THALIDOMIDE

(tha LID oh mide) Brand: Thalomid

What is the most significant information I must know about thalidomide?

• Thalidomide can reason severe, life-threatening birth defects or death of a child if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one doze of thalidomide can reason major birth defects of the baby's arms and legs, bones, ears, eyes, person, and heart. Never use thalidomide if you are pregnant.

• For Women: You will be required to use two dependable forms of birth control beginning 4 weeks till you start taking thalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row should agree in writing to use birth control till, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking this medicine. You should also have a negative pregnancy test within 24 hours till you start thalidomide treatment. While you are taking thalidomide, you will need to have a pregnancy test weekly during the first month of treatment, and then each 4 weeks thereafter.

• Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

• For Men: You should not reason a woman to become pregnant while you are taking thalidomide because the medication may affect your sperm and reason birth defects in the child. You should agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.

• Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

What is thalidomide?

• Thalidomide affects the immune system. It promotes immune responses to help slow tumor growth.

• Thalidomide is used to treat and prevent the debilitating and disfiguring skin sores caused by erythema nodosum leprosum (ENL), an inflammatory complication of leprosy. It is also used together with other medication called dexamethasone to treat multiple myeloma (bone marrow cancer).

• Thalidomide may also be used for purposes another than those listed in this medicine guide.

What must I discuss with my healthcare provider till taking thalidomide?

• If you have any of these conditions, you may not be able to take thalidomide, or you may need a dosage adjustment or particular trials during treatment:

· liver or kidney disease;

· heart malady, history of stroke or blood clots;

· HIV or AIDS;

· epilepsy or seizures;

· a weak immune system; or

· nerve problems, such as numbness or tingling in your hands or feet.

• It is not known if thalidomide passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

• The birth control method you use should be proven highly effective: hormonal birth control (pills, implants, or injections), an intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth control you use should be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

• Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

• Thalidomide is accessible only under a particular program called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.). You should be registered in the program and sign documents stating that you understand the dangers of this medicine and that you agree to use birth control as required by the program. For patients between 12 and 18 years, a parent or legal guardian should read and sign all written requirements for the S.T.E.P.S. program. Do not give this medication to a baby younger than 12 years old.

How must I take thalidomide?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results.

• Swallow the capsule intact, without breaking it open.

• Thalidomide is generally taken at bedtime. Take the medication on an empty stomach, at least 1 hour after eating a meal.

• While you are using thalidomide, you will be required to be listed on a patient registry and participate in casual phone surveys. You will be limited to a 28-day supply of thalidomide every time your prescription is refilled. You may continue getting refills only if you participate fully in the S.T.E.P.S. program and commit to all agreements.

• Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

• You should not donate blood or sperm while you are using thalidomide. Avoid exposing other face to your blood or semen through occasional or sexual contact.

• Never give thalidomide to other face, even if he or she has the same mess for which you are being treated.

• Store thalidomide at room temperature away from moisture and heat. Hold every capsule in its blister pack before you are ready to take it.

• Do not let other face to handle your medication without wearing disposable gloves. Caregivers must avoid handling broken capsules or inhaling the powder from a damaged capsule.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking thalidomide?

• Thalidomide may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

• Drinking alcohol can magnify determined side effects of thalidomide.

• This medication can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a doze, avoid allowing your body fluids to come into contact with your hands or another surfaces. Patients and caregivers must wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands till and after removing gloves. Wash soiled clothing and linens apart from another laundry.

• Body fluids must not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

What are the possible side effects of thalidomide?

• Stop using this medication and get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have any of these serious side effects:

· chest pain, sudden shortness of breath, coughing up blood;

· pain or swelling in your hand, thigh, or calf;

· fever, chills, body aches, flu symptoms, light bruising or bleeding;

· slow heartbeats, shallow breathing, feeling like you might pass out;

· a red, blistering, peeling skin rash;

· a red, raised skin rash (especially if you also have fever, quick heart course, and dizziness or fainting);

· numbness, burning, pain, or tingly feeling; or

· seizure (convulsions).

• Smaller serious side effects may include:

· feeling drowsy or sleepy;

· anxiety, confusion, tremors or shaking;

· bone pain, muscle weakness;

· sleep problems (insomnia); or

· nausea, constipation, loss of appetite.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect thalidomide?

• Cool or allergy medication, sedatives, narcotic pain medication, sleeping pills, muscle relaxers, and medication for seizures, depression or anxiety can add to sleepiness caused by thalidomide. Speak your doctor if you regularly use any of these medicines.

• If you use hormonal birth control (pills, implants, injections) to prevent pregnancy: There are determined drugs that can create hormonal birth control smaller effective in your body. This list may not include all drugs that can affect hormonal birth control.

· HIV medicines such as tipranavir, indinavir, saquinavir, lopinavir/ritonavir, fosamprenavir, ritonavir, atazanavir, or nelfinavir;

· griseofulvin;

· rifampin;

· rifabutin;

· phenytoin; or

· carbamazepine.

• If you rely on hormonal birth control during your treatment with thalidomide, speak your doctor about all another medicines you use. You may need to replace your hormonal birth control method with other effective form of contraception. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

• This list is not complete and another drugs may interact with thalidomide. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist has more information about thalidomide written for health professionals that you may read.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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