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Thalidomide

(thah-lid-oh-mide)

Trade/other name(s): Thalomid

Why would this drug be used?

This drug is used to treat multiple myeloma, a type of bone marrow cancer. It is also being studied for use against kidney cancer and some other cancers.

How does this drug work?

The exact way this drug works against cancer cells is not clear. Thalidomide is known to be an immunomodulating agent, which means that it affects some of the functions of the immune system. It also appears to work in part by slowing or stopping the growth of new blood vessels (angiogenesis), which tumors need to grow and survive. It may also have direct effects on cancer cells themselves.

Before taking this medicine

Tell your doctor…

  • If you are allergic to any medicines, dyes, additives, or foods.
  • If you take any blood pressure medicines or have a history of fainting. This drug may lower your blood pressure, which could be dangerous if it is already affected by other medicines.
  • If you have ever had major blood clots or bleeding problems. This drug may increase your risk of blood clots.
  • If you have ever had seizures. Rarely, people have reported seizures while on thalidomide.
  • If you have any other medical conditions such as kidney disease, liver disease (including hepatitis), heart disease, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. Thalidomide is known to cause severe birth defects and fetal deaths. Women of child-bearing potential must use 2 types of reliable birth control at the same time during treatment with thalidomide, as well as for 4 weeks before starting and 4 weeks after stopping the drug. Women of child-bearing potential will need to have a pregnancy test within 24 hours before starting the drug, weekly during the first month of treatment, and then every 2 to 4 weeks throughout treatment. Notify the doctor if birth control methods are stopped, menstrual periods are missed or become irregular, or if for any reason pregnancy is suspected. Men who have sex with women of child-bearing potential must use condoms during treatment and for the first 4 weeks after treatment is stopped. Men taking the drug must use condoms to protect partners from pregnancy and drug exposure in semen.
  • If you are breast-feeding. This drug may pass into breast milk and affect the baby. Women should not breast-feed during treatment with this drug.
  • If you think you might want to have children in the future. It is not known if this drug may affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Thalidomide can cause drowsiness, which may be made worse if you are taking other medicines that may cause drowsiness or consuming alcohol.

Thalidomide can cause numbness, tingling, or burning sensations in the hands or feet (peripheral neuropathy). Some other drugs may increase the risk for this side effect, including amiodarone, isoniazid, nitrofurantoin, antiviral drugs, or "statin" cholesterol-lowering drugs (simvastatin, atorvastatin, etc.).

Certain chemotherapy drugs, such as dexamethasone, increase the risk of blood clots even further if taken with thalidomide. Your doctor may give you blood thinners or tell you to take aspirin while you are on these drugs to help prevent clotting.

If you are taking birth control pills while on thalidomide, they may not work if you take HIV treatment drugs, certain antibiotics, anti-seizure drugs, or St. John's wort. If you must take one of these drugs, you will need 2 other forms of contraception while taking thalidomide. Talk with your pharmacist or doctor about this.

No other serious interactions with other drugs are known at this time. But this does not necessarily mean that none exist. Check with your doctor, nurse, or pharmacist about any other medicines, herbs, and supplements you are taking.

Interactions with foods

No serious interactions with food (other than alcohol) are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Thalidomide is a capsule taken once a day with water, preferably at bedtime at least an hour after the evening meal. Do not break, chew, or open the capsules. The dose will depend on a number of factors, including the condition being treated. The dose may need to be interrupted or lowered if you have side effects.

Note that, because of restrictions on the use of thalidomide due to the risk of serious birth defects, only certain doctors and pharmacists offer it. A program of special requirements is in place, which may include pregnancy tests, informed consent, and written agreements before you start this drug.

Store the medicine in its sealed blister packs, away from heat and moisture and away from children and pets. Do not share your medicines with anyone else.

Precautions

Thalidomide may make you sleepy. Do not drive, operate heavy machinery, or perform other tasks requiring mental alertness until you find out how this medicine affects you.

This drug may increase your risk of major blood clots in the veins of the legs or lungs. Tell your doctor right away if you notice chest pain, shortness of breath, or swelling, pain, redness, or warmth in an arm or leg.

This drug can cause a quick drop in blood pressure when you go from lying down to sitting up, or from sitting to standing up (postural hypotension), which can make you feel dizzy or even faint. Changing position slowly and making sure you have a secure surface to hold on to can reduce the risk of falls or injuries. Your doctor will probably advise you to drink plenty of liquids during your treatment to help prevent this. Let the doctor know if you keep having this problem.

This drug may cause damage to certain nerves in the body, which can lead to a condition called peripheral neuropathy. This can cause numbness, weakness, pain, or sensations of burning or tingling, usually in the hands or feet. These symptoms can sometimes progress to include sensitivity to cold or trouble walking or holding something in your hands. Let your doctor know right away if you notice any of these symptoms. Thalidomide may need to be stopped. If the symptoms go away completely, you may be able to take it again later.

Your doctor will likely test your blood each week for the first 2 months of your treatment and frequently thereafter, looking for possible effects of the drug on blood counts or on blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5º or higher), chills, pain when passing urine, a new cough, or bringing up sputum.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor's OK. This drug may affect your immune system, which could make vaccinations ineffective, or could even lead to serious infections. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

While taking this medicine, and for a few days afterward, there is a slight chance of a serious skin reaction. Symptoms often start as a skin rash with redness or blistering in the mouth, nose, or eyes, along with fever and body aches. If this happens, stop the drug and call your doctor right away.

Do not donate blood or sperm while taking this drug and for 4 weeks after stopping it, as this drug may enter these body fluids.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • feeling dizzy or lightheaded, especially when first standing or sitting up*
  • drowsiness*
  • low white blood cell counts with increased risk for infection*
  • rash
  • tiredness

Less common

  • numbness or tingling in hands or feet*
  • headache
  • confusion
  • diarrhea
  • constipation
  • fever
  • weakness
  • cough
  • dry skin
  • weight gain

Rare

  • blood clot in the deep veins of the leg or in the lungs*
  • slowed heart rate
  • allergic reactions (rash or hives, fever, rapid heart rate, low blood pressure)
  • seizures

*See the "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2006.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 10/27/2009
Last Revised: 10/27/2009