Cisplatin concentrate for the preparation of the solution for the infusion of 0.5 mg/ml 50ml

Pharmacology

Antitumor agent, contains platinum. The mechanism of action is similar to the action of alkylating drugs and consists in dysfunction of DNA strands and the formation of crosslinks between them.

Pharmacokinetics

Bad penetrates through the BBB. It is rapidly metabolized by non-enzymatic conversion to inactive metabolites. Binding to proteins (in the form of metabolites) is 90%.
The half-life in the initial phase is 25-49 min; in the final phase with normal excretory function of the kidneys - 58-73 h, with anuria - up to 240 h. Excreted by the kidneys, 27-43% after 5 days; platinum can be detected in tissues within 4 months after administration.

Indications

Germ cell tumors of the testicle or ovaries, ovarian cancer, cancer of the uterus, uterus neuroblastoma, retinoblastoma, soft tissue sarcoma, lymphoma, uterine chorionic carcinoma, medulloblastoma, skin cancer, melanoma, head and neck tumor, esophageal cancer, lung cancer, stomach cancer, colon cancer, malignant thymoma, mesothelioma.

Dosing regimen

The dosage regimen is set individually, depending on the indications, the patient's condition and the Chemotherapy regimen used.
With metastatic germ cell tumorsCisplatin administered at the rate of 15-20 mg / m2 1 time / day for 5 days in combination with bleomycin and etoposide (or vinblastine) every 3-4 weeks.
In ovarian cancer, the drug is administered at a dose of 50 mg / m2 once in combination with doxorubicin every 3 weeks. As monotherapyCisplatin used for ovarian cancer at a dose of 100 mg / m2 1 time in 4 weeks. In bladder cancer, the drug is usually used as a monotherapy at a dose of 50-70 mg / m2 every 3-4 weeks.
The maximum dose is 120 mg / m2 1 every 3-4 weeks as a continuous infusion for several days or for 1 day.
If necessary, you can enter intrapleurally (after draining the pleural cavity).

Adverse Effects

From the digestive tract: nausea, vomiting, stomatitis, anorexia.
On the part of the blood system: leukopenia, anemia, thrombocytopenia.
On the part of the central nervous system: convulsions, peripheral neuropathy, optic neuritis, color disorders, ototoxicity.
Metabolism: hyperuricemia, hypocalcemia, hypomagnesemia, syndrome of inadequate secretion of antidiuretic hormone.
Reproductive system: amenorrhea, azoospermia.
Since the cardiovascular system: tachycardia, arterial hypotension.
Allergic reactions: skin rash, angioedema, hoarseness.
Other: nephrotoxic effect.

Contraindications

Severe renal dysfunction, hearing impairment, polyneuritis, hematopoietic depression, pregnancy, hypersensitivity to the drug.

Pregnancy and lactation

The drug is contraindicated in pregnancy.If necessary, use during lactation should decide on the termination of breastfeeding.
Women of childbearing age should use reliable contraceptive methods during therapy.
In experimental studies established teratogenic and embryotoxic effect of Cisplatin.

Special notes

Do not recommend the use of the drug in patients with chickenpox (including recently transferred or after contact with the sick), with herpes zoster and other acute infectious diseases.
It is used with caution in patients with gout or nephrolithiasis (including history), as well as in patients who have previously received cytotoxic chemotherapy or radiation therapy.
Before starting and during the period of drug treatment, it is necessary to monitor the peripheral blood picture, laboratory data of the kidney and liver function, indicators of water-electrolyte metabolism and uric acid level, and audiometry and neurological examinations.
The first manifestations of the nephrotoxic effect of cisplatin occur on the 2nd week after administration and are manifested by increased levels of creatinine, uric acid, residual nitrogen and / or a decrease in CC. To reduce nephrotoxicity, it is recommended to administer a 0.9% sodium chloride or 5% glucose solution by intravenous infusion before the treatment and additionally prescribe mannitol.
Against the background of drug therapy, it is not recommended to vaccinate patients and their families.

Drug interactions

The simultaneous use of cisplatin with uricosuric anti-gout agents may increase the risk of nephropathy.
Combined use with antihistamines, phenothiazines, thioxanthenes can mask the symptoms of the ototoxic effect of cisplatin.
At simultaneous use with the drugs having an ototoksichesky, nephrotoxic, neurotoxic effect, strengthening of toxic effects is possible.

Storage conditions

List A. Store in a dark place at a temperature not exceeding +25 ° C in the reach of children. Do not freeze.