Thalomid
Thalomid (thalidomide) is an immunomodulatory medication. It’s used to treat a certain type of blood cancer called multiple myeloma (MM). It’s also used to treat a skin condition called erythema nodosum leprosum (ENL) that can develop in people with leprosy. You take this medication by mouth, typically once daily. Thalomid (thalidomide) causes severe birth defects and death to unborn babies, so there’s a special risk management program that you must follow in order to take this medication. Some of the more common side effects of this medication include tiredness, muscle or joint pain, and swelling.
What is Thalomid (thalidomide)?
What is Thalomid (thalidomide) used for?
- Newly diagnosed multiple myeloma, given together with dexamethasone
- Prevention and treatment of a skin reaction in leprosy (erythema nodosum leprosum)
How Thalomid (thalidomide) works
We don’t completely understand how Thalomid (thalidomide) works to treat multiple myeloma. But we do know it blocks several pathways that otherwise help cancer cells grow. When Thalomid (thalidomide) blocks pathways like these, multiple myeloma cells can’t grow and spread as well. It also activates the immune system to attack and kill cancer cells.
In addition, Thalomid (thalidomide) blocks the activity of tumor necrosis factor-alpha (TNF-alpha), which are inflammatory signals made by the body. TNF-alpha causes inflammation, which worsens skin conditions like erythema nodosum leprosum (ENL) in leprosy. When Thalomid (thalidomide) blocks TNF-alpha, the skin lesions get better.
Drug facts
Side effects of Thalomid (thalidomide)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Tiredness (up to 79%)
- Lower calcium levels in blood (72%)
- Pain (63%)
- Swelling (up to 56%)
- Constipation (up to 55%)
- Numbness and tingling (54%)
- Trouble breathing (42%)
- Muscle weakness (up to 40%)
- Lower white blood cell counts (35%)
- Rash (30%)
- Confusion (28%)
- Lower appetite (28%)
- Nausea (up to 28%)
- Feeling nervous or anxious (up to 26%)
- Tremor/shaking (26%)
Less Common Side Effects
- Fever
- Weight loss or gain
- Dizziness
- Blood clot
- Dry skin
- Dry mouth
- Depression
Please note: The side effects of Thalomid (thalidomide) might differ depending on what condition you’re taking it for.
Thalomid (thalidomide) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clots in the lung, arm, or leg: trouble breathing, chest pain, swelling or pain in the arm or leg
- Heart attack: Chest pain that spreads to the stomach or back, trouble breathing, nausea, vomiting
- Stroke: headache, confusion, numbness or weakness on one side of the body, vision problems, trouble speaking
- Serious skin reactions: painful blisters, skin wounds, peeling skin, fever, sore throat, body aches
- Low white blood cell counts: fever, signs of infection such as cough, body aches, or chills
- Serious bleeds: bleeding that’s difficult to stop, bruises that don’t go away, nausea, vomiting, pain, pale and clammy skin
More on Thalomid (thalidomide) side effects
The following Thalomid (thalidomide) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
black, tarry stools
chills
confusion
dizziness or lightheadedness
fainting
fast heartbeat
irregular heartbeat
irritability
loss of taste
lower back or side pain
mood or mental changes
muscle cramps in the hands, arms, feet, legs, or face
muscle weakness
nervousness
numbness and tingling around the mouth, fingertips, or feet
pain in the chest, groin, or legs, especially the calves
pain, redness, or swelling in the arm or leg
painful or difficult urination
pale skin
peeling and loosening of the skin
restlessness
seizures
severe, sudden headache
skin rash
shakiness in the legs, arms, hands, or feet
slurred speech
sores, ulcers, or white spots in the mouth or on the lips
stomach cramps
sudden, unexplained shortness of breath
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
swollen glands
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
tingling, burning, numbness, or pain in the hands, arms, feet, or legs
trembling or shaking of hands or feet
trouble sleeping
troubled breathing
unusual bleeding or bruising
unusual tiredness or weakness
vision changes
Rare
Blood in the urine
decreased urination
Incidence not known
Bleeding gums
blistering of the skin
blood in the stools
difficulty with speaking
inability to move the arms, legs, or facial muscles
inability to speak
itching skin
muscle jerking of the arms and legs
pinpoint red spots on the skin
red skin lesions, often with a purple center
red, irritated eyes
slow speech
sudden loss of consciousness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Headache
increased appetite
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Thalomid (thalidomide)
Pros
- Taken by mouth, so good for people who don’t like needles
- Taken only once a day, so more convenient
- Recommended treatment for people with erythema nodosum leprosum
Cons
- Can cause severe birth defects
- Only accessible through a specific access program, so less convenient
- Leads to a higher risk of blood clots
Pharmacist tips for Thalomid (thalidomide)
- You should take your daily dose of Thalomid (thalidomide) in the evening, ideally at bedtime. Take it at least 1 hour after your evening meal.
- Some people taking Thalomid (thalidomide) experience constipation. Make sure you drink plenty of fluids while taking Thalomid (thalidomide). There are several over-the-counter medications your provider might recommend, such as bisacodyl (Dulcolax). If you have constipation with serious stomach pain or a hard belly, contact seek medical help right away.
- Thalomid (thalidomide) can cause dizziness, feeling tired, and difficulty staying awake. If you feel dizzy or tired, don’t drive or operate any type of machine.
- Females who are taking Thalomid (thalidomide) shouldn’t breastfeed. Thalomid (thalidomide) hasn’t been studied in human milk, but because of the possible risks to a baby, it’s best to avoid nursing if you’re taking Thalomid (thalidomide).
- Ask your provider about the best way to handle and throw away Thalomid (thalidomide) safely. Anticancer medications can be harmful to people who handle or come in contact with them. You should store the medication up and away, so children and pets won’t be able to reach it.
- If you have leftover medication, ask your provider how to dispose of it. They might allow you or a family member to bring it to their office or clinic for proper disposal.
Additional precautions to minimize thalidomide exposure to unborn babies:
- Females who can become pregnant must have a negative pregnancy test before starting Thalomid (thalidomide). In addition, you must take monthly pregnancy tests during treatment, and use 2 forms of effective birth control, such as hormonal birth control or intrauterine device (IUD), starting a month before treatment and continuing a month after your last dose.
- Males taking Thalomid (thalidomide), including people who’ve had a vasectomy, should always use a condom during any sexual contact with a female who is or can become pregnant. You must continue to do so for up to a month after your last dose. Also, don’t donate sperm during Thalomid (thalidomide) treatment and up to a month after your last dose.
- Don’t donate blood or blood products while taking Thalomid (thalidomide) or for 4 weeks after the last dose. A pregnant person might receive the blood donation and the [EDITOR|DRUG_DISPLAY_NAME]] in the blood product can cause serious birth defects to the unborn baby.
- Some medications interact with hormonal birth control pills, which can make the birth control less effective. Examples include certain antibiotics (e.g., penicillins) and some herbal supplements (e.g., St. John’s Wort). Make sure you talk to your provider or pharmacist before starting any new medications. Because preventing pregnancy is required while taking Thalomid (thalidomide), if you need to take another medication that interacts with birth control pills, you might need to consider non-hormonal birth control options.
Common questions about Thalomid (thalidomide)
No, Thalomid (thalidomide) isn’t considered a chemotherapy medication. Instead of attacking cells that are growing quickly, which is how chemotherapy works, Thalomid (thalidomide) works as an immunomodulatory agent. This means it makes changes to the immune system to help fight cancer, such as multiple myeloma. It also lowers inflammation that can cause skin problems in people with leprosy. Because Thalomid (thalidomide) doesn’t work like chemotherapy, it doesn’t typically cause chemotherapy-related side effects, like nausea or hair loss. But, it can cause other side effects such as feeling tired and blood clots.
If you’re taking Thalomid (thalidomide) to treat multiple myeloma, your provider might recommend you to take a blood thinner such as aspirin or enoxaparin (Lovenox) to prevent blood clots. People with multiple myeloma are already at higher risk for developing blood clots. Study shows that taking an immunomodulatory medication, such as Thalomid (thalidomide), can raise the risk of blood clots even higher in this group. It’s not clear if the risk of blood clot is higher in people taking Thalomid (thalidomide) for ENL.
A Risk Evaluation and Mitigation Strategy (REMS) program is a special program created by the FDA for medications that can cause serious side effects. There are strict requirements for everyone involved in prescribing and dispensing Thalomid (thalidomide), as well as for those taking this medication. Thalomid (thalidomide) has a REMS program because it can cause severe birth defects and miscarriage (pregnancy loss) if it’s taken by pregnant females. So this program is to minimize the risk of exposing unborn babies to this medication. The Thalomid (thalidomide) REMS program requires females who can become pregnant to take regular pregnancy tests, and for both females and males to use birth control before, during, and after treatment with Thalomid (thalidomide).
Based on some of Thalomid (thalidomide)’s side effects, taking some medications that also cause those side effects might make them worse. This doesn’t always mean you can’t take them together, but you might need to be more careful, or your provider might need to monitor you more closely. For example, Thalomid (thalidomide) commonly causes tiredness and difficulty staying awake, which might be worse if you take other medications that cause tiredness, such as diphenhydramine (Benadryl) or opioid pain medications. Or, because Thalomid (thalidomide) might cause lower heart rate, taking other medications that also cause that, such as a beta blocker for blood pressure, could make this side effect worse. Your provider or pharmacist will review the medications you take when you start taking Thalomid (thalidomide). Don’t stop or start a new medication while you’re taking Thalomid (thalidomide) without contacting your provider.
Thalomid (thalidomide) can cause peripheral neuropathy, or a feeling of numbness and tingling in the fingers and toes. This side effect is seen more often in people taking Thalomid (thalidomide) for multiple myeloma than it is for people taking it for ENL. It usually doesn’t appear right away, but after a few months of treatment. Your provider will monitor and examine you for this side effect every month for the first 3 months of treatment, and less frequently after that. You should also watch for signs of neuropathy between clinic visits. If you do develop nerve problems, your provider will likely ask you to stop taking Thalomid (thalidomide) to prevent further damage. If you have new or worse numbness that affects your daily activities, such as holding a pen or buttoning a shirt, for example, contact your provider.
Though it’s not common, it’s possible for Thalomid (thalidomide) to cause nausea. It’s usually mild. Your provider might recommend an oral medication to help manage nausea, such as ondansetron (Zofran) or prochlorperazine (Compazine). Contact your provider if you’re experiencing nausea that’s severe or won’t go away.
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Risks and warnings for Thalomid (thalidomide)
Thalomid (thalidomide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Harm to unborn baby and REMS program
- Risk factors: Pregnancy
Thalomid (thalidomide) has a FDA black box warning because there’s a risk it can cause severe birth defects or miscarriage, even after one dose. All people who take or are involved in prescribing and dispensing this medication must register with a special Risk Evaluation and Mitigation Strategies (REMS) Program. The purpose of the REMS program is to minimize the risk of thalidomide exposure to unborn babies. Females who can become pregnant must take regular pregnancy tests during treatment. In addition, they must use 2 forms of effective birth control a month before starting Thalomid (thalidomide), during, and continuing a month after treatment ends. Males must use condoms during sexual activity, even if they’ve had a vasectomy. In addition, males who take Thalomid (thalidomide) shouldn’t donate sperm. All people who can become pregnant, including those not taking Thalomid (thalidomide) , should avoid touching Thalomid (thalidomide) capsules. If you do become pregnant while taking Thalomid (thalidomide), please contact your provider immediately.
Thalomid (thalidomide) has a FDA Risk of blood clot
- Risk factors: Smoking | Multiple myeloma | Taking medications that raises estrogen levels
People with multiple myeloma are at higher risk for blood clots. This risk is highest in people with multiple myeloma who also take an immunomodulatory medication, like Thalomid (thalidomide). These blood clots can include deep vein thrombosis (DVT) or pulmonary embolism (PE), and sometimes lead to heart attacks. Your provider might recommend you take a blood thinner such as aspirin or enoxaparin (Lovenox) to lower your risk of blood clots while you’re taking Thalomid (thalidomide). If you have any signs of a blood clot such as swelling and redness in one arm or one leg, sudden and severe trouble breathing, or chest pain, get medical help right away.
Difficulty staying awake
- Risk factors: Drinking alcohol | Taking other medications that can cause drowsiness Many people taking Thalomid (thalidomide) often feel like they need to sleep (drowsiness) and might have trouble staying awake. The risk is higher if you’re also taking other medications that can make you sleepy. Because of this, it might not be safe to drive or perform certain activities where you need to be awake and alert.
Dizziness and passing out
Thalomid (thalidomide) can cause dizziness and a condition called orthostatic hypotension, which means your blood pressure can drop too low when you sit up or stand up. Sometimes this can cause you to faint or pass out. When you get up from a lying down position, sit up for a few minutes before you try to stand. This can help prevent dizziness and stop your blood pressure from dropping too low.
Numbness in fingers and toes
Some people who take Thalomid (thalidomide) experience peripheral neuropathy, or a feeling of numbness or tingling in their fingers and toes. While it’s possible to happen any time, it typically develops after you take Thalomid (thalidomide) for several months. Sometimes, this problem can become permanent. If you have symptoms of neuropathy, your provider will likely ask you to stop Thalomid (thalidomide) treatment to prevent further damage. Your provider will monitor and examine you for this side effect, but you should also watch for signs of neuropathy between clinic visits. If you have new or worsening numbness that affects your daily activities, such as being unable to hold a pen or button a shirt, for example, contact your provider.
Risk of infection and bleeding (from lower blood cell counts)
People who take Thalomid (thalidomide) sometimes have low blood cell counts, particularly low white blood cells (WBCs) and platelets. Having low WBC counts can raise your risk of getting serious infections. And having low platelet levels can put you at higher risk for bleeding that’s difficult to stop. Your provider will regularly check your blood cell counts while you’re taking Thalomid (thalidomide) to make sure they’re within a safe range. You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. If you have signs of low platelets such as bruising, nose bleeds, or blood in stool or urine, contact your provider right away.
If you have human immunodeficiency virus (HIV), talk with your provider. Past studies suggest that people might develop a higher HIV viral load after starting Thalomid (thalidomide). Your provider might want to measure your viral load more often if you take this medication.
Lower heart rate
Risk factors: Taking other medications that can slow heart rate People who take Thalomid (thalidomide) might experience a slow heart rate, which can cause tiredness, weakness, and feeling light-headed. A slow heart rate isn’t always serious; but if it causes fainting, then your provider might ask you to pause or stop taking Thalomid (thalidomide). You can check your own heart rate at home between clinic visits and call your provider if you notice a change. You can check it at home with a blood pressure cuff, smart watch, or by counting your pulse for one minute. If you’re taking other medications that can also slow heart rate, such as a beta blocker, your provider might ask you to monitor your heart rate more often.
Serious skin and allergic reactions
Rarely, Thalomid (thalidomide) can cause serious skin problems, including severe skin reactions or infections that can be life-threatening, such as Stevens-Johnson syndrome (SJS) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Tell your provider right away if you develop painful blisters, skin wounds, peeling skin, or fever as these are signs of a serious skin reaction that need immediate medical attention.
In addition, some people taking Thalomid (thalidomide) have experienced a hypersensitivity reaction. Symptoms included rash, fever, fast heart beat, and low blood pressure. If you have any of these symptoms, contact your provider right away. You might need to pause taking Thalomid (thalidomide) while your provider looks into it.
Seizures
Some people have experienced seizures while taking Thalomid (thalidomide). Most of them also had a condition that put them at higher risk of seizures, such as epilepsy, and it’s not clear if taking Thalomid (thalidomide) contributed to the seizures. If you have a history of seizures your provider will monitor you closely while you’re taking Thalomid (thalidomide).
Tumor lysis syndrome
Tumor lysis syndrome is a complication that might happen in people taking Thalomid (thalidomide) for multiple myeloma. It can happen when cancer cells are destroyed and release what was inside the cells into the bloodstream. This can be dangerous because it can lead to high levels of uric acid and potassium in the blood, which can cause problems with your kidneys and heart. You’re most at risk for tumor lysis syndrome when you first start taking Thalomid (thalidomide). Your provider will monitor your lab tests very closely. If your lab results show signs of tumor lysis syndrome, you might need to pause Thalomid (thalidomide) while your provider manages it.
Risks with birth control
Different types of birth control can have risks, such as the risk of bleeding with an intrauterine device (IUD) or risk of blood clot with hormonal birth control pills. If you’re a female who can have children, you’re required to either abstain from sex or take effective birth control while taking Thalomid (thalidomide). If you choose to use birth control, you should talk with your provider and consider the risks that come with each birth control option before choosing which one is best for you.
Thalomid (thalidomide) dosage
Typical dosage for Thalomid (thalidomide)
Multiple myeloma
- The typical dose is 200 mg by mouth once a day at bedtime, taken together with dexamethasone as part of a 28-day treatment cycle.
Erythema nodosum leprosum
- Your provider will determine your dose based on body weight. The typical dose ranges from 100 mg to 300 mg by mouth once a day, ideally at bedtime. Usually, you'll continue treatment until symptoms go away (which can take at least 2 weeks). Once appropriate, your provider will lower your dose slowly over 2 to 4 weeks to help you safely stop this medication.
Interactions between Thalomid (thalidomide) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Thalomid (thalidomide) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Thalomid (thalidomide) will not be safe for you to take.
- Currently pregnant
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