romidepsin

What is the most important information I should know about romidepsin?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is romidepsin?

Romidepsin is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma).

Romidepsin is given after at least one other cancer treatment did not work or has stopped working.

Romidepsin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving romidepsin?

Tell your doctor if you have ever had:

• heart problems or a heart rhythm disorder;
• long QT syndrome (in you or a family member);
• kidney disease;
• liver disease (especially hepatitis B);
• an electrolyte imbalance (such as high or low levels of potassium or magnesium in your blood); or
• if you are sick with nausea, vomiting, or diarrhea.

You may need to have a negative pregnancy test 7 days before starting this treatment.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How is romidepsin given?

Romidepsin is injected into a vein by a healthcare provider.

This medicine must be given slowly over 4 hours.

Romidepsin is given in a 28-day treatment cycle. You will receive an injection only on certain days of this cycle.

You may be given other medicine to prevent nausea or vomiting while you are receiving romidepsin.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests. Your heart function may also need to be checked

If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving romidepsin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of romidepsin?

• fever, flu symptoms, muscle aches;
• worsening skin symptoms;
• burning when you urinate; or
• cough, chest discomfort, feeling short of breath.

• chest pain, feeling short of breath;
• fast or pounding heartbeats, fluttering in your chest, sudden dizziness (like you might pass out);
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of tumor cell breakdown --tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

• low blood cells counts, infections;
• nausea, vomiting, loss of appetite;
• constipation;
• itching;
• tiredness; or
• changes in your sense of taste.

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.

What other drugs will affect romidepsin?

Tell your doctor about all your current medicines. Many drugs can affect romidepsin, especially:

• dexamethasone or other steroid medicine;
• St. John's wort;
• an antibiotic or antifungal medicine;
• an antidepressant;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart rhythm medicine;
• HIV or AIDS medicine;
• seizure medicine; or
• tuberculosis medicine.

This list is not complete and many other drugs may affect romidepsin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor can provide more information about romidepsin.