Nab-Paxel

Metastatic Breast Cancer: After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for Nab-Paclitaxel is 260 mg/m² administered intravenously over 30 minutes every 3 weeks.

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.

The most common adverse reactions ( ≥20%) with single-agent use of Nab-Paclitaxel in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea.

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%).

There is no known antidote for Nab-Paclitaxel overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.

Nab-Paclitaxelis a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Cytotoxic Chemotherapy