• Treatment of cutaneous T-cell lymphoma (CTCL) that has not responded to at least one prior systemic therapy.
• Treatment of peripheral T-cell lymphoma (PTCL) that has not responded to at least one prior therapy.

Contraindicated in:

• OB: Pregnancy (may cause fetal harm)
• Lactation: Avoid use.

Use Cautiously in:

• Congenital long QT syndrome, history of significant cardiovascular disease, concurrent antiarrhythmics or other medications that cause significant QT interval prolongation (↑ risk of arrhythmias)
• Electrolyte abnormalities (correct magnesium and potassium abnormalities prior to use)
• Moderate to severe hepatic impairment or end-stage renal disease
• Geri: May be more sensitive to drug effects
• Pedi: Safety and effectiveness not established.

CNS: fatigue.

CV: ECG changes, QT interval prolongation.

GI: anorexia, nausea, vomiting.

Hemat: ANEMIA, leukopenia, thrombocytopenia.

Misc: INFECTION (INCLUDING PNEUMONIA, SEPSIS, AND VIRAL REACTIVATION), tumor lysis syndrome.

Drug-Drug:

• May ↑ risk of bleeding withwarfarin or NSAIDs.
• May ↓ effectiveness of estrogen-containing contraceptives (competes with -estradiol for binding to estrogen receptors).
• Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and voriconazole may ↑ levels and risk of toxicity; avoid concurrent use.
• Rifampin may ↑ levels and risk of toxicity; avoid concurrent use.
• Strong CYP3A4 inducers, including dexamethasone, carbamazepine, phenytoin, rifabutin, rifapentine, and phenobarbital may ↓ levels and effectiveness; avoid concurrent use.
• Drugs that inhibit P-gp, including amiodarone, atorvastatin, cyclosporine, dipyridamole, ketoconazole, nelfinavir, quinidine, quinine, reserpine, saquinavir, spironolactone, tacrolimus, and verapamil may ↑ levels and the risk of toxicity; use cautiously.

• Lyophilized powder for injection : 10 mg/vial (contains povidone; enclosed diluent contains propylene glycol and dehydrated alcohol);

• IV (Adults): 14 mg/m² on days 1, 8 and 15 of a 28-day cycle, cycle may be repeated every 28 days depending on benefit and patient tolerance; dose may be ↓ to 10 mg/m² if adverse reactions occur.

Istodax

• Acts as an inhibitor of histone deacetylase (HDAC). HDACs modulate gene expression and transcription factors. Inhibition results in cell cycle arrest and apoptosis.

• ↓extent and spread of CTCL.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Protein Binding: 92–94%.

Metabolism/Excretion: Extensively metabolized, mostly by the CYP3A4 enzyme system.

Half-life: 3 hr.

(response)

• Advise patient to read the Patient Information that comes with medication prior to each dose.
• Instruct patient to notify health care professional promptly if excessive nausea or vomiting, abnormal heartbeat, chest pain, shortness of breath, fever; sore throat; signs of infection (burning with urination, cough, flu like symptoms, muscle aches with or without chest pain, worsening skin problems); bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; ↑ fatigue occurs. Caution patient to avoid crowds and persons with known infections. Infection may occur during and for up to 30 days following therapy. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs, because these may precipitate gastric bleeding.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient that this medication may have teratogenic effects. Non-hormonal contraception should be used during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize the need for periodic lab tests to monitor for side effects.

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NDC Code^*

• 0069- PFIZER LABORATORIES DIV PFIZER INC
  • 0069-0983- Romidepsin
    • 0069-0983-01- 1 KIT in 1 CARTON (0069-0983-01) * 2 mL in 1 VIAL, GLASS (0069-0972-01) * 2 mL in 1 VIAL, GLASS (0069-0961-01)

• 0703- Teva Parenteral Medicines, Inc.
  • 0703-3125- Romidepsin
    • 0703-3125-08- 1 KIT in 1 CARTON (0703-3125-08) * 2 mL in 1 VIAL, GLASS * 2 mL in 1 VIAL, GLASS

• 59572- Celgene Corporation
  • 59572-984- ISTODAX
    • 59572-984-01- 1 KIT in 1 CARTON (59572-984-01) * 2.4 mL in 1 VIAL, GLASS (59572-973-02) * 2.2 mL in 1 VIAL, GLASS (59572-962-10)