Carboplatin-Ebeve Conts. For Infusions 450mg 45ml
Indications for use:Cancer of the ovary, cervix, bladder, lung (small cell and non-small cell); metastatic carcinoma of the breast; malignant tumors of the head and neck, testicles (mono- and combination therapy).
Contraindications:- pronounced renal dysfunction;
- severe myelosuppression;
- heavy bleeding;
- pregnancy and lactation period;
- Hypersensitivity to carboplatin or other platinum-containing compounds.
Side effects:On the part of the hematopoietic system: the main toxic factor limiting the dose of carboplatin is the suppression of the function of bone marrow hematopoiesis. Myelosuppression is dose-dependent. The lowest level of platelets and leukocytes / granulocytes, as a rule, is achieved in 2-3 weeks after the start of taking the drug, while thrombocytopenia is more common. Adequate recovery to a level that allows the next dose of carboplatin to be taken usually takes at least 4 weeks. A sufficiently large number of patients may also show symptoms of anemia (hemoglobin level less than 11 g / dl), the intensity of which depends on the total dose of the drug. It may be necessary to conduct transfusion therapy, especially in patients undergoing long-term treatment (for example, more than 6 cycles of taking the drug). There is also a chance of clinical complications, such as fever, infectious diseases, sepsis / septic shock and bleeding.
On the part of the gastrointestinal tract: within 6-12 hours after taking the drug, there is a likelihood of nausea and / or vomiting (mild to moderate), lasting up to 24 hours or more. The risk of emetic effects can be reduced by pre-treatment with antiemetic agents, continuous intravenous infusion of carboplatin for 24 hours, or fractional dosing for 5 consecutive days. Other types of adverse effects on the gastrointestinal tract, such as inflammation of the oral mucosa, diarrhea, constipation and abdominal pain, have also been observed in some cases.
On the part of the central nervous system and peripheral nervous system: there is a likelihood of peripheral neuropathies, mainly in the form of paresthesia and reduction of deep tendon reflexes, which is more likely in patients over 65 years of age with prolonged or previous treatment with cisplatin. It is also possible the appearance of symptoms of dysfunction of the central nervous system. Prolonged drug therapy can lead to cumulative neurotoxicity.
On the part of the hearing: ototoxicity manifests itself in the form of tinnitus and impairment of hearing.
On the part of the organs of vision: there is a possibility of a temporary deterioration or complete loss of vision (loss of the ability to distinguish colors and see the light is possible), as well as other visual impairment. Improvement and / or full recovery of vision, as a rule, occurs within a few weeks after stopping the drug. In patients with impaired renal function, treated with high doses of carboplatin, cortical blindness was observed.
On the part of the kidneys: there may be a slight and temporary increase in serum creatinine and urea concentrations. Acute renal damage was rarely observed. The risk of nephrotoxicity with carboplatin intake (reduced creatinine clearance) increases with increasing doses of carboplatin, as well as in patients who have previously received treatment with cisplatin.
On the part of the liver: there may be a slight and, as a rule, a temporary increase in the concentrations of ACT, bilirubin and alkaline phosphatase in the blood serum. In patients treated with high doses of carboplatin with autologous bone marrow transplantation, significant impaired liver function was observed.
On the electrolyte balance side: hypokalemia, hypocalcemia, hyponatremia and / or hypomagnesiemia are possible.
Allergic reactions: erythematous rash, fever, pruritus, urticaria, bronchospasm, arterial hypotension and anaphylactic reactions. These reactions can occur within a few minutes after the introduction of carboplatin. In rare cases, exfoliative dermatitis may also occur.
Other side effects: alopecia, asthenia, flu-like symptoms, hemolytic-uremic syndrome, myalgia / arthralgia, heart failure, cerebrovascular disorders and allergic reactions directly at the injection site.
It is a pharmaceutical drug. Use only as directed by your doctor.
Mode of applicationCarboplatin can be used both as a monotherapy, and in combination with other anticancer drugs. The drug is introduced into / in the following dose regimens:
- 300 - 400 mg / m2 i / v drip for 15-60 minutes or as a 24-hour infusion;
- 100 mg / m2 IV drip for 15-60 minutes daily for 5 days.
The introduction of carboplatin is repeated at intervals of at least 4 weeks with platelet counts of at least 100,000 cells / mm3 of blood and neutrophils of at least 1,500 cells / mm3 of blood.
Fluid injection before or after the use of carboplatin, as well as forced diuresis is not required.
Depending on the state of the bone marrow or kidney function, the therapeutic dose of carboplatin can be corrected as follows:
- for patients who have symptoms of moderate or severe hematologic toxicity (ie, the number of platelets and neutrophilic leukocytes less than 50,000 and 500 / mm3, respectively), consider the possibility of reducing the dose - both in cases of monotherapy and in combined treatment regimens - by 25%;
- in patients with symptoms of impaired renal function (CC <60 ml / min), the risk of developing the toxic effects of carboplatin increases, therefore, the dose of carboplatin should be reduced as follows:
In a dry, dark place at a temperature of no higher than 25 ° C.