HumanFeed & Digestive Products

Carboplatin

Composition

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.

Description

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.

Indications

Carboplatin injection is indicated for:

Initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents.

Palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin.

Treatment of small cell lung cancer.

Dosage & Administration

Administration: Usually administered by IV infusion lasting 15 minutes or longer. Pre- or post-treatment hydration or forced diuresis is not required.

Single-Agent Therapy: 360 mg/m² IV on day 1 every 4 weeks. Courses should not be repeated until neutrophil count is ≥2,000 and platelet count is ≥100,000.

Combination Therapy with Cyclophosphamide: Carboplatin 300 mg/m² IV on day 1 every 4 weeks for 6 cycles, with Cyclophosphamide 600 mg/m² IV on day 1 every 4 weeks for 6 cycles.

Dose Adjustment Recommendations:

<table>

<thead>

<tr><th>Platelets</th><th>Neutrophils</th><th>Adjusted Dose (From Prior Course)</th></tr>

</thead>

<tbody>

<tr><td>50–100,000</td><td>500–2,000</td><td>No Adjustment</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>

</tbody>

</table>

Calvert Formula for Dosing: Total Dose (mg) = (target AUC) × (GFR + 25).

Interaction

The renal effects of nephrotoxic compounds may be potentiated by Carboplatin.

Contraindications

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.

Side Effects

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.

Precautions & Warnings

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.