BENDAMUSTINE HYDROCHLORIDE injection, powder, lyophilized, for solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Eugia US LLC

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 regime n. Bendamustine hydrochloride 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 (see Data) . There are no available data on bendamustine hydrochlori

Dettagli prodotto:

Safe Handling and Disposal Bendamustine hydrochloride for injection, USP is a hazardous drug. Follow applicable special handling and disposal procedures1. 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 procedures¹. If a solution of bendamustine hydrochloride for injection, USP contacts the skin, wash the skin immediately and thoroughly with soap and water. If bendamustine hydrochloride for injection, USP 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  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. The vial stopper is not made with natural rubber latex.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BENDAMUSTINE HYDROCHLORIDE - BENDAMUSTINE HYDROCHLORIDE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
EUGIA US LLC
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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 for injection is available as a lyophilized
powder. (2)
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
25 mg or 100 mg lyophilized powder in a single-dose vial for
reconstitution. (3)
CONTRAINDICATIONS
Bendamustine hydrochloride 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 behavioral signs or symptoms suggestive of PML. (5.3)
Anaphylaxis and Infusion Reactions: Severe and anaphylactic reactions
have occurred; monitor clinical