<p><strong>Pediatric Use</strong>: The safety and effectiveness of Nab-Paclitaxel in pediatric patients have not been evaluated.<br />
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<strong>Geriatric Use</strong>: 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 &lt; 2% were 75 years or older. No toxicities occurred notably more frequently among patients who received Nab-Paclitaxel.<br />
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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&nbsp;epistaxis, diarrhea, dehydration, fatigue and peripheral edema was found in patients 65 years of age or older.<br />
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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,&nbsp;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.<br />
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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.<br />
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<strong>Patients With Hepatic Impairment</strong>: The exposure to paclitaxel may be higher in patients with hepatic impairment than in patients with normal hepatic function. Reduce &nbsp;Nab-Paclitaxel starting dose in patients with moderate to severe hepatic impairment. Do not administer Nab-Paclitaxel to patients with total bilirubin &gt; 5 x ULN or AST&gt; 10 x ULN. Do not administer to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment.<br />
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<strong>Patients With Renal Impairment</strong>: Adjustment of the starting Nab-Paclitaxel dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance &ge; 30 to &lt; 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 &lt; 30 mL/min).</p>