Romidepsin (By injection)

Istodax

Injectable

• 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 at least 4 hours.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

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

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

• 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. Your doctor will give you a pregnancy test within 7 days before starting this medicine. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms, IUD, spermicide) along with your pills. Use an effective form of birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 month after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis B), heart or blood vessel disease, heart rhythm problems, or any type of infection.
• This medicine may cause the following problems:
  • Increased risk for serious infections
  • Heart rhythm problems
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
• 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 make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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.

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 feeling during urination, bloody urine, lower back or side pain
• Chest pain, troubled breathing
• Diarrhea, nausea, vomiting, stomach pain
• Fast, pounding, or uneven heartbeat, dizziness, lightheadedness, or fainting
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

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

• Change or loss of taste
• Constipation, loss of appetite, decreased weight

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088