מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BENDAMUSTINE HYDROCHLORIDE (UNII: 981Y8SX18M) (BENDAMUSTINE - UNII:9266D9P3PQ)
Accord Healthcare, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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 for Injection 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
Safe Handling and Disposal Bendamustine hydrochloride is a hazardous drug. Follow applicable special handling and disposal procedures 1 . 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 procedures 1 . 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 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 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.
Abbreviated New Drug Application
BENDAMUSTINE HYDROCHLORIDE- BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ACCORD HEALTHCARE, INC. ---------- 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 Hydrochloride Injection) and a lyophilized powder (Bendamustine Hydrochloride 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 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 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 beha קרא את המסמך השלם