Thalidomide

(tha LI doe mide)

Trade name:  Thalomid^®

Chemocare.com uses generic names in all descriptions of drugs. Thalomid is the trade name for thalidomide. In some cases, health care professionals may use the trade name thalomid when referring to the generic drug name thalidomide.

Drug type: Thalidomide is classified as an "immunomodulatory agent," and an "antiangiogenic agent." (For more detail, see "How this drug works" section below).

What Thalidomide Is Used For:

• This medication has been approved by the FDA, for treatment of skin lesions associated with leprosy.
• It has been under investigation for use in various cancer conditions such as: multiple myeloma, renal cell carcinoma, glioblastoma multiforme and Waldenströms macroglobulinemia. As well as treatment of graft vs. host disease (GVHD) after bone marrow transplant.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Thalidomide Is Given:

• As a capsule by mouth. Each capsule is 50 mg. Capsules should be stored in a cool, dry place and protected from light.
• It is usually taken at night, about an hour before you go to bed, to decrease sleepiness during the daytime.
• In order to receive this drug, there are strict guidelines that you must follow. You will be required to participate in a special program called the "System for Thalidomide Education and Prescribing Safety" (STEPS). You will be asked to fill out a questionnaire before you receive the medication, and every month, while you are taking the drug. Only certain pharmacists and doctors may prescribe or dispense this medication.

The amount of thalidomide you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dosage and schedule.

Side Effects:

Important things to remember about the side effects of thalidomide:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.

There is no relationship between the presence or severity of side effects and the effectiveness of the medication. The following side effects are common (occurring in greater than 30%) for patients taking thalidomide:

• Severe life-threatening human birth defects if taken during pregnancy. (see precautions).
• Sedative effects: fatigue, sleepiness, weakness, confusion, mood changes. You may develop tolerance to the sedative effects of thalidomide after several weeks of therapy.
• Skin rashes; itching, redness, usually occurring over the trunk, back, arms and legs. It is important that all new rashes be reported to your health care professional immediately. If rash occurs thalidomide should be stopped and only restarted after evaluated by health care professional. Although rare, thalidomide may cause a severe skin reaction, called "Stevens-Johnson's syndrome."
• Peripheral neuropathy: in the form of numbness, tingling and pain in the feet or hands. This side effect does not appear to be related to dose or length of time on thalidomide. If symptoms develop, evaluation takes place as to whether drug should be stopped. Symptoms often improve after drug is stopped, but may not resolve completely.
• Constipation

These side effects are less common side effects (occurring in about 10-29%) of patients receiving thalidomide:

• Low white blood cell count. (This can put you at increased risk for infection).
• Dizziness when changing position (from sitting to standing). May be accompanied by slow heart rate, weakness, feeling faint (see blood pressure changes - orthostatic hypotension).
• Swelling of the feet or ankles.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)
• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Extreme fatigue (unable to carry on self-care activities)
• Constipation unrelieved by laxative use
• New skin rashes
• Numbness or tingling of your hands or feet
• Swelling of the feet or ankles. Sudden weight gain
• Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting thalidomide treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• Do not take other medications that may cause drowsiness without first consulting your health care provider. Also avoid alcohol.
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking thalidomide. Severe, life-threatening birth defects may result with even one 50 mg dose. Two methods of contraception, such as latex condoms and spermicides, are required.
• For women of childbearing potential. You must use contraception 4 weeks before you can begin thalidomide. The manufacturer requires you to take a pregnancy test every month before you start a new prescription of thalidomide. This is to ensure that you or your significant other is not pregnant. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Pregnancy category X (Thalidomide may cause fetal harm when given to a pregnant woman. This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking thalidomide, the medication must be stopped immediately and the woman given appropriate counseling).
• Do not breast feed while taking this medication.

Self-Care Tips:

• Take this medication in the evening before bedtime. This may help to minimize daytime drowsiness.
• You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
• Keep your bowels moving. Your health care provider may prescribe a stool softener to help prevent constipation that may be caused by this medicine.
• Drink 2 to 3 quarts of fluid every 24 hours, unless you were told to restrict your fluid intake, and maintain good nutrition. This will decrease your chances of being constipated, and prevent dehydration.
• You may be at risk of infection report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Do not donate blood while you are taking this medication.
• Don't share your pills with anyone!
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking thalidomide, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor. For females of child-bearing potential (intact uterus, menstrual period within 24 months) a negative pregnancy test may be required monthly before the next month's prescription for thalidomide is given.

How Thalidomide Works:

Thalidomide's exact mechanism of action on cancer cells is not clear. It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production. In normal tissue, new blood vessels are formed during tissue growth and repair (i.e. a healing wound), and during the development of baby during pregnancy. Blood vessels carry oxygen and nutrients to tissue that are necessary for growth and survival. In cancer, tumors need blood vessels in order to grow and spread. Through a complex process, endothelial cells (which line the blood vessels) are able to divide and grow and create new blood vessels. This process is called angiogenesis and it occurs in both healthy tissue and in cancerous tissue.

Additionally, thalidomide is known to have various effects on the immune system (immunomodulatory agent), which may contribute to its therapeutic effect. Thalidomide may also alter the production and activity of cytokines (growth factors) involved in the growth and survival of certain cancer cells. There may be an effect on the genes that direct the cell's growth and activity particularly those associated with cytokines (growth factors), apoptosis (cell death), and metabolism.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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