Precautions and Warnings With Romidepsin

• Liver disease, such as hepatitis, cirrhosis, or liver failure
• Kidney disease, such as kidney failure
• Nausea, vomiting, or diarrhea
• Low blood cell counts, such as low red blood cells, white blood cells, or platelets
• Anemia
• An infection or get infections easily
• Heart disease
• An irregular heartbeat or a problem known as QT prolongation or congenital long QT syndrome
• Been told you have low or high potassium or magnesium levels
• Any allergies, including to foods, dyes, or preservatives.

• Pregnant or thinking of becoming pregnant
• Breastfeeding.

• Romidepsin can decrease the number of red blood cells, white blood cells, and platelets in your blood. This could lead to serious problems, such as:

• Anemia from low red blood cells, which could cause extreme fatigue, pale skin, and shortness of breath
• An increased risk for infection from low white blood cells
• Abnormal bruising or bleeding from low platelets.

Your healthcare provider will monitor your blood cell counts throughout treatment. Be sure to tell him or her if you experience signs of anemia, believe you may have an infection, or have any unusual bruising or bleeding.

• You may be at risk for life-threatening infections, including pneumonia and blood infections, during treatment and for up to 30 days after treatment ends. Some people died from infections during romidepsin treatment. Your risk for life-threatening infections is higher if you have received intensive chemotherapy in the past. Tell your healthcare provider right away if you develop signs of an infection, such as:

• Fever
• Aches and pains
• Cough
• Shortness of breath
• Sore throat.

• Romidepsin has been reported to cause changes in the normal rhythm of the heart. People who have heart disease, a heart rhythm problem known as QT prolongation, or take QT-prolonging medicines (see Drug Interactions With Romidepsin) may have a higher risk for heart rhythm problems. Your healthcare provider may choose to check your electrolytes, such as potassium and magnesium, with a blood test and your heart with an electrocardiogram (ECG) before you begin treatment. Tell your healthcare provider if you experience problems such as:

• An abnormal heartbeat
• Dizziness
• Fainting
• Chest pain
• Shortness of breath during treatment.

• There have been reports of tumor lysis syndrome (the development of metabolic and electrolyte disturbances caused by the breakdown of tumor cells in people undergoing cancer treatment) in people using this medicine. Tumor lysis syndrome can lead to life-threatening complications. People who have many tumors, or who have more advanced cancer, are at a higher risk for this complication and should be monitored closely.

• Romidepsin may react with a number of other medications (see Drug Interactions With Romidepsin).

• Romidepsin is a pregnancy Category D medication, which means it may harm an unborn child if used during pregnancy (see Istodax and Pregnancy).

• It is unknown whether romidepsin passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Istodax and Breastfeeding).