Paraplatin Dosage/Direction for Use

Posology: PARAPLATIN should only be used by the intravenous (IV) route. The recommended dose of PARAPLATIN in previously untreated adult patients with normal renal function is 400 mg/m² as a single dose administered by slow IV infusion (15 to 60 minutes) (the Formula for Calculation of Carboplatin Dose as follows can be used as an alternative). PARAPLATIN SHOULD NOT BE ADMINISTERED BY RAPID IV INJECTION. Therapy should not be repeated again until four weeks have elapsed and/or until the neutrophil count is at least 2,000/mm³ and the platelet count is at least 100,000/mm³.
Reduction of the initial dosage by 20-25% is recommended for those patients who present with risk factors, such as prior myelosuppressive treatments or low performance status (ECOG-Zubrod 2-4 or Karnofsky below 80). At the beginning of treatment or in subsequent courses, a dosage adjustment may be required in patients aged 65 years or older, according to the physical status of the patient (see Precautions). Determination of the hematological nadir by weekly blood counts, during the initial courses of PARAPLATIN treatment, is recommended for future dosage adjustment (see Precautions).
Impaired Renal Function: Patients with creatinine clearance values below 60 mL/min are at increased risk of severe myelosuppression.
The onset of severe leukopenia, neutropenia or thrombocytopenia (incidence of about 25%) may be controlled using the following dosing schedule: 250 mg/m² IV on Day 1 in patients with creatinine clearance values of 41 to 59 mL/min at baseline; 200 mg/m² IV on Day 1 in patients with creatinine clearance values of 16 to 40 mL/min at baseline.
Insufficient data are available to determine the dosing schedule of PARAPLATIN in patients with creatinine clearance of 15 mL/min or less. The previously mentioned dosing recommendations apply to the initial course of PARAPLATIN treatment. Subsequent dosages should be adjusted according to the patient's tolerance and the desired myelosuppressive effect.
Combination Therapy: The optimal use of PARAPLATIN in combination with other myelosuppressive drugs requires dosage adjustments according to the polychemotherapy regimen adopted.
Pediatric Population: Insufficient data are available to allow dosing recommendations of PARAPLATIN in pediatric patients.
Formula for Calculation of Carboplatin Dose: Another approach for determining the initial dose of PARAPLATIN is the use of a mathematical formula based on a patient's renal function before starting chemotherapy with this drug. The use of this dosing formula, as compared to empirical dose calculation based on body surface area, allows adequate compensation for patient variations in pre-treatment renal function that might otherwise result in either underdosing (in patients with above average renal function) or overdosing (in the opposite case).
A simple formula for calculating the dose to be administered, based upon a patient's Glomerular Filtration Rate (GFR in mL/min) and PARAPLATIN target AUC (expressed in mg/mL/min), has been proposed by Calvert and is indicated as follows: Dose (mg): (target AUC) × (GFR + 25).
Note: With the Calvert formula, the total dose of PARAPLATIN is calculated in mg, not mg/m². (See table.)

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