BENDAMUSTINE HYDROCHLORIDE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bendamustine hydrochloride for 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 for 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 for Injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [see Warnings and Precautions ( 5.4)] Risk Summary In animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth

Product summary:

Safe Handling and Disposal Bendamustine hydrochloride is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Care should be exercised in the handling and preparation of solutions prepared from Bendamustine hydrochloride for Injection, USP. 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 for Injection, USP prior to dilution, remove gloves and follow disposal procedures 1 . If a solution of bendamustine hydrochloride contacts the skin, wash the skin immediately and thoroughly with soap and water. If bendamustine hydrochloride contacts the mucous membranes, flush thoroughly with water. How Supplied Bendamustine hydrochloride for Injection, USP is supplied in individual cartons as follows: Storage Bendamustine hydrochloride for Injection, USP (25 mg/vial or 100 mg/vial lyophilized powder) Bendamustine hydrochloride for Injection, USP may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F) (see USP Controlled Room Temperature). Retain in original package until time of use to protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENDAMUSTINE HYDROCHLORIDE- BENDAMUSTINE HYDROCHLORIDE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
BLUEPOINT LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENDAMUSTINE
HYDROCHLORIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION.
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Bendamustine hydrochloride for 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
Bendamustine hydrochloride is available in two formulations, a
solution (Bendamustine Hydrochloride
Injection) and a lyophilized powder (Bendamustine Hydrochloride for
Injection). ( 2.1)
For CLL:
100 mg/m
infused intravenously over 30 minutes on Days 1 and 2 of a 28-day
cycle, up to 6 cycles (
2.2)
For NHL:
120 mg/m
infused intravenously over 60 minutes on Days 1 and 2 of a 21-day
cycle, up to 8 cycles (
2.3)
DOSAGE FORMS AND STRENGTHS
For Injection: 25 mg or 100 mg lyophilized powder in a single-dose
vial for reconstitution. ( 3)
CONTRAINDICATIONS
Bendamustine hydrochloride for Injection is contraindicated in
patients with a history of a hypersensitivity
reaction to bendamustine. Reactions have included anaphylaxis and
anaphylactoid reactions. ( 4, 5.4)
WARNINGS AND PRECAUTIONS
Myelosuppression: Delay or reduce dose and restart treatment based on
ANC and platelet count
recovery. ( 5.1)
Infections: Monitor for fever and other signs of infection or
reactivation of infections and treat promptly.
( 5.2)
Progressive multifocal leukoencephalopathy (PML): Monitor for new or
worsening neurological, cognitive
or behav