Women who are pregnant must not use thalidomide. Women must avoid becoming pregnant while taking this medication. Even a single dose of thalidomide has caused severe (often fatal) birth defects when used during pregnancy. You must have a negative pregnancy test 24 hours before you start treatment with thalidomide, repeating the test at least monthly. Do not start or continue thalidomide treatment unless you have a negative pregnancy test result.
Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 1 month before starting thalidomide, during use, and for 1 month after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor immediately. (See also Precautions section.)
Because thalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Continue using condoms and other birth control as directed until 1 month after thalidomide treatment has been stopped.
Only patients who have signed an informed consent and agree to the requirements of the STEPS program may obtain and use thalidomide. Only physicians enrolled in STEPS may prescribe thalidomide, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the STEPS program and for more information about the risks and benefits of using this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
When used to treat a certain type of cancer (multiple myeloma), thalidomide can increase the risk of serious blood clots in the legs or lungs, as well as heart attacks and strokes. Seek immediate medical attention if you develop shortness of breath, chest pain, jaw/neck/left arm pain, weakness on one side of your body, slurred speech, sudden vision changes, or arm/leg swelling. While you are taking thalidomide, your doctor may also direct you to take aspirin or other "blood thinners" (e.g., warfarin) to lessen the risk of these types of blood clots. Talk to your doctor for more information, and tell him/her if you have diabetes, high blood pressure or high cholesterol, kidney problems, or if you smoke. (See also Side Effects section.)Who should not take thalidomide?
This medication is used to treat or prevent certain skin conditions related to Hansen's disease, once known as leprosy (erythema nodosum leprosum). Thalidomide is also used with other drugs to treat a certain type of cancer (multiple myeloma). Thalidomide belongs to a class of drugs known as immunomodulators. It works in Hansen's disease by reducing swelling and redness (inflammation). It also reduces the formation of blood vessels that feed tumors.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using thalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
Keep the capsules in their blister pack until ready to use. Do not open or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.
This medication passes into body fluids (e.g., urine). Avoid contact with body fluids from people taking this drug. Therefore, wear protective clothing (e.g., gloves) when handling these body fluids (e.g., during cleanup). If contact occurs, wash skin with soap and water.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication for Hansen's disease, your skin condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.
Tell your doctor if your condition does not improve or if it worsens after 2 weeks.
See also Warning section.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Thalidomide may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment has stopped. Tell your doctor immediately if you develop any of the following symptoms: numbness/tingling/pain/burning in the feet or hands, muscle weakness/cramps, feeling of tightness in the feet.
People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia). Consult your doctor for more details.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, anxiety), shaking (tremor), shortness of breath, arm/leg swelling, fast/slow heartbeat, signs of infection (e.g., fever, persistent sore throat).
Get medical help right away if you have any very serious side effects, including: seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking thalidomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (neutropenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: numbness/tingling of arms/legs, seizures.
Caution is advised when using this drug in people with HIV because they may be more sensitive to the effects of the drug. While thalidomide is used to treat muscle wasting and other HIV-related conditions, the drug might affect the amount of HIV in your system (viral load). Therefore, the manufacturer recommends having HIV tests from time to time.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.
Thalidomide must not be used during pregnancy due to the risk of severe birth defects and other serious, sometimes fatal harm to an unborn baby. If you are female and become pregnant or think you may be pregnant, if your period is late or you have unusual menstrual bleeding, or if you stop using 2 forms of birth control, stop taking thalidomide and tell your doctor immediately. If you are male and have had unprotected sex with a woman who can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors immediately. (See also Warning section.)
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may cause nerve damage (e.g., certain HIV drugs including didanosine/zalcitabine, certain cancer drugs including paclitaxel/cisplatin/vincristine, quinolone antibiotics such as ciprofloxacin).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: alcohol, certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
It is very important for women to use 2 forms of effective birth control while taking this medication. Some drugs may cause hormonal birth control (such as pills, patch, ring) to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control while using the new drug and for 1 month after stopping the drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: prolonged sleep.
Do not share this medication with others. Do not donate blood, organs, eggs, or sperm while taking thalidomide.
Laboratory and/or medical tests (e.g., pregnancy tests, white blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Keep capsules in the original blister pack until ready to use. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2013. Copyright(c) 2013 First Databank, Inc.
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