Thalidomide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat and prevent new attacks of leprosy, or to treat multiple myeloma. Take it exactly as directed.
• DO NOT take this medicine if you are pregnant or plan to become pregnant while taking this medicine. This medicine causes severe birth defects or death to an unborn baby.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause nerve damage, blood clots, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immunosuppressant

Generic and brand names: thalidomide, oral; Thalomid

What is this medicine used for?

This medicine is taken by mouth to treat and prevent new attacks of leprosy. This medicine is also taken to treat multiple myeloma.

This medicine causes severe birth defects or death to an unborn baby. Only a few healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. For information on the distribution of this medicine, call 1-888-423-5436.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Blood clots
• Heart disease
• HIV infection
• Kidney or liver disease
• Nerve problems
• Seizures

DO NOT take this medicine if you are pregnant or plan to become pregnant while taking this medicine. You must stop taking this medicine and contact your healthcare provider immediately:

• If you become pregnant while taking this medicine
• If you miss a menstrual period or have unusual menstrual bleeding
• If you stop using birth control
• If you think that you may be pregnant

How do I take it?

Read the Medication Guide before you start treatment with this medicine and each time you get a new prescription.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. This medicine is usually taken at bedtime, at least 1 hour after the evening meal.

Check with your healthcare provider before using this medicine in children under age 12.

Keep the medicine in the medicine package until you are ready to take it. Swallow the capsules whole. Do not break, crush, or chew the capsules. Do not open the capsules or handle the capsules more than necessary. If your skin comes in contact with the capsules, wash your skin with soap and water.

What if I miss a dose?

If you miss a dose, and it is more than 12 hours until the next scheduled dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

Females of childbearing age: DO NOT take this medicine if you are pregnant. The baby may die or be born with serious birth defects. You must have a negative pregnancy test within 24 hours before you start taking this medicine. You will need a pregnancy test weekly during the first 4 weeks of treatment, and then every 4 weeks if you have regular menstrual cycles or every 2 weeks if you have irregular menstrual cycles. You must use 2 reliable methods of birth control such as birth control pills and condoms or a diaphragm. Many medicines may make hormonal birth control less effective. Tell your healthcare provider about all the medicines and natural products you take, and discuss birth control with your healthcare provider.

Males: Use condoms during sexual intercourse with females of childbearing age, even if you have had a successful vasectomy.

Males and females must use these birth control methods:

• For at least 4 weeks before starting this medicine
• During any breaks (interruptions) in your treatment with this medicine
• While taking this medicine
• For at least 4 weeks after stopping this medicine

Do not donate blood, semen, or sperm while taking this medicine, during breaks in treatment, or for 1 month before or after taking this medicine.

This medicine may increase your risk of developing blood clots. These can be either deep vein thrombosis, or a clot in the lung. While taking this medicine, you may also need to take medicine to thin your blood and help prevent blood clots. If you have multiple myeloma, this medicine also increases your risk for a heart attack or stroke.

You must sign a consent form after your healthcare provider explains the risks of taking this medicine. You will need a copy of the consent form and the prescription to give to the pharmacist at a pre-registered pharmacy. You cannot get more than one 28-day supply of this medicine. See your healthcare provider every 28 days for an exam and a new prescription, if needed.

This medicine may cause nerve damage that may be severe and permanent. This may happen at any time during or after your treatment. If you have any numbness, burning, tingling, or pain in your hands or feet, contact your healthcare provider right away.

If you are HIV positive, this medicine may increase the HIV virus in your blood. If you have cancer, you may be a risk for fast breakdown of cancer cells while taking this medicine (Tumor Lysis Syndrome). Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. Talk with your healthcare provider about this.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery until you are fully alert. You may also become dizzy and feel faint when you get up from sitting or lying down. Getting up slowly may help lessen this reaction.

This medicine increases the effects of alcohol and other medicines that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Your healthcare provider will see you regularly while you are taking this medicine. You will also need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine is present in your blood and other body fluids. Anyone who may come in contact with your blood or other body fluids should wear gloves or wash any of their exposed areas of skin with soap and water.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe leg pain or feeling of warmth in the calves; swelling of the legs, arms, hands, or feet; shortness of breath; coughing up blood; unusual bruising or bleeding; trouble urinating chest pain; severe drowsiness or dizziness; fast, slow, or irregular heartbeat; fever over 105.5°F, or 40.8°C; cough; sore throat; numbness, burning, pain, or tingling in your hands or feet; severe skin rash, redness, peeling, or blistering; confusion; anxiety; depression or mood changes; weakness; seizures.

Other: Mild skin rash; diarrhea, nausea, headache, tiredness, drowsiness, dizziness, sweating, constipation, trouble sleeping, muscle or joint pain, change in appetite, dry skin, tremors, trouble having and keeping an erection (for males).

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Abatacept (Orencia)
• Alcohol
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Anakinra (Kineret)
• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), fexofenadine (Allegra), and loratadine (Alavert, Claritin)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Dexamethasone
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Lithium (Lithobid)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and famotidine (Pepcid)
• Medicines to treat bone loss such as alendronate (Binosto, Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate, risedronate (Actonel, Atelvia), and zoledronic acid (Reclast, Zometa)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Natural remedies such as cat's claw, echinacea, garlic, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other medicines that may cause numbness or pain in the hands or feet such as amiodarone (Cordarone, Pacerone), bortezomib (Velcade), cisplatin, didanosine (Videx), disulfiram (Antabuse), docetaxel (Docefrez, Taxotere), leuprolide (Lupron), metronidazole, nitrofurantoin (Furadantin, Macrobid, Macrodantin), paclitaxel (Abraxane, Taxol), vincristine (Marqibo), and zalcitabine (Hivid)
• Pain medicines such as codeine (Tylenol #3), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, temazepam (Restoril), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Vaccines

Do not drink alcohol while taking this medicine unless your healthcare provider approves

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

Return any unused medicine to your healthcare provider or pharmacist.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw this medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.