BENDAMUSTINE HYDROCHLORIDE injection, powder, lyophilized, for solution BENDAMUSTINE HYDROCHLORIDE injection, powder, lyophiliz

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Apotex Corp

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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 hydrochloride use

leaflet_short:

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. 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 prior to dilution, remove gloves and follow disposal procedures1 . If a solution of bendamustine hydrochloride for injection contacts the skin, wash the skin immediately and thoroughly with soap and water. If bendamustine hydrochloride for injection 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 should be stored at 20°C to 25°C (68°F to 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. 

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BENDAMUSTINE HYDROCHLORIDE- BENDAMUSTINE HYDROCHLORIDE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
APOTEX CORP
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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:
•
•
DOSAGE AND ADMINISTRATION
Bendamustine hydrochloride for injection is available in two
formulations, a solution (bendamustine
hydrochloride injection) and a lyophilized powder (bendamustine
hydrochloride for injection). (2.1)
For CLL:
•
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 and dose 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 clinically
and discontinue drug for severe reactions. Pre-medicate in subsequent
cycles for milder reactions. (5.4)
Tumor Lysis Syndrome: May lead to acute renal failure and death;
anticipate and use supportive
measures in patients at high risk.