Cisplatin-TEVA (Valium for solution for injection)

Alkylating-type antineoplastic agent, derivative Pt. It inhibits the synthesis of DNA (It binds to DNA within the cells to form- and linking mezhspiralnyh, which modify DNA structure), which leads to a prolonged inhibition of nucleic acid synthesis and cell death. To a lesser extent inhibits protein synthesis and RNA. It does not have a phase specificity. Pt complexes with the cis-arrangement of the halogen atoms can form stable chelate complexes with the components of purine and pyrimidine nucleic acid molecules, forming a point O. Communication within a filament or filaments parallel double helix DNA. Contributes to the antitumor effect is partly the effect of immunosuppressive. The therapeutic effects persist for several days after administration.

Skin cancer, melanoma, head and neck cancer, esophageal carcinoma, malignant lung disease, stomach, colon, ovary, uterine body, cervix, tubal, the renal pelvis and ureter, Bladder, urethra, prostate, testicle, penis, uterine sarcoma, osteogenic and soft part sarcoma, sarkoma Juinga, sympathicoblastoma, retinoblastoma, lymphoma, horionepitelioma uterus, medulloblastoma, malignant thymoma, mesothelioma.

Hypersensitivity, pronounced suppression of bone marrow hematopoiesis, CRF, hearing loss, polyneuritis, pregnancy, lactation. Acute infectious viral disease (enable vetryanaya, incl. recently transferred or recent contact with a patient, herpes zoster), fungal or bacterial origin; hyperuricemia (incl. manifesting gout and / or urate nefrourolitiazom), nefrourolitiaz, suppression of bone marrow hematopoiesis (incl. Background prior to radiotherapy or chemotherapy).

From the urinary system: impairment of renal function (reduction in glomerular filtration rate, giperkreatininemiя), hyperuricemia (particularly at doses above 50 mg / m). From the side of hematopoiesis: leukopenia, thrombocytopenia (more pronounced at higher doses administered 50 mg / m; the smallest number of platelets and white blood cells is usually marked by 18-32 days after administration of the initial dose and returned to baseline by 39 days), anemia (decrease in Hb over 2 g%). From the water-electrolyte metabolism: hypomagnesemia and hypocalcemia (increased muscle excitability, muscle spasm, tremor, Carpio foot spasms and / or tetany), kaliopenia, giponatriemiya. From the digestive system: nausea, vomiting, decreased appetite, activity increase “Hepatic” transaminases and alkaline phosphatase. From the nervous system: dizziness, perifericheskaya neuropathy, myasthenic syndrome, convulsions (the manifestation of such reactions the drug should be discontinued). From the senses: ototoxicity (develops in 10-30% patients, basically when used in high doses – noise in ears, hearing loss, up to one- or bilateral hearing loss in the range of frequencies 4-8 th. Hz), blurred vision and color perception, optic neuritis. From the CCC: tachycardia. Allergic reactions: swelling of the face, skin rash (removed / in the introduction of epinephrine, Corticosteroids and / or antihistamines PM).

As monotherapy in children and adults can use the following dose and schedule of administration: 1) I /, 15-20 mg / m, from 1 by 5 every day 3-4 Sun; 2) I /, 50-120 mg / m, 1 once every 3-4 Sun; 3) I /, 50-100 mg / m, on 1 and 8 every day 3-4 Sun; 4) intrapleurally, 40-50 mg / m, after draining the pleural cavity; 5) when ovarian tumor – 50 mg / m, 1 once every 3 Sun; 6) bladder cancer as monotherapy – 50-70 mg / m 1 once every 3-4 Sun; 7) B / A – through the arterial catheter; while tumors of the head and neck – 30 mg, osteosarcoma – 120-150 mg. In combination with other. antitumor drugs: when testicular tumors – daily, 20 mg / m, 5 day with an interval of 3 Sun, Total 3 exchange rate. For the prevention of nausea and vomiting, metoclopramide is used, ondansetron, tropizetron. The dose should be reduced in patients with bone marrow function. Repeated courses of administration should be carried out only after normalization of blood (creatinine concentration in the serum – below 140 mmol / l, the concentration of urea – below 9 mmol / l, the number of platelets – more 100 thous. / ul, leukocytes – more 4 thous. / ul).

To reduce the risk of nephrotoxicity should be hydration to patients, during and after therapy (in / in infusion 2 l 5% dextrose 300-500 ml 0.9% NaCl solution for 2-4 no). Before therapy, and then before the administration of subsequent doses is necessary to monitor renal function (urea and serum creatinine, CC), electrolytes, erythrocyte count, leukocytes and platelets, liver function and neurological status. It is necessary to take into account the increased risk of anaphylactoid reactions in patients, have relatives with allergic diseases. Before and during treatment should also monitor the performance of the audiogram. In children, the risk of ototoxicity above, than in adults. Cisplatin, взаимодействуя с Al3 , It forms a black precipitate (needle, syringes, catheters and kits for the on / in the PM, containing Al3 , It should not be used for its administration). To reduce the risk of bacterial contamination is recommended dilution of the drug immediately before use and start introducing the mixture as soon as possible after its preparation. Infusion should be completed within 24 hours after preparation of the solution. Dilution should be carried out in a specially designed area (preferably in a laminar flow hood for use with cytotoxic substances). When working with cisplatin should wear protective gown, mask, gloves and eye protection. In case of accidental contact of the solution with the skin and mucous membranes, the affected area must be immediately thoroughly washed with soap and water. Pregnant women should not work with cisplatin.

Do not appoint simultaneously with PM, have ototoksicheskoe, nephrotoxic, neurotoxic effects (aminoglikozidy, cephalosporins, “loop” Diuretic). Mannitol reduces the excretion in the urine of cisplatin. Cisplatin is typically used in combination therapy with the following cytotoxic drugs: in the treatment of testicular cancer – vynblastyn, bleomycin, actinomycin; in the treatment of ovarian cancer – cyclophosphamide, doxorubicin, geksametilmelamin, ftoruracil; in the treatment of head and neck cancer – bleomycin, and methotrexate. The dose is determined by the applied chemotherapy program.