Beleodaq (belinostat)

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Beleodaq (belinostat)

Belinostat is is a medication used for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).

How to buy Beleodaq (belinostat): You can order Beleodaq (belinostat) from TheSocialMedwork if the drug has not been approved or is not available in your country.
Oncology Lymphoma
Marketing Authorisation Holder Spectrum Pharmaceuticals, Inc.
Mode of Action HDAC inhibitor (chemotherapy)
Administration Intravenous
Regulatory agency approval Food and Drug Administration (FDA), USA
Strength 500 milligram
Package 1 vial of 30 ml - Vials

What is Beleodaq (belinostat) for?

Belinostat is a histone deacetylase (HDAC) inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), which shows preferential cytotoxicity towards tumour cells compared to normal cells1. Peripheral T-cell lymphoma are a group of T-cell lymphomas, blood cell tumours that affect T-cells, that develop away from the thymus.

How does Beleodaq (belinostat) work?

Several physiological and pathological cellular processes in the body are controlled by the balance between protein acetylation and deacetylation. Acetyltransferases (HATs) and deacetylases (HDACs) are enzymes involved in the maintenance of this equilibrium2. A dysregulation of the HAT-HDAC balance has been well established as a significant event in lymphoma genesis3. HATs are associated with gene transcription while HDAC activity is associated with gene silencing. Altered expression and mutations of genes that encode HDACs have been linked to tumour development since they induce the aberrant transcription of key genes regulating important cellular functions such as cell proliferation, cell-cycle regulation, and apoptosis4.

Where has Beleodaq (belinostat) been approved?

Belinostat was approved for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma by:

  • Food and Drug Administration (FDA), USA, July 3, 20141.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Beleodaq (belinostat) taken?

The standard dosage is:

  • 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on days 1 to 5 of a 21-day cycle.

Cycles can be repeated until disease progression or unacceptable toxicity.

Treatment discontinuation or interruption with or without dosage reductions by 25% may be needed to manage adverse reactions1.

Complete information about belinostat dosage and administration can be found in the prescribing information listed in the resources section1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Beleodaq (belinostat)?

Common side effects

The most common side effects (>25%) listed in the prescribing information include1:

  • nausea
  • fatigue
  • pyrexia
  • anemia
  • vomiting.

Thrombocytopenia was reported in 16% of patients with grade 3 or 4 thrombocytopenia in 7% of patients.

Serious side effects

Serious side effects were reported in 47% of patients. The serious adverse reactions (>2%) listed in the prescribing information include1:

  • pneumonia
  • pyrexia
  • infection
  • anemia
  • increased creatinine
  • thrombocytopenia
  • multi-organ failure
  • one treatment-related death due to hepatic failure was reported.

The European Medicines Agency (EMA) granted orphan designation for belinostat for the treatment of peripheral T-cell lymphoma6 and malignant thymoma7.

More Information
Working ingredient belinostat
Shipping method Controlled room temperature (temperature controlled)
Package 1 vial of 30 ml -
Therapeutic Area Oncology
Oncology Lymphoma
Indication Relapsed or refractory peripheral T-cell lymphoma (PTCL)
Administration Intravenous
Mode of Action HDAC inhibitor (chemotherapy)
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Spectrum Pharmaceuticals, Inc.
HS Code 29350090
CAS Number 414864-00-9

The efficacy of belinostat for relapsed or refractory peripheral T-cell lymphoma was investigated in a multi-centre, single-arm trial of 120 patients with refractory or relapsed PTCL. Belinostat was administered by intravenous infusion at a dose of 1,000 mg/m2 once daily on days 1–5 of a 21 day cycle.

Results

The overall response rate (ORR) was5,1:

  • 25.8% (95% CI: 18.3, 34.6)

    • Complete response rate: 10.8%.

The median response duration was1:

  • 8.4 months (95 % CI: 4.5, 29.4).

1. Summary of Product Characteristics [FDA]: Beleodaq (belinostat) [PDF]
    Spectrum Pharmaceuticals Inc., July 2014

2. Physical and Functional HAT/HDAC Interplay Regulates Protein Acetylation Balance
    J Biomed and Biotech, A. Peserico and C. Simone, 2011

3. Belinostat in patients with refractory or relapsed peripheral T-cell lymphoma: a perspective review.
    Ther Adv Hematol.  A. Sawas et al. Aug 2015

4. Histone deacetylase inhibitors and epigenetic regulation in lymphoid malignancies
    Invest New Drugs. D. Markozashvili et al, Dec 2015

5. FDA. Belinostat
    cited August 2016

6. EMA. Human Medicines: Rare diseases designation: EU/3/12/1055
    cited August 2016

7. EMA. Human Medicines: Rare diseases designation: EU/3/13/1351
    cited on August 2016


Shipping Type Cold Chain
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
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Questions our patients are asking

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By using TheSocialMedwork you will receive genuine medicines in perfect condition, no matter where you live.
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.