TREANDA- bendamustine hydrochloride injection, solution, concentrate TREANDA- bendamustine hydrochloride injection, powder, lyo

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cephalon, LLC

INN (שם בינלאומי):

BENDAMUSTINE HYDROCHLORIDE

הרכב:

BENDAMUSTINE HYDROCHLORIDE 45 mg in 0.5 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

TREANDA® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. TREANDA 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. TREANDA 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 in pregnant women to evaluate for a drug-associated risk of major birth defects, mis

leaflet_short:

Safe Handling and Disposal TREANDA (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 TREANDA Injection and TREANDA 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 TREANDA Injection prior to dilution, remove gloves and follow disposal procedures1 . If a solution of TREANDA (bendamustine hydrochloride) contacts the skin, wash the skin immediately and thoroughly with soap and water. If TREANDA (bendamustine hydrochloride) contacts the mucous membranes, flush thoroughly with water. How Supplied TREANDA (bendamustine hydrochloride) Injection is supplied as a 90 mg/mL clear colorless to yellow solution in individual cartons as follows: TREANDA (bendamustine hydrochloride) for Injection is supplied in individual cartons as follows: Storage TREANDA Injection (45 mg/0.5 mL or 180 mg/2 mL solution) Store TREANDA Injection in refrigerator 2°C to 8°C (36°F to 46°F).  Retain in original package until time of use to protect from light. TREANDA for Injection (25 mg/vial or 100 mg/vial lyophilized powder) TREANDA for Injection 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.

מצב אישור:

New Drug Application

מאפייני מוצר

TREANDA- BENDAMUSTINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE
TREANDA- BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
CEPHALON, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TREANDA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TREANDA.
TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, FOR INTRAVENOUS USE
TREANDA
(BENDAMUSTINE HYDROCHLORIDE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
TREANDA 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
TREANDA is available in two formulations, a solution (TREANDA
Injection) and a lyophilized powder
(TREANDA for Injection). (2.1)
DO NOT USE TREANDA INJECTION WITH DEVICES THAT CONTAIN POLYCARBONATE
OR ACRYLONITRILE-
BUTADIENE-STYRENE (ABS), INCLUDING MOST CLOSED SYSTEM TRANSFER DEVICES
(CSTDS). (2.1, 2.4)
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
Injection: 45 mg/0.5 mL or 180 mg/2 mL (90 mg/mL) in a single-dose
vial. (3)
For Injection: 25 mg or 100 mg lyophilized powder in a single-dose
vial for reconstitution. (3)
CONTRAINDICATIONS
TREANDA 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 i