Overview: Thalomid is commonly used to treat cancer and skin conditions. Common side effects include tiredness, low calcium levels, and constipation. Call your health care provider right away if you have fever, infection, chest pain, or symptoms of a stroke. Thalomid is a capsule you will take by mouth.
Uses
What is Thalomid used for?
Thalomid (thalidomide) is commonly used to treat certain types of multiple myeloma (MM) and erythema nodosum leprosum (ENL).
Thalomid may also be used for other conditions as determined by your health care provider.
How does Thalomid work (mechanism of action)?
In multiple myeloma, Thalomid works by turning on your immune system to recognize and kill cancer cells. It also stops cancer cells from growing and multiplying. When used for ENL, it works by reducing inflammation and helps treat and prevent ENL.
How is Thalomid supplied (dosage forms)?
Brands and other names
- Thalomid
Dosage forms and strengths
- 50 mg oral capsules
- 100 mg oral capsules
- 150 mg oral capsules
- 200 mg oral capsules
How should I store Thalomid?
Thalomid should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place and keep it away from light. Keep Thalomid in the blister pack it comes in until you are ready to take your dose each day.
Side Effects
What are the most common side effects of Thalomid?
The most common side effects of Thalomid are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Tiredness, weakness, dizziness
- Low calcium levels
- Fluid retention
- Constipation, nausea, loss of appetite, weight loss or gain
- Nerve problems (see below)
- Shortness of breath
- Muscle weakness
- Low blood cell levels, including low neutrophil levels (neutropenia) and low platelet levels (thrombocytopenia) (see below)
- Rash, dry skin
- Confusion
- Anxiety
- Tremor
- Fever
- Blood clots (see below)
- Headache
There may be other side effects of Thalomid that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Thalomid?
While less common, the most serious side effects of Thalomid are described below, along with what to do if they happen.
Severe Allergic Reactions. Thalomid may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Shortness of breath, trouble swallowing, or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Dark-colored urine
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Blood Clots. Thalomid may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop taking Thalomid and get emergency help if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Low Neutrophil Levels (Neutropenia). Thalomid may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Make sure to keep all appointments to have your blood cell counts checked and tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.
- Fever, chills, or sweats
- Tiredness
- Sore throat, cough, or shortness of breath
- Mouth or throat sores
- Swollen lymph nodes
Severely Low Platelet Levels. Thalomid can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Make sure to keep all appointments to have your blood cell counts checked and tell your health care provider if you have any of the following symptoms of low platelet levels.
- Easy bruising or bleeding
- Bleeding that does not stop
- Nosebleeds
Drowsiness. Thalomid can affect your alertness or coordination by causing drowsiness. Do not drive or do other activities that require alertness or coordination until you know how Thalomid affects you. It is also important to avoid taking other medicines that can also cause drowsiness.
Nerve Problems. Nerves are the fibers that carry sensations from your body to the brain. Damage to these nerves, called peripheral neuropathy, can happen in people who are taking Thalomid. Stop taking Thalomid and call your health care provider if you develop pain, burning, tingling, numbness, or weakness in your arms, hands, legs, or feet.
Low Blood Pressure Upon Standing (Orthostatic Hypotension). Thalomid may cause a sudden drop in blood pressure when standing up from a seated or lying position. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your health care provider right away if you have any of the following symptoms of orthostatic hypotension.
- Dizziness, feeling lightheaded, or fainting upon standing
- Blurred vision
- Confusion
- Feeling weak
Heart Rate Changes. Thalomid can make your heart beat slower than normal (bradycardia). Call your health care provider right away if you have any of the following symptoms of bradycardia.
- Feeling lightheaded, dizziness, or fainting
- Confusion
- Feeling weak or easily tired
- Slow heartbeat or a feeling of skipped heartbeats
- Chest pain
- Shortness of breath
Severe Skin Reactions. Thalomid can cause severe skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop Thalomid and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.
- Painful red or purple skin that looks burned and peels off
- Flat red rash or blisters on your skin, mouth, nose, and genitals
- Red, painful, watery eyes
- Flu-like symptoms, including fever, chills, and muscle aches
Tumor Lysis Syndrome. Thalomid can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while taking Thalomid and to keep all appointments for blood tests so your health care provider can see how your body is responding to Thalomid. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking Thalomid.
- Nausea and vomiting
- Weakness
- Swelling or fluid retention
- Shortness of breath
- Muscle cramps
- Seizures
Warnings & Precautions
Who should not use Thalomid?
Allergies to Ingredients. People who are allergic to any of the following should not take Thalomid.
- Thalidomide
- Thalomid
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Thalomid.
Pregnancy. Do not take Thalomid if you are pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details.
What should I know about Thalomid before using it?
Do not take Thalomid unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share Thalomid with other people, even if they have the same condition as you. It may harm them.
Keep Thalomid out of the reach of children.
Thalomid is only available through a special program, from certain pharmacies, and to certain people. It is important that you keep all of your appointments, including labs or other testing, while taking Thalomid. If you have any questions about this program, you can go to www.thalomidrems.com or call 888-423-5436.
Thalomid should be taken with water at least one hour after a meal in the evening. It is recommended to take Thalomid at bedtime.
Do not break, chew, crush, or open the Thalomid capsules. If powder from the capsule accidentally comes into contact with your skin, wash the area right away with soap and water. If powder from the capsule comes into contact with your eyes, nose, or mouth, rinse the area with water right away.
You should not donate blood while you are taking Thalomid, even if you are taking a break from the medicine. You should also not donate blood for four weeks after your last dose.
What should I tell my health care provider before using Thalomid?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Thalomid is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- History of seizures
- Drink alcohol
- Plans to have surgery
- Previous or current blood clot
- Have HIV
- Prior or current smoker
Other Medicines and Supplements. Thalomid may interact with other medicines and supplements. Before taking Thalomid, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Thalomid can harm a fetus. If you are able to get pregnant, your health care provider will make sure you are not pregnant before you start taking the medicine. The Thalomid REMS program requires two negative pregnancy tests at certain times before starting to take Thalomid. While taking Thalomid, you will need to use two forms of effective birth control for four weeks before starting Thalomid, during your treatment (including if you take any breaks from treatment), and for at least four weeks after your last dose. You will also need to take regular pregnancy tests while taking Thalomid. Tell your health care provider if you are pregnant or plan to become pregnant. If you think there is a chance you could be pregnant due to failed birth control while taking Thalomid, call your health care provider right away.
If you are able to get a partner pregnant, you will need to use effective birth control (condoms) while taking Thalomid and for four weeks after your last dose. You will need to use condoms even if you have had a vasectomy. Do not donate sperm while taking Thalomid and for four weeks after your last dose. If you get a partner pregnant while taking Thalomid, call your health care provider right away.
Breastfeeding. It is not known if Thalomid passes into breast milk. You should not take Thalomid while breastfeeding. Tell your health care provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Thalomid?
For more information about Thalomid, you can visit the drugmaker’s website at www.thalomidrems.com or call them at 888-423-5436.
Interactions
Does Thalomid interact with foods or drinks?
Thalomid interacts with food. It should be taken at least one hour after your evening meal, with bedtime being the recommended time to take the dose.
It is unknown if drinking alcohol will affect Thalomid, but heavy drinking can slow your immune response and make it harder for your body to fight infections and cancer.
Does Thalomid interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Thalomid.
- Pembrolizumab, an immunotherapy medicine used to treat certain cancers
- A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD)
- Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety
- A calcium channel blocker, such as diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
- A beta blocker, such as atenolol, bisoprolol, metoprolol, or propranolol, which is a medicine used for high blood pressure or other conditions
- Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
- An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
- Lithium, which is a medicine for certain mental health conditions
- A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
- Neuromuscular blockers, such as succinylcholine, which are medicines used to relax muscles during surgery
- Erythropoietic agents, such as darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit), which are medicines used to treat anemia (low red blood cells)
- Warfarin, which is a blood thinner
- Medicines that cause peripheral neuropathy, such as cisplatin, docetaxel, paclitaxel, or vincristine, which are chemotherapies used to treat cancer
- A protease inhibitor, such as atazanavir (Reyataz), nelfinavir (Viracept), or ritonavir (Norvir), which is a medicine commonly used to treat HIV
- Any medicine for seizures, such as carbamazepine, phenobarbital, or phenytoin
- Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
This may not be a complete list of medicines that can interact with Thalomid. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Thalomid?
If you or someone else has used too much Thalomid, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Thalomid?
If you miss a dose, take it as soon as you remember as long as it has been less than 12 hours from the usual time you take the dose. If it is more than 12 hours, skip the missed dose and only take the next dose. Do not take double or extra doses.
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