Romidepsin Injection

What is this medication?

ROMIDEPSIN (ROE mi DEP sin) treats lymphoma. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ISTODAX

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• High or low levels of electrolytes, such as magnesium or potassium in your blood
• Infection
• Irregular heartbeat or rhythm
• Liver disease
• Low blood cell levels
• An unusual reaction to romidepsin, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Pimozide
• Posaconazole
• Thioridazine

This medication may also interact with the following:

• Rifampin
• Warfarin

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work while taking this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Call your care team if you are around anyone with measles, chickenpox, or if you develop sores or blisters that do not heal properly.

If you have hepatitis B, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 1 month after stopping treatment. A negative pregnancy test is required before starting this medication. Estrogen and progestin hormones may not work as well while you are taking this medication. A barrier contraceptive, such as a condom or diaphragm, is recommended. Talk to your care team about other forms of contraception.

Use a condom during sex while taking this medication and for 1 month after the last dose. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

Do not breast-feed while taking this medication and for 1 week after stopping therapy.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in taste
• Constipation
• Fatigue
• Loss of appetite
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.