BENDAMUSTINE- bendamustine hcl injection, powder, lyophilized, for solution BENDAMUSTINE- bendamustine hcl injection, powder, l

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

bendamustine hydrochloride (UNII: 981Y8SX18M) (bendamustine - UNII:9266D9P3PQ)

Pieejams no:

Meitheal Pharmaceuticals Inc.

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 i

Produktu pārskats:

Safe Handling and Disposal Bendamustine hydrochloride 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 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 as follows: Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Retain in original package until time of use to protect from light. Discard unused portion.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

BENDAMUSTINE- BENDAMUSTINE HCL INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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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 Injection) and a
lyophilized powder (Bendamustine 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
Bendamustine Hydrochloride for Injection: 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