Beleodaq

BELEODAQ- belinostat injection, powder, lyophilized, for solution
Spectrum Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Beleodaq is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14)]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

2 DOSAGE AND ADMINISTRATION

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 x 109 /L and the platelet count should be greater than or equal to 50 x 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 x 109 /L and/or recurrent platelet count nadirs less than 25 x 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

Dosage Modification

Dosage Modifications due to Hematologic Toxicities

Platelet count ≥ 25 x 109 /L and nadir ANC ≥ 0.5 x 109 /L

No Change

Nadir ANC < 0.5 x 109 /L (any platelet count)

Decrease dosage by 25% (750 mg/m2)

Platelet count < 25 x 109 /L (any nadir ANC)

Dosage Modifications due to Non-Hematologic Toxicities

Any CTCAE Grade 3 or 4 adverse reaction *

Decrease dosage by 25% (750 mg/m2)

Recurrence of CTCAE Grade 3 or 4 adverse reaction after two dosage reductions

Discontinue Beleodaq

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.

3 DOSAGE FORMS AND STRENGTHS

For injection: 500 mg, lyophilized powder in single-dose vial for reconstitution

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Hematologic Toxicity

Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary [see Dosage and Administration (2.2) and Adverse Reactions(6.1)].

5.2 Infections

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 [see Adverse Reactions (6.1)].

5.3 Hepatotoxicity

Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities [see Adverse Reactions (6.1)]. Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity[see Dosage and Administration (2.2)].

5.4 Tumor Lysis Syndrome

Tumor lysis syndrome has occurred in Beleodaq-treated patients in the clinical trial of patients with relapsed or refractory PTCL [see Clinical Studies (14)]. Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions [see Adverse Reactions (6.1)].

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