BELINOSTAT

Other

Brand names: Beleodaq

Intravenous

Mechanism of Action

12.1 Mechanism of Action 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).

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hematologic Toxicity : Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities
1 ) Infection : Serious and fatal infections (e
2 Infections Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq
Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections [see Adverse Reactions ( 6

Known Side Effects

6 documented side effects by frequency

Nausea

>10%

Vomiting

1-10%

Shortness of Breath

1-10%

Fatigue

1-10%

Constipation

1-10%

Diarrhea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous