Treats and prevents recurrence of ENL (erythema nodosum leprosum), a painful skin problem caused by Hansen's disease (leprosy). This medicine also treats newly-diagnosed multiple myeloma (plasma cell cancer) when taken with dexamethasone.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
This medicine can cause serious or life-threatening birth defects in unborn babies. You should not use this medicine if you are pregnant or breastfeeding, or if you may become pregnant during treatment. You should not use this medicine if you have had an allergic reaction to thalidomide.
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- Do not open the blister pack that contains the capsule until you are ready to take it.
- You will be asked to sign a consent and agreement form before you take this medicine. This form tells you about the risks of using this medicine and the guidelines for safe use. Make sure you understand what is on the form before you sign it. You will also be asked to take part in a telephone survey and have your name placed on a patient registry list. If you have any questions ask your doctor.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows about ALL other medicines you are using. This is especially important if you are a woman taking birth control pills while you are using thalidomide. Some medicines can cause birth control pills not to work as well to prevent pregnancy, and you should not take thalidomide if you get pregnant.
- Make sure your doctor knows if you are also using any other medicine that might cause nerve problems.
- Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
- Do not drink alcohol while you are using this medicine.
Warnings While Using This Medicine
- Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
- Use two forms of effective birth control to avoid pregnancy for 4 weeks before you start using thalidomide, during your treatment (even during times when treatment is temporarily stopped), and for at least 4 weeks after your treatment ends. This is very important whether you are a man or a woman. The most effective forms of birth control include birth control pills or implants, a diaphragm or cervical cap, an IUD, tubal ligation (for women), or vasectomy and a condom (for men).
- If you are a woman who can get pregnant, your doctor will do tests to make sure you are not pregnant before starting thalidomide therapy. These tests may be done weekly for the first month, and then every month if you have regular menses or every 2 weeks if you have irregular menses. If you are a man, you should use a latex condom every time you have sexual intercourse with a woman who could possibly get pregnant. You must use a latex condom even if you have had a vasectomy.
- Make sure your doctor knows if you have any history of seizure disorder or heart disease, or if you have a severe infection, such as HIV.
- This medicine may increase your risk of having blood clotting problems or serious skin disorders. Tell your doctor right away if you develop symptoms such as shortness of breath, chest pain, arm or leg swelling, or any new skin rash while using this medicine.
- Thalidomide may cause nerve damage. If you have any numbness, tingling, burning, or pain in the hands or feet, call your doctor right away.
- You must not share this medicine with anyone, even someone who has similar symptoms.
- Do not donate blood or sperm while you are using thalidomide.
- This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may feel lightheaded when standing, so stand up slowly.
- This medicine may lower the number of some types of blood cells. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Absence of menstruation, or late or missed menstrual period.
- Blistering, peeling, red skin rash.
- Change in how much or how often you urinate.
- Chest pain, shortness of breath, or coughing up blood.
- Confusion, weakness, and muscle twitching.
- Dry mouth, increased thirst or hunger, muscle cramps, nausea or vomiting.
- Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
- Lightheadedness, dizziness, drowsiness, or fainting.
- Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
- Pain in your lower leg (calf).
- Red or dark brown urine.
- Seizures or tremors.
- Slow, uneven, or fast, pounding heartbeat.
- Sudden or severe stomach pain, constipation, diarrhea, or upset stomach.
- Swelling in your face, hands, ankles, or feet.
- Trouble breathing or swallowing.
- Unusual bleeding or bruising.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Breast enlargement (in males).
- Changes in vision, or red, irritated eye.
- Headache, toothache, bone pain, muscle pain, or joint pain.
- Loss of appetite.
- Mild nail or skin changes, such as skin rash, itching, or dryness.
- Problems having sex.
- Sores or white patches on your lips, mouth, or throat.
- Tiredness, depression, or memory problems.
- Trouble sleeping, nervousness, agitation, or anxiety.
- Weight gain or weight loss.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04