Trade/other name(s): Thalomid
Why would this drug be used?
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 anything, including 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 plan to have surgery or any medical procedure.
- If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy for yourself or your partner. Thalidomide is known to cause severe birth defects and fetal deaths. See “Precautions” section.
- 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. Alcohol, opioids (narcotic type pain medicines), antihistamines (allergy medicines), antipsychotics (drugs for mental health conditions), anti-anxiety agents, or other such drugs should be avoided.
Thalidomide can cause nerve damage (peripheral neuropathy), leading to numbness, tingling, or burning sensations in the hands or feet. Some other drugs may increase the risk for this side effect, including amiodarone, isoniazid, nitrofurantoin, phenytoin, metronidazole, disulfiram, antiviral drugs, or “statin” cholesterol-lowering drugs (simvastatin, atorvastatin, etc.). Cancer treatment drugs that can worsen the problem include bortezomib, cisplatin, docetaxel, paclitaxel, and vincristine.
Drugs that may slow down conduction in the heart may cause an even slower heartbeat while a person takes thalidomide. They can increase your risk of very slow heartbeat and fainting:
- Calcium channel blockers such as amlodipine (Norvasc), nifedipine, felodipine (Plendil), nimodipine (Nimotop), nicardipine (Cardene), lacidipine (Aponil, Caldine), lercanidipine (Zanidip),
- Beta blockers, such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), esmolol (Brevibloc), metoprolol (Lopressor, Lopressor LA, Toprol XL), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and timolol (Blocadren)
- Certain blood pressure medicines (alpha/beta blockers) such as carvedilol (Coreg) and labetalol (Trandate)
- Digoxin (Lanoxin)
- Stomach acid reducers known as H2 blockers, like cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), or nizatidine (Axid)
- Lithium (Eskalith, Lithobid)
- Tricyclic antidepressants such as amitriptyline (Elavil), nortriptyline (Pamelor), imipramine (Tofranil), desipramine (Norpramin), doxepin (Sinequan), and others
- Neuromuscular blockers or paralyzing agents (such as succinylcholine)
Thalidomide can increase the risk of blood clots (see “Precautions”). The risk is much higher if thalidomide is taken with certain drugs, such as dexamethasone, and other drugs that raise the risk of blood clots, such as:
- Estrogen-containing drugs, such as conjugated estrogens (Premarin, Enjuvia), estradiol (Estrace), esterified estrogens (Amnestogen, Estratab, Evex, Femogen, Menest), estropipate (Ogen, Ortho-est)
- Drugs that stimulate the body to make red blood cells, such as epoetin alfa (Procrit, Epogen), darbepoetin alfa (Aranesp)
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 to prevent pregnancy 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
Drinking alcohol can make sleepiness worse and raise the risk of peripheral neuropathy (see above.)
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.
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 abnormal blood clots, such as blood clots in the veins of the legs (deep venous thrombosis) or arteries of the lungs (pulmonary embolus). Your doctor may give you blood thinners or tell you to take aspirin to help lower this risk. Tell your doctor right away if you notice chest pain, shortness of breath, or swelling, pain, redness, or warmth in an arm or leg.
Heart disease, heart attacks, and strokes also occur at a higher rate in people taking this drug. Get emergency help for any symptoms of a heart attack or stroke, such as pain or pressure in the chest, shortness of breath; or numbness, weakness, or trouble moving one side of the body; confusion; or trouble speaking.
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 can cause a slow heart rate, which can lead to feeling lightheaded or even passing out. Let your doctor know if you feel faint, dizzy, or lightheaded while on this drug.
This drug can cause the rapid killing of large numbers of tumor cells, which then break open and release their contents into the bloodstream. This, called tumor lysis syndrome, can lead to kidney failure and might also affect the heart and nervous system. It’s most common at the beginning of treatment. If your doctor thinks you are at risk for it, you will get medicines and be encouraged to drink lots of fluids during the first days of treatment to help the body get rid of these substances. Tell your doctor or nurse if you have nausea, vomiting, diarrhea, or tiredness or if you feel weak or faint, have trouble breathing, or notice swelling in the first few days of taking it.
This drug may cause nerve damage, 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.
Low levels of calcium in the blood can cause muscle stiffness, twitching, and cramps; numb fingertips and lips; tremors; and other symptoms. Your doctor may check your blood calcium levels during treatment.
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.
This drug is known to cause severe birth defects or even death of the embryo or fetus. Women of child-bearing potential must be checked for pregnancy before and during treatment with this drug, and must use 2 forms of birth control while taking thalidomide, as well as for 4 weeks before starting and 4 weeks after stopping the drug. Tell your doctor if birth control methods are stopped, menstrual periods are missed or become irregular, or if for any reason pregnancy is suspected.
If you have HIV infection, your doctor may check your viral load more often during treatment with this drug. Thalidomide may raise viral load in some people.
Thalidomide is present in the semen of men taking the drug. Men taking thalidomide must use condoms during treatment and for 4 weeks after stopping the drug. This protects partners from pregnancy and prevents partners from being exposed to the drug in their semen.
It might be possible to become dependent on thalidomide; however, as with other tranquilizers/hypnotics, thalidomide has been reported to result in habituation to its soporific effects.
If powder from thalidomide touches the skin, wash the skin immediately and thoroughly with soap and water. If it touches the mucous membranes, flush thoroughly with water.
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.
- Feeling dizzy or lightheaded, especially when first standing or sitting up*
- Low white blood cell counts with increased risk for infection*
- Low levels of calcium in the blood, which may cause symptoms*
- Nerve damage, causing numbness or tingling in hands or feet (sensory neuropathy) or weakness and coordination problems, stumbling and dropping things (motor neuropathy)*
- Loss of appetite
- Weight change (gain or loss)
- Swelling in the hands or feet
- Blood clot in the deep veins of the leg or in the lungs*
- Shortness of breath
- Rash or dry skin
- Muscle or joint pain
- Muscle twitching or cramping*
- Heart attack*
- Severe skin reactions*
- Slowed heart rate*
- Allergic reactions (rash or hives, fever, fast heartbeat, faintness, dizziness, low blood pressure)
- Death due to skin reaction, stroke, heart attack, or blood clot in the lungs
*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.
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 Revised: 08/22/2014