romidepsin

Pronunciation: ROE mi DEP sin

Brand: Istodax

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is romidepsin?

Romidepsin is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or peripheral 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 health care provider before receiving romidepsin?

You should not use romidepsin if you are allergic to it.

Tell your doctor if you have ever had:

  • heart problems, 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.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Romidepsin can harm an unborn baby or cause birth defects if the mother or father is using this medicine. Keep using birth control for at least 1 month after your last dose.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because romidepsin can harm an unborn baby.

You should not breast-feed while using romidepsin, and for at least 1 week after your last dose.

How is romidepsin given?

Romidepsin is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

Romidepsin is given in a 28-day treatment cycle. You may need to use the medicine only during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with this medicine.

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

Romidepsin affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Your heart function may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

If you've ever had hepatitis B, using romidepsin can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

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

What happens if I overdose?

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

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?

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

You may get infections more easily, even serious or fatal infections, during treatment and within 30 days afterward. 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
  • 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 platelets --easy bruising, unusual bleeding, purple or red spots under your skin;
  • low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • signs of tumor cell breakdown --confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • loss of appetite; or
  • tiredness.

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

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