panobinostat

What is the most important information I should know about panobinostat?

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.

What is panobinostat?

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.

What should I discuss with my healthcare provider before taking panobinostat?

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.

• 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.

How should I take panobinostat?

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.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking panobinostat?

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

What are the possible side effects of panobinostat?

• 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.

• 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 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.

What other drugs will affect panobinostat?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about panobinostat.