Carboplatin is an anticancer drug with alkylating, cytostatic and immunosuppressive effects.
Release form and composition
Carboplatin dosage form is a concentrate from which a solution is prepared for infusions (in 5, 15, and 45 ml dark glass bottles).
The active ingredient of the drug is carboplatin, in 1 ml of its concentrate contains 10 mg.
Indications for use
- Cancer of the cervix and body of the uterus;
- Ovarian cancer;
- Mammary cancer;
- Germ cell tumors of the testicle (including seminoma) and ovaries;
- Bladder cancer;
- Head and neck tumors;
- Lung cancer;
- Malignant melanoma;
- Osteogenic sarcoma.
- Severe renal dysfunction;
- Clinical signs of bleeding (including from tumor tissue) or recent significant blood loss;
- Prior expressed myelodepression;
- Lactation period;
- Hypersensitivity to carboplatin or other preparations containing platinum.
With caution and under special medical supervision, Carboplatin is used in the post-vaccination period, after radiation therapy or treatment with nephrotoxic drugs, as well as in exudative pleurisy, ascites, hearing impairment, bone marrow hematopoietic suppression (including during concomitant radiation or chemotherapy), and during violations of function kidney, acute infectious diseases of bacterial, fungal and viral nature (including shingles and chicken pox).
In extreme cases, after a balance of benefits and risks, the drug is prescribed for the elderly over the age of 65.
Dosing and Administration
Carboplatin is intended for in / in the introduction. The concentrate is diluted immediately before administration in a physiological solution of NaCl or 5% glucose solution to achieve a concentration of 1-0.5 mg / ml.
Doses are selected individually, taking into account the indications and the stage of the disease, as well as the scheme of antitumor therapy. During treatment, they can be adjusted depending on the clinical effect and the severity of toxic effects.
Carboplatin can be used as a single agent or in combination with other antitumor agents. Introduce it in / in drip, as a rule, in accordance with one of the schemes:
- At a dose of 300-400 mg / m 2 for 15-60 minutes or as a 24-hour infusion;
- At a dose of 100 mg / m 2 for 15–60 min daily for 5 days.
Repeated administration of the drug is carried out with a minimum interval of 4 weeks, provided that the platelet count is at least 100,000 cells / mm 3 of blood, and neutrophils - at least 1,500 cells / mm 3 of blood.
The therapeutic dose of carboplatin may be adjusted depending on the state of the bone marrow. It is reduced by 25% in patients who have symptoms of moderate or severe hematological toxicity (platelet count less than 50,000 / mm 3 , neutrophilic leukocytes less than 500 / mm 3 ).
For patients with impaired renal function, the dose is adjusted in accordance with creatinine clearance: with KK 41–59 ml / min - 250 mg / m 2 , with KK 16–40 ml / min - 200 mg / m 2 .
People over 65 years of age, as well as patients with risk factors (for example, if courses of myelosuppressive therapy were previously performed) are recommended to reduce the dose by 20-25%.
- Hematopoietic system: oppression of bone marrow hematopoiesis;
- The digestive system: nausea and vomiting, diarrhea or constipation, loss of appetite, stomatitis, abdominal pain, abnormal liver function (increased serum bilirubin concentration, aspartate aminotransferase activity and alkaline phosphatase);
- Nervous system: peripheral polyneuropathy (decrease in deep tendon reflexes, paresthesia), asthenia, tinnitus, hearing loss, decrease in visual acuity up to the loss of ability to distinguish colors or complete loss of vision (it improves or is fully restored, usually within a few weeks after the end of the course of treatment), there are cases of cortical blindness in patients with impaired renal function who received high doses of carboplatin; with prolonged use may develop cumulative neurotoxicity;
- Urinary system: an increase in the concentration of urea and creatinine in the blood serum (the risk of nephrotoxicity increases with increasing dose of the drug, as well as in patients who have previously received cisplatin therapy);
- The reproductive system: amenorrhea, azoospermia;
- Water-electrolyte balance: hypocalcemia, hypomagnesemia, hypokalemia, hyponatremia;
- Allergic reactions: fever, urticaria, erythematous rash, pruritus, bronchospasm, anaphylactoid reactions, decrease in blood pressure, reactions at the injection site; in rare cases, exfoliative dermatitis;
- Other: flu-like symptoms, alopecia, changes in taste, myalgia / arthralgia, cerebrovascular disorders, hemolytic-uremic syndrome, heart failure.
In case of an overdose of carboplatin, nausea and vomiting appear, bleeding develops, severe bone marrow depression and hepatotoxicity. Such patients are subject to urgent hospitalization. Treatment of symptomatic overdose under the control of vital functions. If necessary, prescribe broad-spectrum antibiotics, carry out the transfusion of blood components.
Carboplatin treatment is carried out only under the supervision of a specialist with experience in chemotherapy. Dissolution, dilution and administration of the drug can be carried out exclusively by trained medical personnel in compliance with protective measures (clothing, masks, gloves, etc.). Adequate measures should be taken to diagnose and treat possible complications, including means for stopping anaphylactic reactions (epinephrine, corticosteroids, oxygen, antihistamines, etc.).
Before starting a course of therapy and periodically during the use of the drug, it is necessary to monitor the picture of peripheral blood, kidney function and neurological status, as well as audiometry. It should be borne in mind that changes in biochemical parameters are possible: a decrease in the concentration of potassium, magnesium and calcium, an increase in the level of creatinine and urea in the blood serum.
Immediately notify the doctor if symptoms such as fever, chills, hoarseness or cough, pain in the side or lower back, difficulty or urination, hemorrhage or bleeding, blood in the urine or feces, black stools.
In the event of thrombocytopenia, extreme caution should be exercised when performing invasive procedures, regularly inspect places of intravenous administrations, skin and mucous membranes (to detect signs of bleeding in time), as well as limit the frequency of venipuncture, refuse intramuscular injections, monitor blood content in urine and feces and vomit. It is recommended that such patients brush their teeth with caution, use toothpicks and dental floss, do manicures, shave, etc., should be taken to prevent constipation, avoid injuries and falls, avoid taking acetylsalicylic acid and alcohol, because they increase the risk of gastrointestinal bleeding.
During the period of treatment, as well as within 3-12 months after its termination, it is not recommended to vaccinate the patients themselves and family members living with them. Contact with infectious patients should be excluded, or at least use non-specific measures to prevent infection (for example, a protective mask).
In experimental studies it was found that carboplatin has an embryotoxic and teratogenic effect, therefore women of childbearing age should apply reliable methods of contraception during treatment.
Carboplatin is pharmaceutically incompatible with aluminum salts.
With simultaneous use with aminoglycosides, proparolol, mutual enhancement of nephrotoxicity is noted. Also, carboplatin enhances the effects of other drugs that have neurotoxic, myelosuppressive, nephrotoxic and ototoxic effects.
With cisplatin, cross-resistance is observed: carboplatin increases the ototoxic and neurotoxic effects caused by it.
Radiation therapy and other myelotoxic drugs potentiate thrombocytopenia and neutropenia, resulting in increased bone marrow depression.
Terms and conditions of storage
Store at a temperature not exceeding 25 ºС in a place well protected from sunlight and out of reach of children.
Shelf life - 2 years.