Thalomid affects the immune system. It promotes immune responses to help slow tumor growth.

Thalomid is used together with dexamethasone to treat multiple myeloma (bone marrow cancer).

Thalomid is also used to treat and prevent moderate to severe skin lesions caused by leprosy.

Thalomid is available only in a 28-day supply from a certified pharmacy under a special program called Thalomid REMS. You must be registered in the program and agree to use birth control as required. You will be limited to a 28-day supply of medicine each time your prescription is refilled.

Never use Thalomid 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.

Thalomid 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.

Take Thalomid exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Never share this medicine with another person, even if they have the same disorder you have.

Take Thalomid 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.

Usual Adult Dose of Thalomid for Leprosy -- Erythema Nodosum Leprosum:

Cutaneous erythema nodosum leprosum (ENL):
Initial dose: 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; patients less than 50 kg should be started at the low end of the dose range

Initial dose: Up to 400 mg/day orally once a day at bedtime or in divided doses with water, at least 1 hour after meals

Usual Adult Dose of Thalomid for Multiple Myeloma:

200 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal

-thalidomide is administered in combination with dexamethasone in 28-day treatment cycles. The dexamethasone dose is 40 mg orally on days 1 through 4, 9 through 12, and 17 through 20 every 28 days.

Approved indication: In combination with dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma.

Usual Pediatric Dose of Thalomid for Leprosy -- Erythema Nodosum Leprosum:

12 years or older:
Cutaneous erythema nodosum leprosum (ENL):
Initial dose: 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; patients less than 50 kg should be started at the low end of the dose range

Severe cutaneous ENL reaction or patients previously requiring higher doses to control the reaction:
Initial dose: Up to 400 mg/day orally once a day at bedtime or in divided doses with water, at least 1 hour after meals

Comments:
-In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with thalidomide; steroid usage can be tapered and discontinued when the neuritis has ameliorated. Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
-In general, dosing should continue until active reaction subsides (usually at least 2 weeks), then tapered in 50 mg decrements every 2 to 4 weeks.
-Patients with a history of requiring prolonged maintenance to prevent recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Approved indications: For the acute treatment of cutaneous manifestations of moderate to severe ENL and as maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence.

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

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 Thalomid.

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 Thalomid and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking Thalomid. 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 this medicine, 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, a diaphragm, a cervical cap, or contraceptive sponge.

Stop using Thalomid 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 Thalomid may increase your risk of a blood clot or stroke during treatment for multiple myeloma. Ask your doctor about your specific risk.

To make sure Thalomid is safe for you, 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.

You must not donate blood or sperm while you are using Thalomid, 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 this medicine 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 Thalomid.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Thalomid (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.

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;

• a seizure (convulsions);

• severe or ongoing constipation;

• 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 Thalomid doses may be delayed or permanently discontinued if you have certain side effects.

Common Thalomid side effects 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 Thalomid 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 interact with 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.