Aricarb 150 Injection: Each vial contains Carboplatin USP 150 mg, as sterile preservative free 15 ml concentrated solution for IV Infusion.
Aricarb 450 Injection: Each vial contains Carboplatin USP 450 mg, as sterile preservative free 45 ml concentrated solution for IV Infusion.
Carboplatin produces interstrand DNA cross-links that cause changes in the conformation of the DNA and affect DNA replication. This DNA reactivity has been correlated with cytotoxicity. Carboplatin injection is indicated for the treatment of Ovarian Carcinoma and Small Cell Lung Cancer.
Carboplatin injection is indicated for:
Administration: Usually administered by IV infusion lasting 15 minutes or longer. Pre- or post-treatment hydration or forced diuresis is not required.
Dose Adjustment Recommendations:
<table>
<thead>
<tr><th>Platelets</th><th>Neutrophils</th><th>Adjusted Dose (From Prior Course)</th></tr>
</thead>
<tbody>
<tr><td>>100,000</td><td>>2,000</td><td>125%</td></tr>
<tr><td>50–100,000</td><td>500–2,000</td><td>No Adjustment</td></tr>
<tr><td><50,000</td><td><500</td><td>75%</td></tr>
</tbody>
</table>
Patients with Impaired Kidney Function:
<table>
<thead>
<tr><th>Baseline Creatinine Clearance</th><th>Recommended Dose on Day 1</th></tr>
</thead>
<tbody>
<tr><td>41–59 mL/min</td><td>250 mg/m²</td></tr>
<tr><td>16–40 mL/min</td><td>200 mg/m²</td></tr>
</tbody>
</table>
The renal effects of nephrotoxic compounds may be potentiated by Carboplatin.
Carboplatin injection is contraindicated in patients with a history of severe allergic reactions to any platinum containing compounds. Carboplatin should not be employed in patients with severe bone marrow depression or significant bleeding.
Hematologic:
Thrombocytopenia, Neutropenia, Leukopenia, Anemia, Infections, Bleeding.
Gastrointestinal:
Nausea, Vomiting. Neurologic: Peripheral neuropathies, Ototoxicity, Central neurotoxicity.
Renal:
Serum creatinine elevations, Blood urea elevations.
Hepatic:
Bilirubin elevations, SGOT elevations, Alkaline phosphatase elevations,
Electrolytes loss:
Loss of Sodium, Potassium, Calcium, Magnesium.
Other side effects:
Pain, Asthenia, Alopecia, Mucositis.
Pregnancy: Pregnancy category D.
Carboplatin has been shown to be embryotoxic and teratogenic in animal, can causes fetal harm when administered to a pregnant woman.
Nursing Mothers:
It is not known whether Carboplatin is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to Carboplatin treatment of the mother, it is recommended that breastfeeding be discontinued if the mother is treated with Carboplatin injection.
Pediatric use:
Safety and effectiveness in pediatric patients have not been established.
Geriatric use:
In terms of safety, elderly patients treated with Carboplatin are more likely to develop severe thrombocytopenia than younger patients. Clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. As renal function is often decreased in the elderly, renal function should be considered in the selection of Carboplatin dosage.
Store in a dry place at temperature below 25 C. Protect from light and do not refrigerate. Keep out of the reach of children.