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Brand Names: Istodax

Generic Name: romidepsin (Pronunciation: ROE mi DEP sin)

• What is romidepsin (Istodax)?
• What are the possible side effects of romidepsin (Istodax)?
• What is the most important information I should know about romidepsin (Istodax)?
• What should I discuss with my health care provider before receiving romidepsin (Istodax)?
• How is romidepsin given (Istodax)?
• What happens if I miss a dose (Istodax)?
• What happens if I overdose (Istodax)?
• What should I avoid while receiving romidepsin (Istodax)?
• What other drugs will affect romidepsin (Istodax)?
• Where can I get more information?

What is romidepsin (Istodax)?

Romidepsin blocks certain enzymes in the body and interferes with the growth of tumor cells.

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

Romidepsin is usually given after other medications have been tried without successful treatment of symptoms.

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

What are the possible side effects of romidepsin (Istodax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe nausea or vomiting;
• chest pain, fast or uneven heartbeats, feeling short of breath;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• low magnesium (depression, muscle cramps, feeling tired or irritable, severe or ongoing diarrhea);
• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
• pain or burning when you urinate; or
• worsening of CTCL skin symptoms.

Less serious side effects may include:

• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• tired feeling; or
• mild itching.

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 is the most important information I should know about romidepsin (Istodax)?

Before you receive romidepsin, tell your doctor if you have an electrolyte imbalance, a personal or family history of "Long QT syndrome," heart disease, kidney disease, or liver disease.

Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking romidepsin.

You will need regular medical tests to be sure this medication is not causing harmful effects. Do not miss any follow-up visits to your doctor.

Call your doctor if you have a serious side effect such as severe nausea or vomiting, chest pain, fast or uneven heartbeats, feeling short of breath, fever, chills, flu symptoms, pale skin, easy bruising or bleeding, muscle cramps, confusion, pain or burning when you urinate, or worsening of your CTCL skin symptoms.

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