Istodax

Generic Name: romidepsin (ROE mi DEP sin)
Brand Name: Istodax

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 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.

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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.

FDA pregnancy category D. 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 medication 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).

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 (including urine, feces, vomit, semen, vaginal fluid). 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. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Romidepsin side effects

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

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;

  • signs of infection--fever, swollen gums, painful mouth sores, cold or flu symptoms, cough, muscle pain, feeling very tired; 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.

See also: Side effects (in more detail)

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 medication--itraconazole, ketoconazole, voriconazole;

  • an antidepressant--citalopram, nefazodone; seizure medicine--carbamazepine, phenobarbital, phenytoin;

  • heart rhythm medicine--amiodarone, disopyramide, dofetilide, flecainide, ibutilide, procainamide, quinidine, sotalol;

  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-02-25, 8:21:38 AM.

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