BELEODAQ Powder for solution for injection Ref.[9943] Active ingredients: Belinostat

2.1 Dosing Information

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.

2.2 Dosage Modification for Hematologic and Non-Hematologic Toxicities

Table 1 displays the recommended Beleodaq dosage modifications for hematologic and non-hematologic toxicities. Base dosage adjustments for thrombocytopenia and neutropenia on platelet and absolute neutrophil nadir (lowest value) counts in the preceding cycle of therapy.

• Absolute neutrophil count (ANC) should be greater than or equal to 1.0 × 10⁹/L and the platelet count should be greater than or equal to 50 × 10⁹/L prior to the start of each cycle and prior to resuming treatment following toxicity. Resume subsequent treatment with Beleodaq according to the guidelines described in Table 1 below. Discontinue Beleodaq in patients who have recurrent ANC nadirs less than 0.5 × 10⁹/L and/or recurrent platelet count nadirs less than 25 × 10⁹/L after two dosage reductions.
• Other toxicities must be NCI-CTCAE Grade 2 or less prior to re-treatment.

Monitor complete blood counts at baseline and weekly. Perform serum chemistry tests, including renal and hepatic functions prior to the start of the first dose of each cycle.

Table 1. Dosage Modifications for Hematologic and Non-Hematologic Toxicities:

* For nausea, vomiting, and diarrhea, only dose modify if the duration is greater than 7 days with supportive management

2.3 Patients with Reduced UGT1A1 Activity

Reduce the starting dose of Beleodaq to 750 mg/m² in patients known to be homozygous for the UGT1A1*28 allele [see Clinical Pharmacology (12.5)].

2.4 Preparation and Administration Precautions

As with other potentially cytotoxic anticancer agents, exercise care in the handling and preparation of solutions prepared with Beleodaq.

2.5 Reconstitution and Infusion Instructions

• Aseptically reconstitute each vial of Beleodaq by adding 9 mL of Sterile Water for injection, USP, into the Beleodaq vial with a suitable syringe to achieve a concentration of 50 mg of belinostat per mL. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted product may be stored for up to 12 hours at ambient temperature (15-25°C; 59-77°F).
• Aseptically withdraw the volume needed for the required dosage (based on the 50 mg/mL concentration and the patient’s BSA [m2]) and transfer to an infusion bag containing 250 mL of 0.9% Sodium Chloride injection. The infusion bag with drug solution may be stored at ambient room temperature (15-25°C; 59-77°F) for up to 36 hours including infusion time.
• Visually inspect the solution for particulate matter. Do not use if cloudiness or particulates are observed.
• Connect the infusion bag containing drug solution to an infusion set with a 0.22 µm in-line filter for administration.
• Infuse intravenously over 30 minutes. If infusion site pain or other symptoms potentially attributable to the infusion occur, the infusion time may be extended to 45 minutes.

No specific information is available on the treatment of overdosage of Beleodaq. 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 [see Clinical Pharmacology (12.3)].

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. [see USP Controlled Room Temperature].

Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures [see References (15)¹].