Panobinostat is a prescription medication used to treat multiple myeloma. Panobinostat belongs to a group of drugs called HDAC inhibitors. These work by slowing the over-development of plasma cells in multiple myeloma patients or causing these dangerous cells to die.

This medication is available as an oral capsule and is usually taken once every other day during the first 2 weeks of a 3-week chemotherapy cycle. Treatment should be continued for 8 cycles. Do not crush, chew, or open the capsules. Swallow panobinostat capsules whole.

Common side effects of panobinostat include diarrhea, nausea, swelling of the extremities, fever, and vomiting. Panobinostat can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how panobinostat affects you.

Panobinostat is a prescription medication used to treat multiple myeloma. Panobinostat is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose of panobinostat for the treatment of multiple myeloma is 20 mg every other day for 3 doses per week during weeks 1 and 2 of a 3-week chemotherapy cycle. Treatment may be continued for up to 8 cycles.

WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES

Severe diarrhea occurred in 25% of panobinostat treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt panobinostat and then reduce dose or discontinue panobinostat.

Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving panobinostat. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.

Serious side effects have been reported with panobinostat including the following:

• Hemorrhage, including gastrointestinal and pulmonary bleeding
• Liver toxicity and abnormal liver function
• Embryo and fetal toxicity

Panobinostat can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how panobinostat affects you.

Do not take panobinostat if you are:

• allergic to panobinostat or to any of its ingredients

Serious side effects have been reported with panobinostat. See the “Panobinostat Precautions” section.

Common side effects of panobinostat include the following:

• diarrhea
• tiredness
• nausea
• swelling in the arms or legs
• decreased appetite
• fever
• vomiting
• weakness
• changes in blood counts
• low potassium
• low sodium in the blood (hyponatremia)

This is not a complete list of panobinostat side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• atomoxetine (Strattera)
• bepredil (Vascor)
• boceprevir (Victrelis)
• chloroquine
• clarithromycin (Biaxin)
• conivaptan (Vaprisol)
• desipramine (Norpramin)
• dextromethorphan (Delsym)
• dolasetron(Anzemet)
• halofantrine (Halfan)
• indinavir (Crixivan)
• itraconazole (Onmel, Sporanox)
• ketoconazole (Nizoral)
• lopinavir/ritonavir (Kaletra)
• methadone (Methadose, Diskets)
• metoprolol (Lopressor)
• moxifloxacin (Vigamox, Avelox, Moxeza)
• nebivolol (Bystolic)
• nefazadone (Serzone)
• nelfinavir (Viracept)
• ondansetron (Zupenz, Zofran)
• perphenazine
• pimozide (Orap)
• posaconazole (Noxafil)
• ritonavir (Norvir, in Kaletra)
• saquinavir (Fortovase, Invirase)
• telaprevir (Incivek)
• telithromycin (Ketek)
• thioridazine
• tolterodine (Detrol)
• tropisetron (Navoban)
• venlafaxine (Effexor)
• voriconazole (Vfend)

This is not a complete list of panobinostat drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

Panobinostat can cause fetal harm if administered to pregnant women. Women should perform a pregnancy test before beginning panobinostat and intermittently during treatment to confirm that they are not pregnant. Females should avoid becoming pregnant while taking panobinostat and for at least 1 month after the last dose of panobinostat. Males should avoid use condoms while taking panobinostat and for up to 3 months after the last dose of panobinostat.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if panobinostat crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using panobinostat.