VIVIMUSTA- bendamustine hydrochloride injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Slayback Pharma LLC

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. VIVIMUSTA is indicated for the treatment of adult 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. VIVIMUSTA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol [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:

How Supplied VIVIMUSTA (bendamustine hydrochloride injection) is a sterile clear, colorless to yellow solution for intravenous use supplied in individual cartons of 5mL clear glass multiple-dose vials providing 100 mg bendamustine hydrochloride per 4 mL. 100 mg/4 mL (25 mg/mL)  NDC 71225-120-01 Safe Handling and Disposal VIVIMUSTA (bendamustine hydrochloride injection) is a hazardous drug. Follow applicable special handling and disposal procedures1 . Care should be exercised in the handling and preparation of solutions prepared from VIVIMUSTA. 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 VIVIMUSTA prior to dilution, remove gloves and follow disposal procedures. If a solution of VIVIMUSTA (bendamustine hydrochloride injection) contacts the skin, wash the skin immediately and thoroughly with soap and water. If VIVIMUSTA (bendamustine hydrochloride injection) contacts the mucous membranes, flush thoroughly with water. Storage Store VIVIMUSTA (bendamustine hydrochloride injection) refrigerated at 2°C to 8°C (36°F to 46°F). Retain in original carton until time of use to protect from light.

מצב אישור:

New Drug Application

מאפייני מוצר

VIVIMUSTA - BENDAMUSTINE HYDROCHLORIDE INJECTION
SLAYBACK PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIVIMUSTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIVIMUSTA.
VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE INJECTION), FOR INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
VIVIMUSTA 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) (1)
DOSAGE AND ADMINISTRATION
For CLL:
• 100 mg/m infused intravenously over 20 minutes on Days 1 and 2 of
a 28 day cycle, up to 6 cycles (2.1)
(2)
For NHL:
• 120 mg/m infused intravenously over 20 minutes on Days 1 and 2 of
a 21 day cycle, up to 8 cycles (2.2)
(2)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/4 mL (25 mg/mL) in a multiple-dose vial (3). (3)
CONTRAINDICATIONS
History of a hypersensitivity reaction to bendamustine, polyethylene
glycol 400, dehydrated alcohol, or
monothioglycerol. Reactions to bendamustine hydrochloride have
included anaphylaxis and anaphylactoid
reactions. (4, 5.4) (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) (5)
• Progressive multifocal leukoencephalopathy (PML): Monitor for new
or worsening neurological, cognitive
or behavioral signs or symptoms suggestive of PML. (5.3)
• Anaphylaxis and Infusion-Related Reactions: Severe 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