ABRAXANE- paclitaxel injection, powder, lyophilized, for suspension

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

PACLITAXEL (UNII: P88XT4IS4D) (PACLITAXEL - UNII:P88XT4IS4D)

Disponível em:

Abraxis BioScience, LLC

DCI (Denominação Comum Internacional):

PACLITAXEL

Composição:

PACLITAXEL 100 mg in 20 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. ABRAXANE is contraindicated in patients with: Risk Summary Based on its mechanism of action and findings in animals, ABRAXANE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available human data on ABRAXANE use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of paclitaxel formul

Resumo do produto:

ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is a white to yellow, sterile lyophilized powder supplied as: NDC : 68817-134-50 100 mg of paclitaxel in a single-dose vial, individually packaged in a carton. Store the vials in original cartons at 20°C to 25°C (68°F to 77°F). Retain in the original package to protect from bright light. Abraxane is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Status de autorização:

New Drug Application

Características técnicas

ABRAXANE- PACLITAXEL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
ABRAXIS BIOSCIENCE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABRAXANE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABRAXANE.
ABRAXANE FOR INJECTABLE SUSPENSION (PACLITAXEL PROTEIN-BOUND PARTICLES
FOR INJECTABLE
SUSPENSION)
(ALBUMIN-BOUND), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
WARNING: SEVERE MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.7)
8/2020
Contraindications (4)
8/2020
Warnings and Precautions (5.1, 5.2)
8/2020
INDICATIONS AND USAGE
ABRAXANE is a microtubule inhibitor indicated for the treatment of:
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DOSAGE AND ADMINISTRATION
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DO NOT ADMINISTER ABRAXANE THERAPY TO PATIENTS WITH BASELINE
NEUTROPHIL COUNTS
OF LESS THAN 1,500 CELLS/MM . (4)
3
MONITOR FOR NEUTROPENIA, WHICH MAY BE SEVERE AND RESULT IN INFECTION
OR SEPSIS.
(5.1, 5.3)
PERFORM FREQUENT COMPLETE BLOOD CELL COUNTS ON ALL PATIENTS RECEIVING
ABRAXANE.
(5.1, 5.3)
Metastatic breast cancer, after failure of combination chemotherapy
for metastatic disease or relapse
within 6 months of adjuvant chemotherapy. Prior therapy should have
included an anthracycline
unless clinically contraindicated. (1.1)
Locally advanced or metastatic non-small cell lung cancer (NSCLC), as
first-line treatment in
combination with carboplatin, in patients who are not candidates for
curative surgery or radiation
therapy. (1.2)
Metastatic adenocarcinoma of the pancreas as first-line treatment, in
combination with gemcitabine.
(1.3)
DO NOT SUBSTITUTE ABRAXANE FOR OTHER PACLITAXEL PRODUCTS. (2.1)
Extravasation: Closely monitor the infusion site for extravasation and
infiltration. (2.1)
Metastatic Breast Cancer (MBC): Recommended dosage of ABRAXANE is 260
mg/m intravenously
over 30 minutes every 3 weeks. (2. 2)
2
Non-Small Cell Lung Cancer (NSCLC): Recommended dosage of ABRA