Thalidomide Generic Name:
Thalidomide (tha-LID-oh-mide)Brand Name:
Thalidomide may cause severe birth defects or death of the fetus if used during pregnancy.
Women who are able to become pregnant and who take Thalidomide :
- 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 Thalidomide , while taking Thalidomide , and for 4 weeks after stopping Thalidomide ;
- must have a negative pregnancy test within 24 hours before starting Thalidomide ; and
- must have a pregnancy test every week for the first 4 weeks after starting Thalidomide and then every 2 to 4 weeks thereafter while taking Thalidomide .
Women who take Thalidomide and experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant must stop taking it and contact their doctor immediately.
Men who take Thalidomide :
- must either avoid sexual contact with women who are pregnant or could become pregnant while taking Thalidomide and for 4 weeks after stopping Thalidomide ; 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 Thalidomide and for 4 weeks after stopping Thalidomide , even if they have had a successful vasectomy.
Men who take Thalidomide and have unprotected sexual contact with a woman who is pregnant or may become pregnant, or who think for any reason that their sexual partner may be pregnant should contact their doctor immediately.
All patients who take Thalidomide :
- Thalidomide passes into semen. Female partners of men taking Thalidomide should call their doctor if they become pregnant.
- All patients must receive and understand all oral and written warnings about the risks of using Thalidomide .
- All patients must be able to follow the instructions for using Thalidomide and for using effective birth control methods if they are sexually active.
Use of Thalidomide in certain cancer patients increases their risk for blood clots in the arms, legs, or lungs. The risk is increased when it is used 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.
Thalidomide is used for:
Treating and preventing skin inflammation in patients who have moderate to severe erythema nodosum leprosum (ENL, leprosy). It is used with other medicines if the patient also has moderate to severe nerve inflammation due to ENL. It is also used with dexamethasone to treat patients who have a certain type of cancer (multiple myeloma).
Thalidomide 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 Thalidomide if:
- you are allergic to any ingredient in Thalidomide
- you are pregnant, planning to become pregnant, could become pregnant, or if you become pregnant during treatment with Thalidomide
- you are taking sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Thalidomide :
Some medical conditions may interact with Thalidomide . 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, unusual growth or tumors, cancer, low white blood cell count, or if you are on chemotherapy
- if you have a history of irregular menstrual periods, slow heartbeat, numbness or tingling in your hands or feet, blood clots, or seizures or epilepsy
Some MEDICINES MAY INTERACT with Thalidomide . 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 Thalidomide 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 Thalidomide :
Use Thalidomide 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 Thalidomide . Talk to your pharmacist if you have questions about this information.
- Thalidomide can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Thalidomide . Ask your doctor or pharmacist if you have any questions about this program or how to use Thalidomide .
- Take Thalidomide 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 Thalidomide more than necessary. Keep Thalidomide 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 Thalidomide , unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Thalidomide , while taking Thalidomide , and for 4 weeks after stopping Thalidomide . Talk with your doctor about which methods of effective birth control may be appropriate for you.
- Men who take Thalidomide 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 Thalidomide and for 4 weeks after stopping Thalidomide . This includes men who have had a vasectomy.
- Continue to use Thalidomide even if you feel well. Do not miss any doses.
- If you miss a dose of Thalidomide 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 Thalidomide .
Important safety information:
- Thalidomide may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Thalidomide 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 Thalidomide ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Thalidomide may cause dizziness, lightheadedness, or fainting when sitting up or standing; these effects may be increased by alcohol, hot weather, exercise, or fever. 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.
- Hormonal birth control (eg, birth control pills) may not work as well when taken with antibiotics or certain other medicines. Inform your doctor if you are taking antibiotics (eg, penicillin, amoxicillin, ampicillin), carbamazepine, an HIV-protease inhibitor (eg, ritonavir), griseofulvin, modafinil, phenytoin, rifabutin, or St. John's wort. Women requiring treatment with any of these medicines MUST use two other forms of birth control or abstain from sexual intercourse while using Thalidomide .
- Thalidomide is found in semen. Men who take Thalidomide must always use a latex condom during sexual contact with women who are pregnant or may become pregnant.
- Do not donate blood, semen, or sperm while taking Thalidomide or within 4 weeks after stopping Thalidomide .
- Thalidomide 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.
- Thalidomide 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, burning sensation, or pain in the hands, arms, legs, or feet.
- Thalidomide 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 Thalidomide . HIV-positive patients will need to have viral load measured regularly. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Thalidomide with caution in the ELDERLY; they may be more sensitive to its effects.
- Thalidomide 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 Thalidomide 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 Thalidomide , consult an obstetrician/gynecologist experienced in reproductive toxicity. It is unknown if Thalidomide is found in breast milk. Do not breast-feed while taking Thalidomide .
Possible side effects of Thalidomide :
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; hearing changes or hearing loss; mood or mental changes (eg, depression, suicidal thoughts or actions); mouth sores or irritation; neck pain or stiffness; pain or swelling in the arms or legs; red, swollen, blistered, or peeling skin; ringing in the ears or hearing changes; seizures; severe tiredness or weakness; shortness of breath; stiff neck; tremor; unusual bruising or bleeding; unusual swelling.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.Proper storage of Thalidomide :
Store Thalidomide 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 Thalidomide out of the reach of children and away from pets.
- If you have any questions about Thalidomide , please talk with your doctor, pharmacist, or other health care provider.
- Thalidomide 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 Thalidomide . 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.
- Thalidomide Professional Patient Advice (Wolters Kluwer)
- thalidomide Advanced Consumer (Micromedex) - Includes Dosage Information
- Thalomid Prescribing Information (FDA)
- Thalomid Consumer Overview