Index of drugs

Advanced ovarian cancer of epithelial origin, both as a first-line drug and when other medicines have failed. Small cell lung cancer.

1 ml concentrate for making sol. for infusion contains 10 mg of carboplatin.

An anti-cancer drug, a platinum derivative. It shows a comparable effect to the effect of Cisplatin in relation to a wide range of different types of cancer, regardless of their place of occurrence. Carboplatin, like Cisplatin, induces changes in the subhelial DNA conformation (the production of cross-links between the strands of two contiguous DNA molecules and within the same strand of DNA), which disturbs DNA synthesis. After intravenous administration, the blood levels change in two phases: the half-life in the initial phase is 90 minutes, in the second phase - about 6 hours. About 87% of plasma platinum is bound to proteins within 24 hours of dosing. Carboplatin is excreted primarily in the urine, with approximately 70% of the platinum administered being detected within 24 h. Most of the administered dose is eliminated within the first 6 hours.

Hypersensitivity to carboplatin or other platinum-containing preparations. Severe bone marrow suppression. Severe renal impairment (GFR ≤ 20 ml / min). Bleeding from neoplastic lesions. Hearing disorders. Pregnancy and breastfeeding.

The drug should only be used in specialized cancer departments; drug should be administered under the supervision of an experienced oncologist. Caution should be used in patients with renal impairment or concomitantly treated with nephrotoxic drugs due to the increased risk of carboplatin myelotoxicity in these patients. In typical cases, courses of carboplatin should be given no more than once a month. Treatment with carboplatin in combination with other myelosuppressant compounds should be carefully planned in terms of the amount of doses used and intervals between doses, so as to minimize additive effects. In patients with severe myelosupression, transfusion-assisting treatment may be necessary. The use of antiemetics prior to carboplatin administration reduces the incidence and severity of gastrointestinal side effects.

Carboplatin used during pregnancy can cause serious birth defects. The drug is contraindicated in pregnancy. Women of childbearing potential should use effective contraception during treatment with carboplatin. Men of childbearing potential should use effective contraception during and up to 6 months after treatment with carboplatin. Do not use the drug during breast-feeding. Treatment with carboplatin may cause irreversible infertility - the patient should be informed about the possibility of sperm preservation before starting treatment.

Very common: myelosuppression - a dose limiting factor (thrombocytopenia, with platelet count <50 x1 0⁹1/1 patients, usually between 14 and 21 days of therapy, normalization within 35 days from the beginning of treatment; leukopenia with nadir between day 14 and day 28 after drug administration and normalization within 42 days; neutropenia with granulocytes <1 x 10⁹ in about 1/5 of patients; anemia with Hb values ​​<11 g / dl in more than 2/3 of patients) - myelosuppression may be more severe and last longer in patients with impaired renal function, previously treated with longer courses of treatment, in poor general condition and aged> 65 years; nephrotoxicity (increased urea or creatinine in the blood, renal dysfunction defined as a decrease in creatinine clearance <60 ml / min), nausea without vomiting or vomiting, hearing loss in the high frequency range (1% of patients showed clinical signs in the form of tinnitus), changes in the results of liver function tests (increase in alkaline phosphatase, ALT and AST, increase in total bilirubin).Common: allergic reactions (erythematous rash, fever, pruritus), neurotoxicity (mainly paresthesia and weakening of deep tendon reflexes), dysgeusia, weakness, alopecia, fever and chills without symptoms of infection. Uncommon: infection, bleeding, decrease in electrolytes in the blood (sodium, Magnesium, potassium and calcium). Rare: blood deficiency in the blood, anaphylactic or anaphylactoid reactions (including angioneurotic edema, bronchospasm, urticaria, facial edema), transient visual disturbances, transient loss of vision, haemolytic-uremic syndrome. Carboplatin has not been studied for potential carcinogenic properties, however, in the case of compounds with a similar mechanism of action and mutagenicity, the carcinogenic properties of these compounds have been reported.

Intravenously, infusion. Adults: 400 mg / m² pc. Subsequent cycles of therapy can be repeated after a 4-week break and when the neutrophil count is at least 2,000 cells / mm³and the platelet count is at least 100,000 cells / mm³. In patients with risk factors, such as previously applied bone marrow suppression treatment and / or radiotherapy or poor general condition (2-4 according to ECOG-Zubrod or <80 according to Karnofsky patient status scale), the starting dose of the drug should be used 300-320 mg / m². During the initial treatment cycles, blood counts should be monitored weekly (define nadir hematological values) and, if necessary, modify the dosage in subsequent cycles. In renal failure, the dose of carboplatin decreases depending on the degree of failure. If the GFR ≤ 20 ml / min, carboplatin should be discontinued. The initial dose of carboplatin is calculated using the Calvert formula, based on the initial renal function assessment and the target AUC: Dose (mg) = target AUC (mg / ml) x [GFR (ml / min) +25]. Target AUC 5-7 mg / ml min, carboplatin monotherapy, patient not yet treated; target AUC 4-6 mg / ml min, carboplatin monotherapy, patient previously treated; target AUC 4-6 mg / ml min, carboplatin + cyclophosphamide, patient not yet treated. Based on the Calvert formula, the total dose of carboplatin is calculated in mg, not in mg / m². Specific dosage recommendations for children and adolescents can not be provided. For patients> 65 years of age, the dose of carboplatin may need to be adjusted depending on the patient's general state of health.
The preparation should be administered as an intravenous infusion lasting 15-60 minutes. The solution for infusion should be prepared by dilution in a 5% Glucose solution for injection to a minimum concentration of 0.4 μg / ml.