth control works in your body. Inform your doctor about all other medicines you are taking. You may need to switch your hormonal birth control method to another effective form of contraception.

Other medications can affect thalidomide, and some may increase your risk of blood clots. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are mentioned here. Inform your doctor about all your current medicines and any new medicine you start or stop using.