Nab Paclitor
Nab-Paclitaxel [Nanoparticle Albumin-Bound Paclitaxel] ·Eskayef Pharmaceuticals Ltd.·IV Infusion
Administration
Non-Small Cell Lung Cancer: The recommended dose of Nab-Paclitaxel is 100 mg/m² administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin on Day 1 of each 21 day cycle immediately after Nab-Paclitaxel.
Adenocarcinoma Of The Pancreas: The recommended dose of Nab-Paclitaxel is 125 mg/m² administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Administer gemcitabine immediately after Nab-Paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
Dosage In Patients With Hepatic Impairment: For patients with mild hepatic impairment (total bilirubin greater than ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN), no dose adjustments are required, regardless of indication.
Do not administer Nab-Paclitaxel to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. Do not administer Nab-Paclitaxel to patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN regardless of indication as these patients have not been studied.
Effects
The most common adverse reactions ( ≥20%) of Nab-Paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
The most common serious adverse reactions of Nab-Paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%).
The most common adverse reactions resulting in permanent discontinuation of Nab-Paclitaxel are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%).
The most common adverse reactions resulting in dose reduction of Nab-Paclitaxel are neutropenia (24%), thrombocytopenia (13%), and anemia (6%).
The most common adverse reactions leading to withholding or delay in Nab-Paclitaxel dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
Indications
Non-Small Cell Lung Cancer: Nab-Paclitaxel 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.
Adenocarcinoma Of The Pancreas: Nab-Paclitaxel is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Pharmacology
Therapeutic
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