BENDAMUSTINE HYDROCHLORIDE- bendamustine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE (UNII: 981Y8SX18M) (BENDAMUSTINE - UNII:9266D9P3PQ)

Available from:

Eagle Pharmaceuticals, Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bendamustine Hydrochloride Injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. Bendamustine Hydrochloride Injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine Hydrochloride Injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. [see Warnings and Precautions (5.3)] Pregnancy Category D [see Warnings and Precautions (5.9)] Risk Summary Bendamustine hydrochloride can cause fetal harm when administered to a pregnant woman. Bendamustine caused malformations in animals, when a single dose was administered to pregnant animals. Advise women to avoid becoming pregnant while receiving be

Product summary:

Bendamustine Hydrochloride Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1 . Care should be exercised in the handling and preparation of solutions prepared from Bendamustine Hydrochloride Injection. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If gloves come in contact with Bendamustine Hydrochloride Injection prior to dilution, remove gloves and follow disposal procedures1 . If a solution of Bendamustine Hydrochloride Injection contacts the skin, wash the skin immediately and thoroughly with soap and water. If Bendamustine Hydrochloride Injection contacts the mucous membranes, flush thoroughly with water. Bendamustine Hydrochloride Injection is supplied in individual cartons of 5 mL clear multiple-dose vials containing 100 mg of bendamustine hydrochloride as a clear, colorless to yellow ready-to-dilute solution. NDC 42367-520-25, 100 mg/4 mL (25 mg/mL). Store Bendamustine Hydrochloride Injection in refrigerator between 2° to 8°C (36° to 46°F). Retain in original carton until time of use to protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

BENDAMUSTINE HYDROCHLORIDE- BENDAMUSTINE HYDROCHLORIDE INJECTION
EAGLE PHARMACEUTICALS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENDAMUSTINE HYDROCHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BENDAMUSTINE HYDROCHLORIDE
INJECTION.
BENDAMUSTINE HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Bendamustine Hydrochloride Injection is an alkylating drug indicated
for treatment of patients with:
Chronic lymphocytic leukemia (CLL). Efficacy relative to first line
therapies other than chlorambucil has not been
established. (1.1)
Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during
or within six months of treatment with
rituximab or a rituximab-containing regimen. (1.2)
DOSAGE AND ADMINISTRATION
For CLL:
100 mg/m infused intravenously over 30 minutes on Days 1 and 2 of a
28-day cycle, up to 6 cycles. (2.1)
Dose modifications for hematologic toxicity: for Grade 3 or greater
toxicity, reduce dose to 50 mg/m on Days 1 and 2;
if Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m on Days
1 and 2. (2.1)
Dose modifications for non-hematologic toxicity: for clinically
significant Grade 3 or greater toxicity, reduce the dose to
50 mg/m on Days 1 and 2 of each cycle. (2.1)
Dose re-escalation may be considered. (2.1)
For NHL:
120 mg/m infused intravenously over 60 minutes on Days 1 and 2 of a
21-day cycle, up to 8 cycles. (2.2)
Dose modifications for hematologic toxicity: for Grade 4 toxicity,
reduce the dose to 90 mg/m on Days 1 and 2 of each
cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m on Days
1 and 2 of each cycle. (2.2)
Dose modifications for non-hematologic toxicity: for Grade 3 or
greater toxicity, reduce the dose to 90 mg/m on Days
1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce
the dose to 60 mg/m on Days 1 and 2 of each cycle.
(2.2)
General Dosing Considerations:
Delay treatment for Grade 4 hematologic to