Generic Name: thalidomide (tha-LID-oh-mide)
Brand Name: Thalomid
Do not take Thalomid if you are pregnant. It may cause severe birth defects or death of the fetus if used during pregnancy.
Women 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 test 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 taking Thalomid.
Women who take Thalomid 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 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
- use a latex or synthetic 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 take Thalomid 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 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 increased when it is used with certain other medicines, including dexamethasone. Contact your doctor right away if you develop shortness of breath; chest pain; or calf, leg, or arm pain, swelling, redness, or tenderness.
Thalomid 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).
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, or become pregnant during treatment with Thalomid
- you could become pregnant and are not using at least 2 forms of effective birth control or are not avoiding sexual contact with men
- 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 pregnant, planning to become pregnant, or 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, or a 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
- if you drink alcohol or are scheduled to have surgery
- if you also take medicine for mental or mood problems (eg, anxiety, depression)
- if you are taking any medicines that may increase the risk of blood clots. Ask your doctor or pharmacist if you are unsure if any of your medicines might increase the risk of blood clots
Some MEDICINES MAY INTERACT with Thalomid. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antihistamines (eg, diphenhydramine), opioid pain medicines (eg, oxycodone), or sodium oxybate (GHB) because the risk of severe drowsiness may be increased
- Alpha-blockers (eg, prazosin), beta-blockers (eg, atenolol), certain calcium channel blockers (eg, diltiazem, verapamil), digoxin, H2-blockers (eg, famotidine, cimetidine), lithium, or tricyclic antidepressants (eg, amitriptyline) because the risk of slow heartbeat may be increased
- Erythropoietic medicines (eg, epoetin alfa) or medicines that contain estrogen because they may increase the risk of blood clots
- Amiodarone, bortezomib, cisplatin, disulfiram, docetaxel, metronidazole, paclitaxel, phenytoin, vincristine, or other medicines that may cause nerve problems because the risk of nerve problems may be increased. Ask your doctor if you are unsure if any of your medicines might cause nerve problems
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.
- Thalomid comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Thalomid refilled.
- 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.
- Swallow Thalomid whole with water. Do not break, crush, or chew before swallowing.
- Take Thalomid by mouth at least 1 hour after eating your evening meal.
- 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 or synthetic 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, take it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. 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, or light-headedness. 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 while you are using Thalomid.
- Check with your doctor before you 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, light-headedness, 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, rifampin, or St. John's wort. Women requiring treatment with any of these medicines MUST use 2 other forms of birth control or abstain from sexual intercourse while using Thalomid.
- Do not donate blood, semen, or sperm 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 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.
- The chance of heart attack or stroke due to blood clots may be raised. Call your doctor right away if you have signs of heart attack like chest pain that may spread to the arms, neck, jaw, back, or stomach; sweating that is not normal; or feeling sick or throwing up. Call your doctor right away if you have signs of stroke like change in strength on 1 side is greater than the other; eyesight, speech, or balance problems; change in thinking clearly and with logic; or very bad headache.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Certain patients with cancer who take Thalomid have a risk of developing a serious and possibly fatal condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms, such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- Tell your doctor or dentist that you take Thalomid before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including complete blood cell counts, pregnancy tests, and nerve tests, may be performed while you use Thalomid. 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 Thalomid with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat, constipation, tiredness, nausea, low blood potassium levels, blood clots, high blood sugar, and weakness.
- Thalomid should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Thalomid if you are pregnant. It may cause severe birth defects or 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 not known 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; dry mouth or skin; headache; indigestion; light-headedness; loss of appetite; mild muscle or joint aches; nausea; tiredness; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, pain, or tingling of your hands, feet, arms, legs, or around the mouth or lips; changes in the amount of urine produced; dark urine; decreased sexual ability; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hearing loss or other hearing changes (eg, ringing in the ears); mood or mental changes (eg, agitation, anxiety, depression); mouth sores or swelling; muscle pain, weakness, cramping, or spasms; seizures; severe or persistent dizziness or light-headedness; severe or persistent nausea, vomiting, diarrhea, or loss of appetite; severe tiredness or weakness; suicidal thoughts or actions; swelling of the hands, ankles, or feet; tremor; unusual bruising or bleeding; unusual sweating; unusual weight changes.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Thalomid:
Store Thalomid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in the original packaging. Do not store in the bathroom. Keep Thalomid out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Thalomid or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Thalomid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Thalomid. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Thalomid.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.