Carboplatin lyophilisate for the in/in solution vial 450mg №1

Mechanism of action

The antitumor agent of the alkylating action, contains platinum. The mechanism of action is associated with the formation of crosslinks between adjacent guanine base pairs in DNA, which leads to the suppression of nucleic acid biosynthesis and cell death.

Metabolized by hydrolysis to form active compounds that interact with DNA. Protein binding is very low. However, platinum formed from carboplatin irreversibly binds to plasma proteins and is slowly eliminated with a minimum half-life of 5 days.
The half-life of carboplatin is 1.1–2 hours in the initial phase, 2.6–5.9 hours in the final phase. It is eliminated by the kidneys - 71% for 24 hours with a CC of 60 ml / min or more.

Indications and usage

Ovarian cancer, germ cell tumors of the testicles and ovaries, seminoma, malignant melanoma, head and neck tumors; lung cancer, cervical cancer, bladder cancer; osteogenic sarcoma.

The dosage regimen is set individually, depending on the indications, the tolerability of carboplatin and the chosen scheme of cytotoxic therapy. Carboplatin is used only in /. The average dose for adults is 400 mg / m² within 15-60 minutesThe next dose is administered no earlier than 4 weeks. In the case of previous treatment with drugs that have a mielodepressive effect, the dose of carboplatin is reduced by 20-25%. When used in patients with impaired renal function, the dose is adjusted depending on the CC values.

Adverse reactions

Hemic and lymphatic: leukopenia, thrombocytopenia, anemia.
Gastrointestinal: nausea, vomiting, constipation or diarrhea, anorexia, abnormal liver function.
Nervous system: decreased hearing and vision acuity; peripheral polyneuropathy.
Allergic reactions: skin rash, urticaria; rarely - bronchospasm and hypotension.
From the reproductive system: azoospermia, amenorrhea.
Other: renal dysfunction, alopecia, fever, pain at the injection site.

Contraindications

Severe renal dysfunction, previous severe myelodepression, recent significant blood loss, increased sensitivity to preparations containing platinum.

Pregnancy and breastfeeding

Contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding.
Women of childbearing age receiving carboplatin therapy should use reliable contraceptive measures.
In experimental studies, it was found that carboplatin has a teratogenic and embryotoxic effect.

Carboplatin is used with caution in patients with chickenpox (including those who have recently been ill or after contact with patients), herpes zoster, other acute infectious diseases, hearing impairment, ascites or exudative pleurisy.
Caution should be exercised when using carboplatin in patients after a course of radiation therapy.
Carboplatin is used only under the supervision of a physician experienced in Chemotherapy. Before and during treatment, it is necessary to monitor kidney function, peripheral blood picture, neurological status, and audiometry. Changes in biochemical parameters are possible: an increase in the level of urea and creatinine in the blood serum, a decrease in the concentration of Magnesium, potassium, and Calcium.
Against the background of the use of carboplatin, it is not recommended to vaccinate patients or their families.
Carboplatin may be carcinogenic.
Carboplatin in the form of powder for injection and solution for injection is included in the list of vital and essential drugs.

Drug Interactions

With simultaneous use with drugs that have mielodepressive, nephrotoxic, neurotoxic or ototoxic effects, mutual enhancement of toxic effects is possible.