Advanced ovarian carcinoma of epithelial origin

Active Ingredient: Carboplatin

Indication for Carboplatin

Population group: women, only adults (18 years old or older)

Carboplatin is indicated for the treatment of:

  • Advanced ovarian carcinoma of epithelial origin in:
    • first line therapy
    • second line therapy, after other treatments have failed.

For this indication, competent medicine agencies globally authorize below treatments:

200-400 mg/m² once every 21 days

Route of admnistration

Intravenous

Defined daily dose

200 - 400 mg per m² of body surface area (BSA)

Dosage regimen

From 200 To 400 mg per m² of body surface area (BSA) once every 21 day(s)

Detailed description

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 AUCPlanned chemotherapyPatient treatment status
5-7mg/ml .minsingle agent CarboplatinPreviously untreated
4-6 mg/ml .minsingle agent CarboplatinPreviously treated
4-6mg/ml .minCarboplatin plus cyclophosphamidePreviously 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.

Impaired renal function

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 ClearanceInitial Dose (Day 1)
41-59 ml/min250 mg/m² I.V.
16-40 ml/min200 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.

Combination Therapy

The optimal use of Carboplatin in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.

Elderly

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.

Active ingredient

Carboplatin

Carboplatin interferes with DNA intrastrand and interstrand crosslinks in cells exposed to the drug. DNA reactivity has been correlated with cytotoxicity.

Read more about Carboplatin

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