Istodax

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

What is Istodax?

Istodax blocks certain enzymes in the body and interferes with the growth of tumor cells.

Istodax is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or CTCL).

Istodax is usually given after other medications have been tried without successful treatment of symptoms.

Istodax may also be used for other purposes not listed in this medication guide.

Important information

Before you receive Istodax, tell your doctor if you have an electrolyte imbalance, a personal or family history of "Long QT syndrome," heart disease, kidney disease, or liver disease.

Do not receive Istodax if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Istodax.

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You will need regular medical tests to be sure Istodax is not causing harmful effects. Do not miss any follow-up visits to your doctor.

Call your doctor if you have a serious side effect while taling Istodax, such as severe nausea or vomiting, chest pain, fast or uneven heartbeats, feeling short of breath, fever, chills, flu symptoms, pale skin, easy bruising or bleeding, muscle cramps, confusion, pain or burning when you urinate, or worsening of your CTCL skin symptoms.

Before receiving Istodax

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive Istodax:

  • an electrolyte imbalance (such as high or low levels of potassium or magnesium in your blood);

  • a personal or family history of "Long QT syndrome";

  • heart disease;

  • kidney disease; or
  • liver disease.

FDA pregnancy category D. Istodax can cause harm to an unborn baby or cause birth defects. Before you receive Istodax, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Istodax. It is not known whether romidepsin passes into breast milk or if it could harm a nursing baby. Do not receive Istodax without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

How is Istodax given?

Istodax is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

Istodax 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 Istodax.

Istodax can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your heart rate may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a Istodax overdose are not known.

What should I avoid?

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

Istodax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Istodax: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • severe nausea or vomiting;

  • chest pain, fast or uneven heartbeats, feeling short of breath;

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • low magnesium (depression, muscle cramps, feeling tired or irritable, severe or ongoing diarrhea);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  • pain or burning when you urinate; or

  • worsening of CTCL skin symptoms.

Less serious Istodax side effects may include:

  • nausea, vomiting, loss of appetite;

  • diarrhea, constipation;

  • tired feeling; or

  • mild itching.

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 Istodax?

Many drugs can interact with Istodax. Below is just a partial list. Tell your doctor if you are using:

  • dexamethasone (Decadron, Hexadrol);

  • isoniazid (for treating tuberculosis);

  • St. John's wort;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (Ery-Tab, Erythrocin), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), telithromycin (Ketek);

  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend);

  • an antidepressant such as amitriptylline (Elavil, Vanatrip), nefazodone;

  • anti-malaria medication;

  • a barbiturate such as phenobarbital (Solfoton);

  • a blood thinner such as warfarin (Coumadin);

  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan);

  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), quinidine (Quinidex, Quin-Release Quin-G), and others;

  • HIV or AIDS medications such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);

  • medicines used to prevent organ transplant rejection;

  • medicine to prevent or treat nausea and vomiting, such as droperidol (Inapsine) or ondansetron (Zofran);

  • medicines to treat a psychiatric disorder, such as clozapine (FazaClo, Clozaril), haloperidol (Haldol), or pimozide (Orap);

  • migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig);

  • narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose); or

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.

There are many other medicines that can interact with Istodax. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Istodax.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 11/18/2009 1:36:23 PM.

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