Romidepsin

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

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

Romidepsin may also be used for reasons not mentioned in this medication guide.

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.

Drink plenty of liquids in the 3 days after each injection.

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.

Use only as directed. Inform your doctor if you are taking other medicines or have any other medical conditions or allergies.

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.

Both men and women using romidepsin should use effective birth control to prevent pregnancy. Men should use condoms. Romidepsin can harm an unborn baby if the mother or father is using this medicine.

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

Romidepsin can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

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.

You should not breastfeed while using this medicine, and for at least 1 week after your last dose.

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

You may get infections more easily, even serious or fatal infections, during and after treatment. Call your doctor right away if you have signs of infection such as:

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

Also call your doctor at once if you have:

• 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 of romidepsin may include:

• low blood cell 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.

Usual Adult Dose for Cutaneous T-cell Lymphoma:

14 mg/m2 IV over 4 hours on days 1, 8, and 15 of a 28-day cycle; repeat cycle every 28 days provided patient continues to benefit and is tolerating therapy Uses: For the treatment of cutaneous T-cell Lymphoma (CTCL) in patients who have received at least 1 prior systemic therapy.

Call your doctor for instructions if you miss an appointment for your Romidepsin injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Romidepsin can lead to a serious heart issue. Your risk may increase if you also take certain other medications for infections, asthma, heart issues, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Inform your doctor about all the medications you are currently taking. Many drugs can impact romidepsin, especially:

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

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