belinostat

(redirected from Beleodaq)

belinostat

(be-lin-o-stat),

Beleodaq

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: temporary class
Pregnancy Category: D

Indications

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

Action

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.

Therapeutic effects

Decreased spread of relapsed/refractory PCTL.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Distributes into total body water, minimal tissue distribution; crosses the placenta.
Metabolism and 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.

Time/action profile (response)

ROUTEONSETPEAKDURATION
IVunknownunknown12 mo

Contraindications/Precautions

Contraindicated in: Concurrent use of strong inhibitors of UGT1A1; Obstetric: Pregnancy should be avoided (may cause fetal harm); Lactation: Breastfeeding should be avoided.
Use Cautiously in: Advanced stage disease/large tumor burden (↑ risk of Tumor Lysis Syndrome); genetic implication Patients with UGT1A1*28 polymorphism (initial dose reduction required); Moderate/severe hepatic impairment or CCr <39 mL/min; Obstetric: Women with child-bearing potential (reliable contraception recommended); Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue (most frequent)
  • dizziness
  • headache

Respiratory

  • cough

Cardiovascular

  • hypotension
  • peripheral edema
  • phlebitis

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • nausea (most frequent)
  • vomiting (most frequent)
  • abdominal pain
  • ↓ appetite
  • constipation
  • diarrhea

Genitourinary

  • ↑ creatinine

Dermatologic

  • pruritus
  • rash

Fluid and Electrolyte

  • hypokalemia

Hematologic

  • anemia (life-threatening)
  • leukopenia
  • thrombocytopenia (life-threatening)

Local

  • infusion site pain

Miscellaneous

  • infestion (life-threatening)
  • sepsis (life-threatening)
  • tumor lysis syndrome
  • chills (most frequent)
  • fever

Interactions

Drug-Drug interaction

Concurrent use of strong inhibitors of UGT1A1 including atazanvir, gemfibrozil, and indinavir may ↑ blood levels and risk of serious toxicity and should be avoided.

Route/Dosage

Intravenous (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.

Availability

Lyophilized powder for intravenous injection (requires reconstitution): 500 mg/vial

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of infections (fever, chills, dyspnea, cough). Do not administer belinostat in patients with active infections.
  • Assess for signs and symptoms of tumor lysis syndrome in patients with advanced stage disease and/or with high tumor burden.
  • Monitor for nausea, vomiting, and diarrhea. May require antiemetics and antidiarrheals.
  • Lab Test Considerations: May cause thrombocytopenia, leukopenia, and/or anemia. Monitor CBC at baseline and weekly during therapy. Absolute neutrophil count (ANC) should be ≥1.0 x 109/L and platelet count ≥50 x 109/L prior to each cycle and prior to resuming therapy following toxicity. Discontinue in patients who have recurrent ANC nadirs <0.5 c 109/L and/or recurrent platelet count nadirs <25 x 109/L after 2 dose reductions.
    • If platelet count ≥25 x 109/L and nadir ANC ≥0.5 x 109/L, continue therapy. If nadir ANC <0.5 x 109/L with any platelet count or platelet count <25 x 109/L with any nadir ANC, decrease dose by 25% to 750 mg/m2.
    • Other toxicities must be NCI-CTCAE Grade 2 or less prior to therapy. Any Grade 3 or 4 adverse reaction, decrease dose by 25%; if toxicity is nausea, vomiting, and diarrhea only decrease dose if duration is >7 days with supportive care.
    • May cause hepatotoxicity. Monitor liver function tests before therapy and at start of each cycle. Interrupt or adjust dose until recovery or permanently discontinue if severe.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)
Diarrhea (Adverse Reactions)

Implementation

  • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard IV equipment in specially designated containers (see ).
  • Intravenous Administration
  • Intermittent Infusion: Reconstitute each vial of belinostat by adding 9 mL Sterile Water for injection into vial for a concentration of 50 mg/mL. Swirl until no particles are visible. Reconstituted solution may be stored at room temperature for up to 12 hr. Diluent: Withdraw volume needed and inject into 250 mL of 0.9% NaCl. Diluted solution may be kept at room temperature for up to 36 hr. Do not use solutions that are cloudy or contain a precipitate. Infuse through a 0.22 micron in-line filter.
  • Rate: Infuse over 30 min. If infusion site pain or other infusion-related symptoms occur, extend infusion to 45 min.

Patient/Family Teaching

  • 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.
  • Advise patient that this medication may have teratogenic effects. Contraception should be used during therapy. Advise female patient to avoid breastfeeding.
  • Emphasize the need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

  • Decreased spread of relapsed/refractory of peripheral T-cell lymphoma.
References in periodicals archive ?
You also discover individual selling potentials of 15 emerging therapies, recently approved, including these agents: - Farydak - Ibrance - Lenvima - Opdivo - Unituxin - Beleodaq - Cyramza - Imbruvica.
Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).
Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous.
The safety and effectiveness of Beleodaq was evaluated in a clinical study involving 129 participants with relapsed or refractory PTCL.
Products discussed in this research report include Rituxan/Mabthera (rituximab) - Roche, Adcetris (Brentuximab vedotin) - Seattle Genetics/Millennium, Zevalin (ibritumomab tiuxetan) - Spectrum Pharmaceuticals, Revlimid (lenalidomide) - Celgene, Velcade (bortezomib) - Millennium/Johnson-Johnson, Istodax (romidepsin) - Celgene, Zolinza (vorinostat) - Merck, Zydelig (idelalisib/GS-1101) - Gilead Sciences, Imbruvica (ibrutinib) - Pharmacyclics/Janssen Biotech, Beleodaq (belinostat) - Spectrum Pharmaceuticals, Poteligeo (mogamulizumab) - Kyowa Hakko Kirin, Pixuvri (pixantrone dimaleate) - CTI BioPharma, Treanda (bendamustine) + Rituxan (rituximab), CHOP/R-CHOP and CVP/R-CVP.
Beleodaq -- Zykadia -- Cyramza -- Imbruvica -- Gazyva.
And you gain predictions for these expected treatments: -- Beleodaq -- Faridak
You also discover individual selling potentials of 23 rising and emerging therapies, including these: -- Beleodaq -- Zykadia -- Cyramza -- Imbruvica -- Gazyva.
There you see individual revenue forecasts to 2024 for these products: - Vidaza - Dacogen - Zolinza - Istodax And you gain predictions for these expected treatments: - Beleodaq - Faridak There you explore drugs and years with highest predicted sales.
The Company added that in this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity.
ALERT=zrmodule&ADID=ZACKS_PFP_TOP_ZRMODULE&skip_rpt_name_check=skip_rpt_name_check&t=SPPI) shares have been gaining ever since the FDA said that it will issue a response on the company's experimental lymphoma drug, Beleodaq, on a priority basis.