Pronunciation:

tha-LID-oh-mide

Brand Names:

• Thalomid

Dosage Forms:

• Capsule

Warnings:

Thalidomide can cause severe birth defects or embryofetal death, even with 1 dose, if taken during pregnancy. Thalidomide distribution is restricted through the THALOMID REMS(TM) program (formerly known as the S.T.E.P.S.(R) program). The use of thalidomide in multiple myeloma patients results in an increased risk of VTE , such as DVT and pulmonary embolism. Coadministration of dexamethasone increases this risk. Monitor for thromboembolism and consider thromboprophylaxis for individualized cases .

Classifications:

Therapeutic—

Leprostatic

Uses of This Medicine:

Thalidomide is used to treat and prevent erythema nodosum leprosum, a painful skin disease associated with leprosy. It is also used together with dexamethasone (eg, Decadron®) to treat patients with multiple myeloma (a cancer of the blood). Thalidomide works on the immune system to reduce inflammation. It also interferes with the growth of multiple myeloma cells, which are eventually destroyed in the body. Thalidomide is an antineoplastic (cancer medicine) and leprostatic agent.

This medicine is available only under a restricted distribution program called the Thalomid® REMS (Risk Evaluation and Mitigation Strategy) program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of thalidomide in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thalidomide in the elderly. However, elderly patients are more likely to have unwanted effects (eg, blood clotting problems, heart rhythm problem), which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

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.

• Dexamethasone
• Docetaxel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots or
• Bradycardia (slow heartbeat) or
• HIV infection or
• Neutropenia (low white blood cells) or
• Peripheral neuropathy (nerve problem) or
• Seizures, history of or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Deep vein thrombosis (blood clot in leg), history of or
• Heart attack, history of or
• Pulmonary embolism (blood clot in lung), history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is very important that you understand the rules of the Thalomid® REMS program. Read the patient Medication Guide. Ask your doctor or pharmacist if you have any questions. You might be asked to sign a form to show that you understand the information.

Take this medicine with water at least 1 hour after the evening meal, preferably at bedtime.

Do not open the blister pack with the capsule until you are ready to take it. Do not break, chew, or open it. If you accidentally open the capsule and have contact with the powder, wash your skin with soap and water. If the medicine gets into your eyes, nose, or mouth, rinse them with water.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For erythema nodosum leprosum:
    • Adults and children 12 years of age and older—At first, 100 to 300 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For multiple myeloma:
    • Adults and children 12 years of age and older—200 milligrams (mg) once a day together with dexamethasone. The dose is repeated every 28 days.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can, then take your next dose at the normal time.

If you miss a dose and it has been more than 12 hours since your scheduled dose, skip the missed dose and take your next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Return unused capsules to your doctor or pharmacist.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for unwanted effects.

Women should take the necessary precautions to avoid pregnancy while taking thalidomide. Begin 2 forms of effective birth control together 4 weeks before starting treatment, during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner. Call your doctor right away if you think you are pregnant.

Women who can get pregnant must have a negative pregnancy test before starting treatment with this medicine. Pregnancy tests may be done weekly for the first month during treatment, and then every 2 to 4 weeks.

Men who are sexually active must protect their female partner from getting pregnant. Thalidomide will appear in the semen of male patients. If you are sexually active, you must use a latex or synthetic condom every time you have sex with a woman who could get pregnant. If you have had a vasectomy, you still have to use a latex condom during sex. You must use a condom during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Call your doctor right away if you think your sexual partner may be pregnant.

Do not donate blood or sperm while you are taking this medicine and for at least 4 weeks after your last dose.

You must not share this medicine with anyone, even someone who has similar symptoms.

This medicine may increase your risk of having blood clots, a heart attack, or stroke. Check with your doctor right away if you have shortness of breath, chest pain, or leg pain or swelling. These could be symptoms of blood clots. Symptoms of stroke include confusion, difficulty with speaking, double vision, inability to move the arms, legs, or facial muscles, or slow speech.

Do not receive pembrolizumab together with thalidomide and dexamethasone if you have multiple myeloma.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.

Thalidomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause nerve damage. Check with your doctor right away if you have tingling, burning, numbness, or pain in your hands or feet. These could be symptoms of a nerve condition called peripheral neuropathy.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Thalidomide may cause a serious type of reaction called tumor lysis syndrome in patients with multiple myeloma. Call your doctor right away if you have less urine than normal, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using thalidomide.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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

Anxiety

black, tarry stools

chest pain

chills

confusion

cough

dizziness or lightheadedness

dry mouth

fainting

fast heartbeat

fever

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

sore throat

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:

More common

Constipation

dry skin

diarrhea

dizziness

drowsiness

loss of appetite

nausea

stomach pain

weight changes

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.