Istodax

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

Istodax is used for:

Treating cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) in certain patients.

Istodax is a histone deacetylase (HDAC) inhibitor. It works by killing sensitive cancer cells.

Do NOT use Istodax if:

  • you are allergic to any ingredient in Istodax
  • you are taking nilotinib or rifampin

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Istodax:

Some medical conditions may interact with Istodax. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have abnormal potassium or magnesium levels in your blood
  • if you have a history of liver or kidney problems, or irregular heartbeat (eg, QT prolongation, congenital long QT syndrome) or other heart problems
  • if you have nausea, vomiting, or diarrhea
  • if you have had chemotherapy treatment in the past
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Istodax. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Istodax
  • Antiarrhythmics (eg, amiodarone, propafenone, quinidine), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, macrolide antibiotics (eg, erythromycin, clarithromycin), maprotiline, methadone, nilotinib, paliperidone, pentamidine, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), tacrolimus, terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), tyrosine kinase receptor inhibitors (eg, dasatinib, sunitinib), or ziprasidone because the risk of severe and possibly fatal irregular heartbeat may be increased
  • Azole antifungals (eg, ketoconazole, voriconazole), boceprevir, HIV protease inhibitors (eg, atazanavir), nefazodone, telaprevir, or telithromycin because they may increase the risk of Istodax's side effects
  • Carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort because they may decrease Istodax's effectiveness
  • Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Istodax

This may not be a complete list of all interactions that may occur. Ask your health care provider if Istodax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Istodax:

Use Istodax as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Istodax. Talk to your pharmacist if you have questions about this information.
  • Istodax is usually given as an injection at your doctor's office, hospital, or clinic.
  • Do not use Istodax if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If you miss a dose of Istodax, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Istodax.

Important safety information:

  • Nausea, vomiting, and loss of appetite are common with Istodax. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Istodax may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Istodax may lower the ability of your body to fight infection. Infections can occur during treatment and within 30 days after treatment has stopped. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • A serious and possibly fatal condition called tumor lysis syndrome (TLS) has occurred infrequently in certain patients taking Istodax. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
  • Diabetes patients - Istodax may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Istodax. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including complete blood cell counts, blood electrolyte levels, and electrocardiograms (ECGs), may be performed while you use Istodax. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Tell your doctor or dentist that you take Istodax before you receive any medical or dental care, emergency care, or surgery.
  • Istodax should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Istodax may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Istodax while you are pregnant. It is not known if Istodax is found in breast milk. Do not breast-feed while you use Istodax.

Possible side effects of Istodax:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; fatigue; headache; loss of appetite; nausea; stomach pain; taste changes; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, tenderness, swelling, or redness; chest pain; decreased urination; fainting; fast or irregular heartbeat; mental or mood changes; muscle weakness, cramps, or spasms; seizures; severe or persistent dizziness, nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet; swelling, soreness, or redness of the mouth or tongue; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; weakness; unusual drowsiness; confusion; rapid breathing; flushing; fruit-like breath odor); symptoms of infection (eg, fever, chills, cough, sore throat, increased or painful urination, increased pain or redness of injured or damaged skin); tremor; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Istodax:

Istodax is usually handled and stored by a health care provider. Keep Istodax out of the reach of children and away from pets.

General information:

  • If you have any questions about Istodax, please talk with your doctor, pharmacist, or other health care provider.
  • Istodax is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Istodax or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Istodax. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Istodax. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Istodax.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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