Biovinate Dosage/Direction for Use

General Dosing Information: Aluminum reacts with carboplatin. DO NOT use needles or IV sets containing aluminum parts that may come in contact with the drug in the preparation or administration of carboplatin. (see Interactions).
Carboplatin should be used by intravenous route only.
No pre- or post-treatment hydration or diuresis is necessary when carboplatin is administered.
Treatment should generally not be repeated until 4 weeks after the previous carboplatin course and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.
Initial dosage should be reduced by 20-25% in patients with risk factors such as previous myelosuppressive therapy and/or poor performance status (ECOG-Zubroid 2-4 or Karnofsky below 80).
Dosage must be based on the clinical, renal and hematologic response and tolerance of the patient in order to obtain optimum therapeutic outcome with minimum adverse effects.
As Monotherapy: The recommended initial dose of carboplatin for previously untreated patients with normal renal function is 400 mg/m², given as a single IV infusion over 15 to 60 minutes every 4 weeks (see Formula Dosing).
An initial dose of 360 mg/m² IV carboplatin once every 4 weeks (or longer if delayed for hematologic toxicity) can be used for the treatment of recurrent ovarian cancer.
Determination of the hematologic nadir by weekly blood counts during the initial courses of carboplatin treatment is recommended for subsequent courses of therapy (see Dosage Adjustment as follows).
In Combination with Cyclophosphamide: An initial dose of 300 mg/m² IV carboplatin can be used in adults for the treatment of advanced ovarian cancer (stage III and IV) in combination with cyclophosphamide. The subsequent dosage of the drug should be adjusted according to the patient's hematologic tolerance of the previous dose. Do not administer the next dose until the patient's hematologic function is within acceptable limits (For cyclophosphamide dosage adjustments, see product's labeling information).
In Other Combination Regimens: Clinicians should consult published protocols for the dosage of each chemotherapeutic agent and the method and sequence of administration when carboplatin is used as a component of a multiple-drug regimen.
Formula Dosing: Carboplatin's initial dose may be calculated by using a mathematical formula based on the patient's renal function and desired platelet nadir. The use of Calvert's formula, as compared to empirical dose calculation based on body surface area allows adjustment for patient variation in pretreatment renal function.
The formula is based on glomerular filtration rate (GFR in mL/min) and carboplatin AUC (in mg/mL·min). The total dose is calculated in mg, not in mg/m².
Total Dose (mg) = target AUC x (GFR + 25)
Target AUCs providing the most appropriate dosage range are based on the treatment status of the patient: See Table 1.

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Subsequent carboplatin dose should be adjusted according to hematologic tolerance to the previous dose (see Dosage Adjustments as follows).
The Calvert formula should not be used to determine carboplatin dosage for children or for adults with severe renal impairment (i.e., GFR <20 mL/min) since it is not sufficiently accurate.
Dosage Adjustments: Pretreatment platelet count and performance status are important prognostic factors for severity of myelosuppression in previously treated patients.
No specific dosage adjustment data for children has been calculated.
Subsequent doses of carboplatin in single or combination therapy should be based on the hematologic response of the patient. (See Table 2.)

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Geriatric Dosing: Because renal function is often reduced in geriatric patients, dosing formulas incorporating estimates of GFR should be used to provide predictable plasma carboplatin AUCs and minimize the risk of toxicity.
Dose in Patients with Renal Impairment: Patients with impaired renal function or creatinine clearances of <60 mL/min are at an increased risk of myelosuppression during carboplatin therapy that dosage in such patients should be adjusted according to the degree of renal impairment. The initial dose of carboplatin may be based on the following creatinine clearance: See Table 3.

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Subsequent dosage should be adjusted according to the patient's tolerance to the previous dose and acceptable level of myelosuppression.
Limited data are available for patients with creatinine clearance of <15 mL/min to permit dosage recommendations.