Panobinostat, Oral

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KEY POINTS

• This medicine is taken by mouth to treat multiple myeloma. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause severe or life-threatening diarrhea, heart problems, bleeding, or liver problems. The medicine may also cause 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: antineoplastic (anticancer); histone deacetylase (HDAC) inhibitor

Generic and brand names: panobinostat, oral; Farydak

What is this medicine used for?

This medicine is taken by mouth to treat multiple myeloma. It is used along with other medicines after at least 2 other courses of treatment.

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
• Heart disease, angina (chest pain), or a heart attack
• High blood pressure
• Liver problems
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Long-term diarrhea
• Low or high levels of potassium, magnesium, or phosphorus in your blood

Tell your healthcare provider if you have any kind of infection

Men who receive this medicine should always use a condom when having sex with a woman who may become pregnant. Do this during treatment with this medicine and for 6 months after stopping treatment.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use a reliable form of birth control while you are taking this medicine and for 3 months after you stop taking it. Talk with your healthcare provider about effective birth control methods. Do not breast-feed while you are receiving this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

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. Do not stop taking this medicine without your healthcare provider's approval.

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

Take the medicine at the same time each day with a full glass of water. You may take it with or without food. Swallow each capsule whole. Do not chew or break open the capsule.

If capsules are accidentally opened or crushed, do not touch the capsules or the powder contents of the capsules. If the powder from an open or crushed capsule gets on your skin or in your eyes, rinse well with plenty of plain water. Call your healthcare provider.

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?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe diarrhea, nausea, vomiting, weakness.

What should I watch out for?

You will need to have regular checkups and blood tests to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause diarrhea, nausea, or vomiting and may increase the risk of dehydration. Contact your healthcare provider right away if you have severe nausea, vomiting, or diarrhea while you are taking this medicine. Do not take medicine to treat diarrhea without your provider's approval.

This medicine may cause life-threatening heart problems. Contact your healthcare provider right away if you have chest pain; fast, slow, or pounding heartbeat; lightheadedness; dizziness; shortness of breath; or swelling in your legs.

This medicine can cause severe bleeding that can lead to death. Contact your healthcare provider right away if you have unusual bruising or bleeding, dark or bloody urine or bowel movements, or vomiting or coughing up blood.

This medicine can cause liver problems. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests. Contact your healthcare provider right away if you develop loss of appetite; yellowish skin or eyes; dark urine; light-colored bowel movements; severe stomach pain; or severe tiredness. These are signs of possible liver damage.

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 while you are taking this medicine without getting your healthcare provider's approval first.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless 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.

Adults over the age of 65 may be at greater risk for side effects. 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); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; dark urine; light-colored bowel movements; yellowing of your eyes or skin; severe nausea, vomiting, or diarrhea; fever, chills, sore throat, or cough; unusual swelling, warmth, redness, swelling, pain, or tenderness in the leg; chest pain; fast, slow, or irregular heartbeat; severe dizziness or fainting; severe tiredness or weakness; shortness of breath; coughing up blood.

Other: Mild diarrhea, mild nausea or vomiting, joint swelling, trouble sleeping.

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:

• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), sulfamethoxazole/trimethoprim (Bactrim, Septra), telithromycin (Ketek), and tetracycline
• Antidepressants such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as carvedilol (Coreg) and metoprolol (Lopressor, Toprol)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), bexarotene (Targretin), bicalutamide (Casodex), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Chloroquine
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Live vaccines
• Lomitapide (Juxtapid)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), and netupitant/palonosetron (Akynzeo)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• St. John’s wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• 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.

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.

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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.