romidepsin

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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 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 medicines have been tried without successful treatment of symptoms.

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.

To make sure romidepsin is safe for you, tell your doctor if you have:

  • heart disease, heart rhythm disorder;
  • a personal or family history of long QT syndrome;
  • liver or kidney disease;
  • 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.

Do not use romidepsin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether romidepsin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is romidepsin given?

Romidepsin is injected into a vein through an IV. A healthcare provider will give you this injection. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

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

Romidepsin is usually given every 7 days for 3 weeks. This treatment cycle may be repeated 28 days after your first dose. Your doctor will determine how long to treat you with romidepsin.

Romidepsin can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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

If you have ever had hepatitis B, romidepsin can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

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 if you think you have used too much of this medicine.

What should I avoid while receiving romidepsin?

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

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.

Serious and sometimes fatal infections may occur during treatment and within 30 days after treatment with romidepsin. Call your doctor right away if you have signs of infection such as:

  • fever, chills, cold or flu symptoms,
  • rapid heart rate, rapid and shallow breathing, feeling like you might pass out;
  • stabbing chest pain, wheezing, cough with yellow or green mucus;
  • swollen gums, painful mouth sores, muscle pain, feeling very tired; or
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

  • worsening of CTCL skin symptoms;
  • pain or burning when you urinate;
  • chest pain, feeling short of breath;
  • low platelets --easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • low red blood cells --pale skin, feeling light-headed or short of breath, trouble concentrating;
  • signs of tumor cell breakdown --lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse; confusion, fainting; or
  • symptoms of a serious heart rhythm problem --headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats.

Common side effects may include:

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

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 medicines you use, and those you start or stop using during your treatment with romidepsin, especially:

  • dexamethasone;
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • St. John's wort;
  • an antibiotic --clarithromycin, telithromycin; antifungal medicine --itraconazole, ketoconazole, voriconazole;
  • an antidepressant --citalopram, nefazodone; seizure medicine --carbamazepine, phenobarbital, phenytoin;
  • heart rhythm medicine --amiodarone, disopyramide, dofetilide, flecainide, ibutilide, procainamide, quinidine, sotalol; or
  • HIV/AIDS medicine --atazanavir, delavirdine, indinavir, nelfinavir, ritonavir, saquinavir; medicine to treat tuberculosis- -isoniazid, rifampin.

This list is not complete. Other drugs may interact with romidepsin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about romidepsin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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