Panobinostat oral capsule

What is this medication?

PANOBINOSTAT (pan oh bin oh stat) is a chemotherapy drug that targets a specific protein within cancer cells and stops the cancer cells from growing. It is used to treat multiple myeloma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): FARYDAK

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• diarrhea
• heart disease
• history of low blood counts caused by a medicine
• infection
• liver disease
• low levels of potassium or magnesium in the blood
• an unusual or allergic reaction to panobinostat, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. You can take this medicine with or without food. However, you should always take it the same way each time. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Do not take with star fruit, pomegranate juice, or grapefruit juice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses. If you vomit after taking a dose, do not take another dose on that day. Take your next dose at your regular time.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• fluconazole
• pimozide
• posaconazole
• thioridazine
• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS
• atomoxetine
• carbamazepine
• chloroquine
• clarithromycin
• conivaptan
• desipramine
• dextromethorphan
• dofetilide
• dolasetron
• enzalutamide
• fungal infection medicines like ketoconazole, itraconazole, voriconazole
• grapefruit juice
• medicines for irregular heart beat like amiodarone, disopyramide, procainamide, quinidine, sotalol
• methadone
• metoprolol
• moxifloxacin
• nebivolol
• nefazodone
• ondansetron
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• perphenazine
• phenobarbital
• phenytoin
• pomegranate juice
• primidone
• rifampin
• Star fruit
• St. John's Wort
• telaprevir
• telithromycin
• tolterodine
• venlafaxine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 3 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 6 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• confusion
• diarrhea
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding
• severe headaches
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• stomach pain
• swelling of the legs or ankles
• trouble speaking or understanding

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• loss of appetite
• nausea, vomiting
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the blister pack in the original container until the time of use. Protect from light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.