Romidepsin Injection

WHY is this medicine prescribed?

Romidepsin injection is used to treat cutaneous T-cell lymphoma (CTCL; a group of cancers of the immune system that first appear as skin rashes) in people who have already been treated with at least one other medication. Romidepsin injection is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by slowing the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Romidepsin injection comes as a powder to be mixed with liquid to be injected intravenously (into a vein) over a 4-hour period by a doctor or nurse. It is usually given on days 1, 8, and 15 of a 28-day cycle for as long as your doctor recommends that you receive treatment.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects. Talk to your doctor about how you are feeling during your treatment with romidepsin injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving romidepsin injection,

• tell your doctor and pharmacist if you are allergic to romidepsin injection, any other medications, or any of the ingredients in romidepsin injection. Ask your pharmacist or check the patient information for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with romidepsin: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving romidepsin injection. Do not start this medication while receiving romidepsin injection without discussing with your healthcare provider.

• tell your doctor if you have nausea, vomiting, or diarrhea or any type of infection before you begin your treatment with romidepsin injection. Also tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), an irregular or fast heartbeat, too much or too little potassium or magnesium in your blood, hepatitis B (HBV; a virus that infects the liver and may cause severe liver damage or liver cancer), Epstein Barr virus (EBV; a herpes virus that causes infectious mononucleosis and is associated with certain cancers), seizures, liver, kidney, or heart disease, or any other medical condition.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. For females, your doctor will check to see if you are pregnant within 7 days before you begin your treatment. You should use birth control to prevent pregnancy during your treatment with romidepsin injection and for at least one month after your final dose. However, you should not use hormonal (estrogen) contraceptives (birth control pills, patches, rings, implants, or injections) because romidepsin injection may stop these medications from working as they should. If you are a male with a female partner who could become pregnant, be sure to use birth control during your treatment with romidepsin injection and for at least one month after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving romidepsin injection, call your doctor immediately. Romidepsin injection may harm the fetus. You should not breastfeed during your treatment with romidepsin injection and for at least 1 week after your final dose.

What SPECIAL DIETARY instructions should I follow?

Be sure to drink plenty of fluids for at least 3 days following each dose of romidepsin injection.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while receiving this medication.

What SIDE EFFECTS can this medicine cause?

Romidepsin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• mouth sores
• headache
• changed sense of taste
• loss of appetite
• itching

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• tiredness or weakness
• pale skin
• shortness of breath
• chest pain
• irregular heartbeat
• feeling dizzy or faint
• easy bruising or bleeding
• fever, cough, flu-like symptoms, muscle aches, burning on urination, worsening skin problems, and other signs of infection (may occur up to 30 days after your treatment)
• rash
• blistering or peeling skin
• swelling of the hands, feet, ankles, or lower legs

Romidepsin injection may cause fertility problems. Talk to your doctor about the risks of receiving this medication if you would like to have children.

Romidepsin injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to romidepsin injection.

Ask your pharmacist any questions you have about romidepsin injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.