Active Ingredient: Carboplatin
Carboplatin is indicated for the treatment of small cell carcinoma of the lung.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
200 - 400 mg per m² of body surface area (BSA)
From 200 To 400 mg per m² of body surface area (BSA) once every 21 day(s)
Carboplatin should be used by the intravenous route only. The recommended dosage of Carboplatin in previously untreated adult patients with normal kidney function, i.e. creatinine clearance >60 ml/min is 400 mg/m² as a single short term IV dose administered by a 15 to 60 minutes infusion. Alternatively, the Calvert formula shown below may be used to determine dosage:
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
| Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25] | ||
|---|---|---|
| Target AUC | Planned chemotherapy | Patient treatment status |
| 5-7mg/ml .min | single agent Carboplatin | Previously untreated |
| 4-6 mg/ml .min | single agent Carboplatin | Previously treated |
| 4-6mg/ml .min | Carboplatin plus cyclophosphamide | Previously untreated |
Note: With the Calvert formula, the total dose of Carboplatin is calculated in mg, not mg/m².
Therapy should not be repeated until four 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-Zubrod 2-4 or Karnofsky below 80).
Determination of haematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin.
Needles or intravenous sets containing aluminium parts that may come in contact with carboplatin injection should not be used for preparation or administration. Aluminium reacts with carboplatin injection causing precipitate formation and/or loss of potency.
The safety measures for dangerous substances are to be complied with preparation and administration. Preparation must be carried out by personnel who have been trained in the safe use while wearing protective gloves, face mask and protective clothes.
In patients with impaired renal function, dosage of carboplatin should be reduced (refer to Calvert formula) and haematological nadirs and renal function monitored.
Patients with creatinine clearance below 60 ml/min are at increase risk of severe myelosuppression. The frequency of severe leukopenia, neutropenia, or thrombocytopenia has been maintained at about 25% with the following dosage recommendations:
| Baseline Creatinine Clearance | Initial Dose (Day 1) |
|---|---|
| 41-59 ml/min | 250 mg/m² I.V. |
| 16-40 ml/min | 200 mg/m² I.V. |
Insufficient data exist on the use of carboplatin injection in patients with creatinine of 15 ml/min or less to permit a recommendation for treatment.
All of the above dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient’s tolerance and to the acceptable level of myelosuppression.
The optimal use of Carboplatin in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.
In patients of more than 65 years of age, adjustment of the carboplatin dose to the general condition is necessary during the first and the subsequent therapeutic courses.
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