When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to romidepsin, or if you are pregnant.

How to Use This Medicine:
Injectable

• 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.
• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine is usually given on days 1, 8, and 15 of a 28-day cycle of treatment. Each treatment takes about 4 hours.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

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

• Some foods and medicines can affect how romidepsin works. Tell your doctor if you are using the following:
  
  • Dexamethasone, nefazodone, St John's wort
  • A blood thinner (such as warfarin)
  • Medicine for heart rhythm problems
  • Medicine for tuberculosis (rifabutin, rifampin, rifapentine)
  • Medicine to treat HIV or AIDS (atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat an infection (clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole)
  • Medicine to treat seizures (carbamazepine, phenobarbital, phenytoin)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease (including hepatitis B), heart disease or heart rhythm problems, or any type of infection.
• This medicine may cause the following problems:
  
  • Heart rhythm problems
  • Tumor lysis syndrome
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often. Infections could be severe or even life-threatening.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• 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.

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
• Change in how much or how often you urinate, burning during urination
• Chest pain, shortness of breath
• Fast, pounding, or uneven heartbeat, dizziness, lightheadedness
• Fever, chills, cough, sore throat, and body aches
• Unusual bleeding, bruising, or weakness

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

• Change or loss of taste
• Diarrhea, constipation, loss of appetite, or stomach pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Tiredness

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