Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
PACLITAXEL (UNII: P88XT4IS4D) (PACLITAXEL - UNII:P88XT4IS4D)
Abraxis BioScience, LLC
PACLITAXEL
PACLITAXEL 100 mg in 20 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
New Drug Application
ABRAXANE- PACLITAXEL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION ABRAXIS BIOSCIENCE, LLC ---------- 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._ • • • 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: • • • DOSAGE AND ADMINISTRATION • • • • • • • ® 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 Izlasiet visu dokumentu