Index of drugs

Advanced ovarian cancer of epithelial origin: first-line treatment or second-line treatment after failure of treatment with other drugs. Small cell lung cancer.

1 ml concentrate for solution for infusion contains 10 mg 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 structure of the DNA, which are analogous to the "DNA shortening effect". There is a linear relationship between the dose and concentration in the total and free, ultrapathin platinum blood. The AUC for total platinum also shows a linear relationship with dose when the creatinine clearance is ≥ 60 ml / min. After administration of carboplatin, the observed final T-values ​​were observed_0,5 in the elimination phase of free ultrapathat platinum and carboplatin, they are about 6 h and 1.5 h, respectively. During the initial phase, most of the ultra-platinum platinum is present as carboplatin. Final T_0,5 total platinum in the blood is 24 h. Most of the drug is excreted in the urine in the first 6 h.

Hypersensitivity to carboplatin or other platinum containing compounds. Severe myelosupression. Bleeding from tumors. Pre-existing severe renal impairment (CCr <30 ml / min). Breastfeeding period.

Carboplatin works by myelotoxicity, therefore the peripheral blood count should be monitored during and after treatment with carboplatin; It is recommended to check the number of blood cells at the beginning of treatment and once a week during treatment with carboplatin to evaluate nadir hematological to adjust the Next dose. Treatment with carboplatin in combination with other myelosuppressants should be carefully planned with regard to dosage and time to minimize additive effects. In patients with severe myelosupression, supportive blood transfusion treatment may be required. Myelosuppression may be more severe and last longer in patients who have been treated intensively, in poor general condition and aged> 65 years. In addition, myelosupression caused by carboplatin is closely related to the renal clearance of the drug, therefore the parameters of renal function should be carefully evaluated before and during treatment; in patients with impaired renal function or those receiving concomitant medications with potentially nephrotoxic effects, more severe and longer-lasting myelotoxicity is more likely. Under normal circumstances, carboplatin levels should not be repeated more frequently than every month. In addition, liver function tests and neurological assessment of the patient should be performed regularly. Premedication with antiemetics may reduce nausea and vomiting during treatment. Due to the risk of allergic reactions following administration of carboplatin, patients should be closely monitored and given appropriate supportive treatment; the incidence of allergic reactions may be higher in the case of previous exposure to the platinum-containing drug, however, allergic reactions have also been observed already after primary exposure to carboplatin. The safety and efficacy of carboplatin in children have not been proven.

If carboplatin is used during pregnancy, the patient should be informed about the potential risk to the fetus (risk of embryotoxic and teratogenic effects). Women who are pregnant or become pregnant during treatment should be provided with genetic consultation. Women of childbearing potential should use effective contraception during treatment. Breastfeeding must be discontinued if a woman is treated with carboplatin. Men treated with carboplatin should avoid conceiving a child during treatment and for 6 months after the end of therapy. Treatment with carboplatin may cause irreversible infertility - the patient should be informed about the possibility of semen cryopreservation before starting treatment.

Very common: myelosuppression - thrombocytopenia, leukopenia, neutropenia, anemia (usually reversible and not cumulative when carboplatin monotherapy and at the recommended dose and frequency of administration), nephrotoxicity (usually does not require preventive measures such as irrigation with large amounts of fluids or forced diuresis, however, there may be an increase in urea or creatinine in the blood), decrease in electrolytes (sodium, Magnesium, potassium and Calcium, no clinical symptoms), nausea, vomiting (also severe), painful gastrointestinal disturbances, subclinical hearing loss, covering high frequency (4000-8000 Hz) hearing loss, abnormal liver function tests (usually mild or moderate, more alkaline phosphatase than ALT, AspT or total bilirubin), hyperuricaemia, asthenia. Common: haemorrhagic complications (usually minor), renal dysfunction (CCr <60 ml / min), diarrhea, constipation, mucositis, mild hypersensitivity reactions (eg skin rash, urticaria, erythema, unspecified fever or pruritus), tinnitus, neurotoxicity (peripheral neuropathy, paresthesia and reduction of deep tendon reflexes, alopecia, fatigue, uncommon: secondary tumors (no causal relationship established), infectious complications, central nervous system symptoms (they often seem to be associated with concomitant treatment antiemetic), fever and chills without evidence of infection, injection site reactions (eg pain, erythema, edema, urticaria and necrosis) Rare: febrile neutropenia, hyponatremia, changes in taste, anorexia, anaphylaxis, anaphylactic shock, angioneurotic edema or reactions anaphylactoid (including bronchospasm, urticaria and edema) zy), transient visual disturbances, sometimes including transient loss of vision (usually in patients with renal dysfunction treated with high doses of carboplatin), severe hepatic failure, including acute hepatic necrosis (following administration of higher carboplatin doses than recommended), haemolytic-uremic syndrome. Very rare: acute promyelocytic leukemia (6 years after carboplatin monotherapy and prior radiotherapy). Isolated cases: life-threatening infections and bleeding, cardiovascular events, i.e. heart failure, embolism and cerebrovascular events, i.e. stroke (no causal relationship established), hypertension. Serious loss of hearing has been reported in pediatric patients when carboplatin doses higher than those recommended in combination with other ototoxic agents have been reported.

Intravenously. Adults: patients not yet treated, with normal renal function (CCr> 60 ml / min) - 400 mg / m² every 4 weeks. Calvert's formula may be an alternative method of dose determination: dose (mg) = target AUC (mg / ml x min) x [GFR ml / min + 25]. The target AUC is: in the case of carboplatin monotherapy in patients not yet treated - 5-7 mg / ml x min; in the case of carboplatin monotherapy in previously treated patients - 4-6 mg / ml x min; in the case of combination therapy with carboplatin and cyclophosphamide in patients not yet treated - 4-6 mg / ml x min. Based on the Calvert formula, the total dose of carboplatin is calculated in mg, not in mg / m². Calverta should not be used in previously intensively treated patients, i.e. if they received any of the following treatments: mitomycin C; nitrosoureas; combination treatment with doxorubicin, cyclophosphamide and cisplatin; combination therapy with five or more agents; radiotherapy ≥ 4,500 radów, focused in the field 20 x 20 cm or in more than one field. During the initial cycles of treatment with carboplatin, blood counts should be monitored weekly (define nadir hematological values) and, if necessary, modify the dosage in subsequent cycles. Treatment should not be repeated earlier than 4 weeks after the previous treatment cycle and (or) until the neutrophil count is at least 2,000 cells / mm³and the platelet count is at least 100,000 cells / mm³. It is recommended to reduce the initial dose by 20-25% in patients with risk factors such as previous treatment causing bone marrow suppression or poor performance status (score 2-4 according to the ECOG-Zubroda scale or <80 according to the Karnofsky scale).Treatment with carboplatin should be discontinued in the case of non-responders to treatment, disease progression and / or the occurrence of intolerable side effects. The optimal use of carboplatin in combination with other bone marrow suppressants requires dose adjustment, depending on the treatment and treatment regimen.Impaired renal function: dose reduction or discontinuation of treatment is required for moderate renal impairment (CCr 30-59 ml / min), both nadir hematological and renal function should be frequently monitored; carboplatin is contraindicated in patients with CCr <30 ml / min.Elderly patients: dosage adjustment at the beginning or later of treatment may be necessary depending on the patient's physical condition.Way of giving: administered as an intravenous infusion lasting 15-60 min. Do not use needles, syringes, intravenous catheters or kits containing aluminum for the preparation or administration of carboplatin, as it may come in contact with carboplatin and lead to the formation of precipitate and / or weakness of antitumor activity. Before infusion, the concentrate should be diluted with 5% Glucose solution to a concentration of 0.4-2 mg / ml or 0.9% NaCl solution to a concentration of 2 mg / ml.