Panobinostat is used in combination with other drugs to treat multiple myeloma in adults who have received at least two other types of treatment.

Panobinostat may also be used for purposes not listed in this medication guide.

Panobinostat can cause serious or fatal heart problems. Get medical attention if you have chest pain, fast or slow heartbeats, dizziness or fainting, swelling in your legs, blue lips, or shortness of breath.

Call your doctor if you have severe diarrhea or stomach cramps, or if you get dehydrated (increased thirst, decreased urination, sweating or hot and dry skin).

Tell your doctor right away if you have any bleeding that will not stop, blood in your urine or stools, dizziness, confusion, vomiting or coughing up blood.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Panobinostat is usually taken 3 times per week until your doctor tells you to stop the medicine.

Take with a full glass of water at the same time of day, with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it. Do not use a broken capsule. If the medicine from a broken pill gets in your eyes or on your skin, wash your skin with soap and water or rinse your eyes with water.

If you vomit shortly after taking panobinostat, do not take another capsule. Take your next dose as scheduled.

Panobinostat can cause severe diarrhea or dehydration. You may be given medications to help prevent diarrhea or other side effects. Use these medicines for as long as your doctor has prescribed.

You will need frequent medical tests and your treatment may be delayed based on the results.

Store the blister pack inside the original carton at room temperature, away from moisture, heat, and light. Remove a capsule only when you are ready to take it.

Usual Adult Dose for Multiple Myeloma:

-Initial dose: 20 mg orally once every other day for 3 doses per week (on Days 1, 3, 5, 8, 10, 12) in Weeks 1 and 2 of each 21-day cycle for up to 8 cycles

-Duration of therapy: Up to 16 cycles (48 weeks)

Comments:
-Consider continuing treatment of this drug for an additional 8 cycles (16 cycles total) for patients with clinical benefit who do not experience unresolved severe or medically significant toxicity.
-This drug is administered in combination with bortezomib and dexamethasone. Consult manufacturer product information for the recommended dosing for these two drugs.

Use: Treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent

Tell your doctor if you are sick with diarrhea, or if you've ever had:

• heart problems, such as long QT syndrome;

• any type of infection;

• bleeding problems; or

• liver disease.

Panobinostat can harm an unborn baby if the mother or the father is using panobinostat.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using panobinostat.

You should not breastfeed while using this medicine.

Panobinostat is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not eat pomegranate, grapefruit or star fruit or drink grapefruit or pomegranate juice while taking this medication.

Certain foods may interact with panobinostat and cause side effects. Avoid eating star fruit, pomegranate, and grapefruit products while taking panobinostat.

Avoid using a laxative or stool softener. These could make diarrhea worse.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Panobinostat can cause serious or fatal heart problems. Get medical attention if you have:

• chest pain, fast or slow heartbeats;

• dizziness, or feeling like you might pass out;

• blue-colored lips;

• swelling in your lower legs; or

• shortness of breath.

Panobinostat may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea or stomach cramps;

• easy bruising or bleeding, bleeding that will not stop;

• signs of bleeding inside your body--headache, dizziness, confusion; pink or brown urine; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, cold hands and feet;

• signs of infection--fever, chills, sweating, trouble breathing, cough with mucus, skin sores, feeling very tired;

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or

• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of panobinostat may include:

• nausea, vomiting, loss of appetite;

• fever; or

• swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Panobinostat can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect panobinostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.