WARNING

Taking Thalomid (thalidomide) carries several risks that patients should be aware of. These include:

• Birth Defects: Thalomid is highly teratogenic, meaning it can cause severe birth defects if taken during pregnancy. Women of childbearing age must use effective contraception while taking Thalomid and for a certain period after discontinuing the medication.
• Blood Clots: Thalomid increases the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients should be monitored for signs of blood clots, especially those with a history of blood clotting disorders.
• Peripheral Neuropathy: Thalomid can cause peripheral neuropathy, leading to tingling, numbness, or pain in the hands and feet. Regular monitoring for neuropathy symptoms is necessary, and dosage adjustments may be required if neuropathy develops.
• Sedation and Dizziness: Thalomid may cause drowsiness and dizziness, which can impair the ability to perform tasks requiring alertness, such as driving or operating machinery.
• Other Side Effects: Thalomid can cause various other side effects, including constipation, fatigue, skin reactions, nausea, vomiting, weakness, edema, decreased appetite, weight changes, mood changes, and liver toxicity.
• Drug Interactions: Thalomid may interact with other medications, potentially affecting their effectiveness or increasing the risk of side effects. It’s essential to inform healthcare providers about all medications being taken.
• Liver Toxicity: Thalomid can affect liver function, leading to liver toxicity. Regular monitoring of liver function tests may be necessary during treatment.
• Rare but Serious Reactions: In rare cases, Thalomid may cause severe allergic reactions, severe skin reactions, or other serious adverse events requiring immediate medical attention.

Patients should discuss the risks and benefits of Thalomid treatment with their healthcare provider and carefully follow all instructions provided. Regular monitoring and communication with healthcare providers are crucial for managing potential risks and optimizing treatment outcomes.

Why is this medication prescribed?

Thalomid, also known by its generic name thalidomide, is a medication that is prescribed for several medical conditions, primarily:

• Multiple Myeloma: Thalomid is approved for the treatment of multiple myeloma, a cancer of the plasma cells in bone marrow.
• Erythema Nodosum Leprosum (ENL): Thalomid is also used for the treatment of erythema nodosum leprosum, a painful skin condition associated with leprosy.

Thalomid works by affecting the immune system and by inhibiting the growth of blood vessels, which can help in treating cancer and reducing inflammation associated with certain skin conditions.

How should this medicine be used?

Thalomid (thalidomide) should be used exactly as prescribed by a healthcare professional. It’s essential to follow their instructions carefully. Here are some general guidelines for using Thalomid:

• Dosage: Take Thalomid exactly as directed by your doctor. The dosage prescribed will depend on your medical condition, response to treatment, and other factors. Do not change your dose unless instructed to do so by your doctor.
• Administration: Thalomid is typically taken orally, usually once daily. Swallow the capsules whole with a full glass of water. Do not crush, chew, or break the capsules.
• Timing: Thalomid can be taken with or without food. Follow your doctor’s instructions regarding whether to take it with meals or on an empty stomach.
• Consistency: Try to take Thalomid at the same time each day to maintain a consistent level of the medication in your bloodstream.
• Do Not Double Dose: If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
• Follow-up Appointments: Attend all scheduled appointments with your doctor for monitoring and evaluation of your condition. Your doctor may need to adjust your dosage or treatment plan based on your response to Thalomid.
• Contraception: If you are a female of reproductive potential, you must use effective contraception during treatment with Thalomid and for a certain period after discontinuing the medication, as specified by your healthcare provider. This is to prevent the risk of severe birth defects.
• Adherence to Instructions: Always follow any additional instructions provided by your doctor or pharmacist regarding the use of Thalomid.
• Potential Side Effects: Be aware of potential side effects of Thalomid, and promptly report any new or worsening symptoms to your doctor.
• Storage: Store Thalomid at room temperature away from moisture and heat. Keep it out of the reach of children and pets.

It’s important to have open communication with your healthcare provider throughout your treatment with Thalomid. If you have any questions or concerns about how to use the medication, don’t hesitate to discuss them with your doctor or pharmacist.

Other uses for this medicine

Some of these off-label uses may include:

• Crohn’s Disease: Thalomid may be used in some cases to treat symptoms of Crohn’s disease, particularly for patients who have not responded well to other therapies.
• Behçet’s Disease: Thalomid may be used to manage symptoms of Behçet’s disease, a rare inflammatory disorder that can affect multiple parts of the body.
• Various Cancers: Thalomid may be considered in the treatment of certain cancers, such as myelodysplastic syndromes (MDS) and certain types of solid tumors, although its use in these cases is less common and requires careful evaluation by a healthcare provider.

What special precautions should I follow?

Regarding special precautions for using Thalomid, there are several important considerations:

• Pregnancy Category X: Thalomid is known to cause severe birth defects if taken during pregnancy. It should not be used by pregnant women or women who may become pregnant unless there is a clear medical need and appropriate measures are taken to prevent pregnancy. Effective contraception must be used by females of reproductive potential during treatment with Thalomid and for a certain period after discontinuation of the medication.
• Blood Clotting Risk: Thalomid increases the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients should be monitored for signs and symptoms of blood clots, and appropriate precautions should be taken, especially in individuals with a history of blood clotting disorders.
• Peripheral Neuropathy: Thalomid can cause peripheral neuropathy, which is characterized by tingling, numbness, or pain in the hands and feet. Patients should be monitored for signs of neuropathy, and dosage adjustments or discontinuation of the medication may be necessary if neuropathy develops.
• Drowsiness and Dizziness: Thalomid may cause drowsiness and dizziness. Patients should use caution when driving or operating machinery until they know how the medication affects them.
• Liver Function: Thalomid can affect liver function, so liver function tests may be performed periodically during treatment.
• Drug Interactions: Thalomid may interact with other medications, including certain sedatives, antidepressants, and drugs that affect blood clotting. Inform your healthcare provider about all medications you are taking to avoid potential interactions.
• Monitoring and Follow-up: Regular monitoring and follow-up appointments with your healthcare provider are essential to monitor for any potential side effects or complications associated with Thalomid use.

It’s crucial to discuss any concerns or questions about Thalomid and its potential risks and benefits with your healthcare provider before starting treatment.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Thalomid. However, it’s essential to maintain a balanced and healthy diet to support overall well-being and treatment effectiveness.

What should I do if I forget a dose?

• If you forget to take a dose of Thalomid, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule.
• Do not double the dose to make up for a missed one.
• If you have questions or concerns about missed doses, consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Thalomid (thalidomide) can cause various side effects, ranging from mild to severe. It’s essential to be aware of these potential side effects and to promptly report any new or worsening symptoms to your healthcare provider. Some common side effects of Thalomid include:

• Sedation: Thalomid can cause drowsiness or dizziness, which may impair your ability to perform certain tasks safely, such as driving or operating machinery.
• Peripheral Neuropathy: Thalomid can lead to peripheral neuropathy, which may cause tingling, numbness, or pain, typically in the hands and feet.
• Constipation: Some individuals may experience constipation while taking Thalomid.
• Fatigue: Feeling tired or fatigued is a common side effect of Thalomid.
• Skin Reactions: Thalomid may cause skin reactions, such as rash or dry skin.
• Nausea and Vomiting: Some people may experience nausea or vomiting while taking Thalomid.
• Weakness: Thalomid can cause weakness or muscle weakness in some individuals.
• Edema: Swelling (edema), particularly in the legs and feet, can occur as a side effect of Thalomid.
• Decreased Appetite: Thalomid may lead to a decreased appetite or loss of appetite in some individuals.
• Weight Changes: Weight gain or weight loss can occur while taking Thalomid.
• Mood Changes: Thalomid may affect mood, leading to mood swings or changes in emotional well-being.
• Blood Clots: Thalomid increases the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Birth Defects: Thalomid is highly teratogenic, meaning it can cause severe birth defects if taken during pregnancy. This is why strict pregnancy prevention measures are essential for individuals of reproductive potential.
• Other Serious Side Effects: In rare cases, Thalomid may cause more severe side effects, including severe allergic reactions, liver toxicity, or severe skin reactions.

It’s important to discuss any concerns or questions about side effects with your healthcare provider. They can provide guidance on managing side effects and help determine if Thalomid is the right treatment for you. Additionally, if you experience any severe or concerning side effects, seek medical attention promptly.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage:
  • Store Thalomid at room temperature, away from moisture and heat.
  • Keep the medication in its original container, tightly closed, and out of reach of children and pets.
  • Do not store Thalomid in the bathroom or near the kitchen sink, where it could be exposed to moisture.
• Disposal:
  • Dispose of unused or expired Thalomid properly according to local regulations or guidelines.
  • Do not flush Thalomid down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist.
  • Consult your pharmacist or local waste disposal facility for information on how to dispose of Thalomid safely.

In case of emergency/overdose

• In case of an overdose or emergency, such as accidental ingestion of too much Thalomid, seek immediate medical attention or contact a poison control center.
• Symptoms of overdose may include severe drowsiness, confusion, difficulty breathing, seizures, or unconsciousness.
• Be prepared to provide information about the amount of Thalomid ingested and any symptoms experienced.

What other information should I know?

• Keep all appointments with your healthcare provider for monitoring and evaluation of your condition while taking Thalomid.
• Inform all healthcare providers involved in your care that you are taking Thalomid, including dentists and surgeons, as it may interact with other medications or affect certain medical procedures.
• Carry a medical identification card or wear a medical alert bracelet to inform emergency personnel that you are taking Thalomid, especially if you have a history of severe allergic reactions or other medical conditions.
• Be aware of the potential side effects of Thalomid and report any new or worsening symptoms to your healthcare provider promptly.
• Follow all instructions provided by your healthcare provider regarding the use of Thalomid, including dosage, administration, and precautions.

It’s essential to be well-informed about the proper storage, disposal, and handling of emergencies or overdoses involving Thalomid to ensure safe and effective use of the medication. If you have any questions or concerns about Thalomid, consult your healthcare provider or pharmacist for guidance.