Thalomid

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Thalomid


Generic Name: Thalidomide (tha-LID-oh-mide)
Brand Name: Thalomid

Thalomid may cause severe birth defects or death of the fetus if used during pregnancy.

Females who are able to become pregnant and who take Thalomid :

  • must not become pregnant;
  • must either avoid sexual contact with men or use at least 2 forms of effective birth control for 4 weeks before starting Thalomid , while taking Thalomid , and for 4 weeks after stopping Thalomid ;
  • must have a negative pregnancy within 24 hours before starting Thalomid ; and
  • must have a pregnancy test every week for the first 4 weeks after starting Thalomid and then every 2 to 4 weeks thereafter while using Thalomid .

Women who experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant while taking Thalomid must stop taking it and contact their doctor immediately.

Males who take Thalomid :

  • must either avoid sexual contact with women who are pregnant or could become pregnant while taking Thalomid and for 4 weeks after stopping Thalomid ; OR
  • must use a latex condom during sexual contact with women who are pregnant or could become pregnant for as long as they are taking Thalomid and for 4 weeks after stopping Thalomid , even if they have had a successful vasectomy.

Men who have unprotected sexual contact with a woman who is pregnant or may become pregnant or who thinks for any reason that their sexual partner may be pregnant should contact their doctor immediately.

All patients who take Thalomid :

  • Thalomid passes into semen. Female partners of men taking Thalomid should call their doctor if they become pregnant.
  • All patients must receive and understand all oral and written warnings about the risks of using Thalomid .
  • All patients must be able to follow the instructions for using Thalomid and for using effective birth control methods if they are sexually active.

Use of Thalomid in certain cancer patients increases their risk for blood clots in the arms, legs, or lungs. The risk is greater when it is used along with certain other medicines, including dexamethasone. Contact your doctor right away if you develop shortness of breath, chest pain, calf pain or tenderness, or swelling of an arm or leg.


Thalomid is used for:

Treating skin inflammation in patients who have moderate to severe erythema nodosum leprosum (ENL, leprosy) and to prevent it from coming back. It is used along with other medicines if the patient also has moderate to severe nerve inflammation due to ENL. It is also used along with dexamethasone to treat patients who have a certain type of cancer (multiple myeloma).

Thalomid is an immunomodulatory agent. It works on the immune system to decrease certain substances that cause skin inflammation in patients who have ENL. In cancer patients, it appears to increase certain natural substances that help to kill cancer cells.

Do NOT use Thalomid if:

  • you are allergic to any ingredient in Thalomid
  • you are pregnant, planning to become pregnant, could become pregnant, or become pregnant during treatment with Thalomid
  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Thalomid :

Some medical conditions may interact with Thalomid . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have HIV infection
  • if you have a history of irregular menstrual periods, low white blood cell count, slow heartbeat, numbness or tingling in your hands or feet, blood clots, seizures or epilepsy, unusual growths or tumors, certain inflammatory conditions, or cancer

Some MEDICINES MAY INTERACT with Thalomid . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Barbiturates (eg, phenobarbital), phenothiazines (eg, chlorpromazine), reserpine, or sodium oxybate (GHB) because the risk of severe drowsiness may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Thalomid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Thalomid :

Use Thalomid as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with this medicine. Talk to your pharmacist if you have questions about this information.
  • Thalomid can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Thalomid . Ask your doctor or pharmacist if you have any questions about this program or how to use Thalomid .
  • Take Thalomid with water at least 1 hour after eating.
  • If you are taking 1 dose daily, take it at bedtime, unless your doctor tells you otherwise.
  • Do not open the capsules or handle Thalomid more than necessary. Keep Thalomid in the blister pack until just before you are ready to take it. If you touch a capsule that has been opened or get the powder on your skin, wash the area with soap and water right away.
  • Women who are able to become pregnant (including those who have started menopause within the last 24 months), must use at least 2 methods of effective birth control while taking Thalomid , unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Thalomid , while taking Thalomid , and for 4 weeks after stopping Thalomid . Talk with your doctor about which methods of effective birth control may be appropriate for you.
  • Men who take Thalomid must use a latex condom during any sexual contact with a woman who is pregnant or could become pregnant for as long as they are taking Thalomid and for 4 weeks after stopping Thalomid . This includes men who have had a vasectomy.
  • Continue to use Thalomid even if you feel well. Do not miss any doses.
  • If you miss a dose of Thalomid and you are taking 1 dose daily at bedtime, skip the missed dose and go back to your regular dosing schedule. Do not take the missed dose in the morning. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Thalomid .

Important safety information:

  • Thalomid may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Thalomid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Thalomid ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Thalomid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Inform your doctor if you are taking an HIV-protease inhibitor (eg, ritonavir); griseofulvin, rifampin, rifabutin, penicillin, amoxicillin, ampicillin, or other antibiotic medicines; St. John"s wort; modafinil; phenytoin; or carbamazepine. These medicines may decrease the effectiveness of hormonal contraceptives (eg, birth control pills).
  • Do not donate semen, sperm, or blood while taking Thalomid or within 4 weeks after stopping Thalomid .
  • Thalomid may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Thalomid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Thalomid . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Thalomid may cause nerve damage. Symptoms may develop during treatment or after treatment is stopped. Symptoms of nerve damage may resolve slowly over time but may be permanent in some cases. Contact your doctor right away if you develop symptoms of numbness, tingling, or pain in the hands, arms, legs, or feet.
  • Thalomid may increase the risk of blood clots in certain patients. Call your doctor at once if you notice shortness of breath; chest pain; or pain, tenderness, or swelling in an arm or leg.
  • Lab tests, including pregnancy tests, complete blood cell counts, and nerve tests, may be performed while you use Thalomid . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Thalomid with caution in the ELDERLY; they may be more sensitive to its effects.
  • Thalomid should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Use of Thalomid during pregnancy has resulted in severe birth defects and death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor at once. If you become pregnant while using Thalomid , consult an obstetrician/gynecologist experienced in reproductive toxicity. It is unknown if Thalomid is found in breast milk. Do not breast-feed while taking Thalomid .

Possible side effects of Thalomid :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; headache; nausea; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, pain, or tingling of your hands, feet, arms, legs, or around the mouth or lips; calf pain or tenderness; chest pain; dark urine; decreased sexual ability; eye pain or vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; mood changes; mouth sores or irritation; neck pain or stiffness; pain or swelling in the arms or legs; red, swollen, or blistered skin; ringing in the ears or hearing changes; seizures; severe tiredness or weakness; shortness of breath; stiff neck; swelling of an arm or leg; tremor; unusual bruising or bleeding; unusual swelling.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Thalomid :

Store Thalomid at 77 degrees F (25 degrees C) in the original packaging. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep Thalomid out of the reach of children and away from pets.

General information:

  • If you have any questions about Thalomid , please talk with your doctor, pharmacist, or other health care provider.
  • Thalomid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Thalomid . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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