• Treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL).

Contraindicated in:

• Concurrent use of strong inhibitors of UGT1A1
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Advanced stage disease/large tumor burden (↑ risk of tumor lysis syndrome)
• Patients with UGT1A1*28 polymorphism (initial dose ↓ required)
• Moderate/severe hepatic impairment or CCr <39 mL/min
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: hypotension, peripheral edema, phlebitis.

Derm: pruritus, rash.

F and E: hypokalemia.

GI: nausea, vomiting, ↓ appetite, abdominal pain, constipation, diarrhea, HEPATOTOXICITY.

GU: ↓ fertility (males), ↑ serum creatinine.

Hemat: leukopenia, ANEMIA, THROMBOCYTOPENIA.

Local: infusion site pain.

Neuro: fatigue, dizziness, headache.

Resp: cough.

Misc: chills, tumor lysis syndrome, fever, INFECTION.

Drug-Drug:

• Concurrent use of strong inhibitors of UGT1A1 including atazanvir and gemfibrozil may ↑ levels and risk of serious toxicity; avoid concurrent use.

• Lyophilized powder for injection: 500 mg/vial;

• IV (Adults): 1000 mg/m²/day on days 1–5 of a 21-day cycle. Cycle may be repeated until disease progression or unacceptable toxicity. Patients with UGT1A1*28 polymorphism: 750 mg/m² initial dose.

Beleodaq

• Acts as a histone deacetylase (HDAC) inhibitor, produces accumulation of acetylated histones and other proteins resulting in cell cycle arrest/apoptosis of cells; may have affinity for tumor cells.

• Decreased spread of relapsed/refractory PCTL.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: histone deacetylase inhibitors

Absorption: IV administration results in complete bioavailability.

Distribution: Distributes into total body water, minimal tissue distribution; crosses the placenta.

Metabolism/Excretion: Rapidly and extensively metabolized by the liver, primarily by the UGT1A1 enzyme system with minor metabolism by other systems, <2% excreted unchanged in urine.

Half-life: 1.1 hr.

(response)

• Instruct patient to read the Patient Information sheet prior to starting therapy and with each cycle in case of changes.
• Advise patient to notify health care professional if signs and symptoms of low platelet counts (unusual bleeding and bruising), low red blood cell count (weakness, tiredness, pale skin, dyspnea), infection (fever, flu-like symptoms, cough, shortness of breath, burning with urination, muscle aches, worsening skin problems), or liver problems (yellowing of skin and whites of eyes, dark urine, itching, pain in upper right stomach area).
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Rep: Advise females of reproductive potential to use effective contraception during and for 6 mos after last dose and to avoid breastfeeding during and for 2 wks after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mos after last dose. May impair male fertility.
• Emphasize the need for periodic lab tests to monitor for side effects.

be-LIN-o-stat

NDC Code^*

• 68152- Spectrum Pharmaceuticals, Inc.
  • 68152-108- Beleodaq
    • 68152-108-09- 1 VIAL, SINGLE-DOSE in 1 CARTON (68152-108-09) > 10 mL in 1 VIAL, SINGLE-DOSE

• 72893- Acrotech Biopharma LLC
  • 72893-002- Beleodaq
    • 72893-002-01- 1 VIAL in 1 CARTON (72893-002-01) > 10 mL in 1 VIAL