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Belinostat

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What is Belinostat?

  • Belinostat (Beleodaq) is a histone deacetylase inhibitor used to treat people with a type of cancer called peripheral T-cell Lymphoma (PTCL) that comes back or does not respond to cancer treatment.

What are the uses of this medicine?

  • This medicine is used for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

How does this medicine work?

  • Beleodaq is a histone deacetylase (HDAC) inhibitor.
  • HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins.
  • In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells.
  • Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells.
  • Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).

Who Should Not Use this medicine ?

  • This medicine have no usage limitations.

What drug interactions can this medicine cause?

  • Avoid concomitant administration of Beleodaq with strong inhibitors of UGT1A1.

Is this medicine FDA approved?

  • This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

  • The recommended dosage of Beleodaq is 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on Days 1-5 of a 21-day cycle.
  • Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.

Administration

  • Beleodaq will be given to you by intravenous (IV) injection into your vein, usually over 30 minutes.
  • Beleodaq is given one time a day on Days 1 through 5 of a 21-day cycle of treatment.
  • You should have regular blood tests before and during your treatment with Beleodaq.
  • Your doctor may change your dose of Beleodaq, change when you receive your treatment, or stop treatment if you have certain side effects while receiving Beleodaq.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As injection: 500 mg, lyophilized powder in single-dose vial for reconstitution

This medicine is available in fallowing brand namesː

  • Beleodaq

What side effects can this medication cause?

The most common side effects of this medicine include:

  • fatigue
  • fever
  • low red blood cell count

Beleodaq may cause serious side effects, including:

What special precautions should I follow?

  • Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary.
  • Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections.
  • Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity.
  • Tumor lysis syndrome has occurred in Beleodaq-treated patients. Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions.
  • Nausea, vomiting and diarrhea occur with Beleodaq and may require the use of antiemetic and antidiarrheal medications.
  • Beleodaq can cause fetal harm when administered to a pregnant woman. Advise males with female partners of reproductive potential to use effective contraception during treatment with Beleodaq and for 3 months after the last dose.


What to do in case of emergency/overdose?

  • No specific information is available on the treatment of overdosage of Beleodaq.

Management of overdosage:

  • There is no antidote for Beleodaq and it is not known if Beleodaq is dialyzable.
  • If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating physician.
  • The elimination half-life of belinostat is 1.1 hours.


Can this medicine be used in pregnancy?

  • There are no available data on Beleodaq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • No animal reproduction studies were conducted with Beleodaq.

Can this medicine be used in children?

  • The safety and effectiveness of Beleodaq in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

  • Active ingredient: belinostat
  • Inactive ingredients: L-Arginine

Who manufactures and distributes this medicine?

  • Manufactured for: Acrotech Biopharma LLC, East Windsor, NJ 08520

What should I know about storage and disposal of this medication?

  • Store Beleodaq (belinostat) for injection at room temperature 20°C to 25°C (68°F to 77°F).
  • Excursions are permitted between 15°C and 30°C (59°F and 86°F).
  • Retain in original package until use.
  • Beleodaq is a cytotoxic drug.
  • Follow special handling and disposal procedures

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