Panobinostat

Panobinostat is used together with other drugs to treat multiple myeloma in adults who have already had at least two different types of treatment.

Panobinostat may also be used for reasons not mentioned in this medication guide.

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

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

Take it with a full glass of water at the same time each 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 capsule 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 receive 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.

Panobinostat can lead to serious or life-threatening heart issues. Seek medical help if you experience chest pain, rapid or slow heartbeats, dizziness or fainting, swelling in your legs, blue lips, or trouble breathing.

Contact your doctor if you have severe diarrhea or stomach cramps, or if you become dehydrated (increased thirst, less urination, sweating, or hot and dry skin).

Inform your doctor immediately if you have any bleeding that won’t stop, blood in your urine or stools, dizziness, confusion, vomiting, or coughing up blood.

Tell your doctor if you have diarrhea, or if you've ever had:

• heart problems, like long QT syndrome;
• any type of infection;
• bleeding problems; or
• liver disease.

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

• If you are a woman, you may need to take a pregnancy test that shows you are not pregnant 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 can get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor immediately if a pregnancy happens while either the mother or the father is using panobinostat.

You should not breastfeed while taking this medicine.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 faint;
• blue-colored lips;
• swelling in your lower legs; or
• shortness of breath.

Panobinostat may cause serious side effects. Call your doctor right away 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;
• symptoms of dehydration--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.

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

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.

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.

Panobinostat can lead to a serious heart issue. Your risk may increase if you are also taking specific other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other medications may impact panobinostat, including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medications and any new medicine you begin or stop using.