When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to panobinostat or you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole with water. Do not open, crush, break, or chew it.
• If you vomit after taking a dose, do not take another capsule. Wait and take your next dose at your usual time.
• Do not handle crushed or broken capsules. If the powder from the capsule gets on your skin, wash your skin with soap and water. If the powder gets in your eyes, rinse them with water.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it less than 12 hours until your next dose, skip the missed dose and take the next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the blister pack in the original carton to protect it from light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many medicines that can affect how panobinostat works. Make sure your doctor knows the names of all the medicines you use.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Also avoid eating star fruit or pomegranate or drinking pomegranate juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment and for 1 month after the last dose for women, and for 3 months after the last dose for men.
• Tell your doctor if you are breastfeeding, or if you have liver disease, bleeding problems, heart disease, heart rhythm problems, angina, or had recent heart attack.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  
  • Severe diarrhea
  • Heart or heart rhythm problems
  • Liver problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, fast, pounding, or uneven heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Red or dark brown urine, red or black stools, coughing up blood, vomiting blood or material that looks like coffee grounds
• Severe diarrhea
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea, nausea, vomiting
• Tiredness
• Weight loss

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088