(trade name)


Therapeutic: antineoplastics
Pharmacologic: temporary class
Pregnancy Category: D


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


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.


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)

IVunknownunknown12 mo


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


  • cough


  • hypotension
  • peripheral edema
  • phlebitis


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


  • ↑ creatinine


  • pruritus
  • rash

Fluid and Electrolyte

  • hypokalemia


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


  • infusion site pain


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


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.


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.


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)


  • 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 ?
Drugs profiles discussed in this report includes AFM-13, alemtuzumab, alisertib, belinostat, copanlisib, darinaparsin, denileukin diftitox, forodesine hydrochloride, lenalidomide, masitinib, mogamulizumab, pralatrexate, romidepsin, ruxolitinib phosphate, selinexor, SH-7129, TGR-1202.
With $115 million of cash and investments and a projected operating cash burn of approximately $25 million, we believe that we are in an excellent position to advance our core products, belinostat and CR011-vcMMAE, toward registration development during 2008 and to fund operations into 2011," commented Timothy Shannon, MD, President and Chief Executive Officer of CuraGen.
Safety profile suggests belinostat is acceptable for patients with Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL), including difficult-to-treat patients with low platelet counts due to marrow involvement with their disease or poor marrow reserve.
Anders Vadsholt, Topotarget s CEO, also released a statement: The positioning of BioAlliance Pharma, their late stage assets and expertise makes BioAlliance Pharma a perfect fit as a company to merge with, allowing the acceleration of belinostat development in several new orphan oncology indications by leveraging on both team s synergistic expertise.
Belinostat, HDAC inhibitor for the treatment of cancer:
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced surpassing the primary endpoint in the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization of CDX-011 or any of our other drug candidates, including rindopepimut (CDX-110), CDX-1135 (formerly TP10), CDX-1401, CDX-1127, CDX-301, Belinostat and any future action we or the FDA (or any other regulator) might take with respect to regulatory approvals.
Singh was the Chief Operating Officer at Spectrum Pharmaceuticals, where he spearheaded numerous strategic and commercial transactions, including the in-licensing of Belinostat.
TopoTarget Successfully Buys Back Full Control of Belinostat, Consolidating the Global Rights for the Product
Three poster presentations for FOLOTYN[R] (pralatrexate injection) and four poster presentations for belinostat, a novel HDAC inhibitor
Shrotriya, MD, Chairman, CEO, and President of Spectrum, said, "Based on the clinical data, belinostat was shown to have an acceptable safety profile and clinical efficacy, with complete responses in heavily pretreated patients.