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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 300 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.
Pediatric Use: The safety and effectiveness of Nab-Paclitaxel in pediatric patients have not been evaluated.
Geriatric Use: Of the 229 patients in the randomized study who received Nab-Paclitaxel for the treatment of metastatic breast cancer, 13% were at least 65 years of age and < 2% were 75 years or older. No toxicities occurred notably more frequently among patients who received Nab-Paclitaxel.
A subsequent pooled analysis was conducted in 981 patients receiving Nab-Paclitaxel monotherapy for metastatic breast cancer, of which 15% were 65 years of age or older and 2% were 75 years of age or older. A higher incidence of epistaxis, diarrhea, dehydration, fatigue and peripheral edema was found in patients 65 years of age or older.
Of the 514 patients in the randomized study who received Nab-Paclitaxel and carboplatin for the first-line treatment of non-small cell lung cancer, 31% were 65 years or older and 3.5% were 75 years or older. Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years old. No overall difference in effectiveness, as measured by response rates, was observed between patients 65 years or older compared to patients younger than 65 years old.
Of the 431 patients in the randomized study who received Nab-Paclitaxel and gemcitabine for the first-line treatment of pancreatic adenocarcinoma, 41% were 65 years or older and 10% were 75 years or older. No overall differences in effectiveness were observed between patients who were 65 years of age or older and younger patients. Diarrhea, decreased appetite, dehydration and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old. Clinical studies of Nab-Paclitaxel did not include sufficient number of patients with pancreatic cancer who were 75 years and older to determine whether they respond differently from younger patients.
Patients With Hepatic Impairment: The exposure to paclitaxel may be higher in patients with hepatic impairment than in patients with normal hepatic function. Reduce Nab-Paclitaxel starting dose in patients with moderate to severe hepatic impairment. Do not administer Nab-Paclitaxel to patients with total bilirubin > 5 x ULN or AST> 10 x ULN. Do not administer to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment.
Patients With Renal Impairment: Adjustment of the starting Nab-Paclitaxel dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 30 to < 90 mL/min). There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance < 30 mL/min).
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