Pomalidomide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat multiple myeloma. Take it exactly as directed.
• This medicine may cause birth defects or the baby may die if you or your partner get pregnant. DO NOT take this medicine if you are pregnant.
• This medicine may increase your risk of developing serious blood clots. While taking this medicine, you may also need to take medicine to help prevent blood clots. Do not donate blood while taking this medicine and for 4 weeks after you stop taking this medicine.
• This medicine may cause 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: immunomodulator; antineoplastic (anticancer)

Generic and brand names: pomalidomide, oral; Pomalyst

What is this medicine used for?

This medicine is taken by mouth to treat multiple myeloma in people who have not responded to other medicines.

This medicine causes severe birth defects or death to an unborn baby. In order for you to receive this medicine, you must be enrolled in a special program. You must sign a consent form after your healthcare provider explains the risks of taking this medicine. You cannot get more than a 28-day supply of this medicine at one time. Your healthcare provider will explain this special program to you.

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 or bleeding problems
• Immune system problems such as AIDS or HIV
• Kidney or liver disease
• Nerve problems

Tell your healthcare provider if you smoke. Smoking may make this medicine less effective.

Females of childbearing age: DO NOT take this medicine if you are pregnant. You must stop taking this medicine and contact your healthcare provider immediately if you:

• Become pregnant while taking this medicine
• Miss a menstrual period or have unusual menstrual bleeding
• Stop using birth control
• Think that you may be pregnant

Males: If your female partner becomes pregnant, you should call your healthcare provider right away. Do NOT donate sperm.

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.

Check with your healthcare provider before using this medicine in children under age 18.

Keep the medicine in the medicine package until you are ready to take it. Swallow the capsules whole with a full glass of water. Do not break, crush, or chew the capsules. Do not open the capsules or handle them more than necessary.

If your skin comes in contact with the capsules, wash your skin with soap and water right away. 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.

Take this medicine on an empty stomach, 2 hours before or 2 hours after a meal. Take this medicine at about the same time each day.

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?

Symptoms of an acute overdose have not been reported.

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 2 negative pregnancy tests before starting 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. Start using these birth control methods 1 month before you start taking this medicine. Use them while you are taking this medicine, if you stop and then restart treatment with this medicine, and for 1 month after you stop taking it. 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 while you are taking this medicine, if you stop and then restart treatment with this medicine, and for 4 weeks after you stop taking the medicine, even if you have had a successful vasectomy. Do not donate sperm while taking this medicine, if you stop and then restart treatment with this medicine, and for 4 weeks after you stop taking the medicine.

Do NOT donate blood while taking this medicine and for 4 weeks after you stop taking this medicine. If someone who is pregnant gets your donated blood, her baby may be exposed to this medicine and may be born with birth defects.

This medicine may increase your risk of developing serious blood clots. While taking this medicine, you may also need to take medicine to help prevent blood clots. Call your healthcare provider or get medical help right away if you have any signs of a blood clot in your veins or lungs, such as:

• Shortness of breath
• Chest pain
• Arm or leg swelling, pain, redness, or a feeling of warmth

This medicine may cause a second type of cancer. Talk with your provider about this.

This medicine may cause fever, infection, or anemia. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause the fast breakdown of certain types of cancer cells. Call your healthcare provider right away if you have a fast or abnormal heartbeat, trouble passing urine, muscle weakness or cramps, severe vomiting or diarrhea, or feel sluggish.

This medicine may make you confused or dizzy. Do not drive or operate machinery until you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine may increase 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.

You need to have blood tests and checkups regularly while you are taking this medicine. Keep all appointments.

Do NOT share this medicine with other people. It may cause birth defects and other serious problems.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

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.): Arm or leg pain or feeling of warmth in the calves; swelling of the legs, arms, hands, or feet; shortness of breath; coughing up blood; chest pain; severe drowsiness or dizziness; slow, fast, or irregular heartbeat; yellowing of your skin or eyes; dark urine; light-colored bowel movements; decreased urination; fever; cough; sore throat; trouble breathing; numbness, burning, pain, or tingling in your hands or feet; confusion; unusual tiredness or weakness; unusual bruising or bleeding.

Other: Skin rash; diarrhea, nausea, headache, tiredness, drowsiness, dizziness, anxiety, sweating, constipation, trouble sleeping, back pain, muscle or joint pain, change in appetite, dry skin, tremors.

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:

• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), ofloxacin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), fexofenadine (Allegra), and loratadine (Alavert, Claritin)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), mitotane (Lysodren), nilotinib (Tasigna), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), gemfibrozil (Lopid), and lomitapide (Juxtapid)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), dronedarone (Multaq), mexiletine, nicardipine (Cardene), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), leflunomide (Arava), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natalizumab (Tysabri)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), prochlorperazine (Compro), and promethazine
• 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)
• Simeprevir (Olysio)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), temazepam (Restoril), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Vaccines

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

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 drug manufacturer or your healthcare provider. Talk with your healthcare provider or pharmacist about this.

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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 medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.