Oxaliplatin

When ATH:
L01XA03

Characteristic.

The powder is white or almost white. It comprises platinum, atom which is complexed with oxalate and 1,2-diaminocyclohexane.

Pharmacological action.
Antitumor, cytostatic, alkylating, immunosuppressive.

Application.

Metastatic colorectal cancer in combination with a fluoropyrimidine or possible combinations of them; ovarian cancer.

Contraindications.

Hypersensitivity (incl. to other drugs, containing platinum), pregnancy, lactation.

Restrictions apply.

Assessment of the risk-benefit ratio is needed in the appointment of the following cases: enable vetryanaya, herpes zoster, etc.. systemic infections, suppression of bone marrow function, prior cytotoxic or radiation therapy.

Pregnancy and breast-feeding.

Contraindicated in pregnancy.

Category actions result in FDA - D. (There is evidence of the risk of adverse effects of drugs on the human fetus, obtained in research or practice, However, the potential benefits, associated with drugs in pregnant, may justify its use, in spite of the possible risk, if the drug is needed in life-threatening situations or severe disease, when safer agents should not be used or are ineffective.)

At the time of treatment should stop breastfeeding.

Side effects.

From the digestive tract: loss of appetite, nausea, vomiting, gastrointestinal bleeding, diarrhea, abnormal liver function.

From the nervous system and sensory organs: generalized weakness, headache, dizziness, drowsiness, convulsions, peripheral sensory neuropathy (paresthesia of the upper and lower extremities), dysesthesia perioral area, upper respiratory tract and gastrointestinal tract, blurred vision.

Cardio-vascular system and blood (hematopoiesis, hemostasis): mielodeprescia (leukopenia, granulocytopenia, thrombocytopenia, anemia), bleeding and hemorrhage.

Other: hyperthermia, the development of infections, rash, flushing of the face, fibrosis, infiltration legkïx, sexual dysfunction, teratogenicity, embryotoxicity, allergic reactions, incl. anaphylactoid.

Cooperation.

Pharmaceutically compatible with aluminum salts (A precipitate formed and the effectiveness of). Incompatible with salt solutions (alkaline), containing chlorides, and etc. drugs to the same infusion system (especially 5-fluorouracil and folinic acid). Weakens the effectiveness of immunization inactivated vaccines; using vaccines, containing live viruses, enhances viral replication and side effects of vaccination. Potentsiruet neyrotoksicheskoe action etc.. antitumor agents, myelosuppression, induced myelotoxicity drugs and radiation therapy. Compatible in combination with other. anticancer drugs, including 5-fluorouracil (a synergistic cytotoxic effect).

Overdose.

Symptoms: increased side effects.

Treatment: simptomaticheskaya therapy; if necessary - transfusion of blood components, the appointment of broad-spectrum antibiotics; monitoring vital functions.

Dosing and Administration.

B /. When chemotherapy alone or combined: 130 mg / m² every 3 weeks in/in in the form of 2-6 h infusion in 250-500 ml 5% glucose solution — without spending additional hydration therapy. Dose picked individually, corrected based on the clinical effect and severity of neurologic. Decrease subsequent dose 25% in the following cases: paraesthesia, accompanied by pain, or functional impairment lasts longer than 7 days; paraesthesia, continuing until the next cycle of chemotherapy; IV degree of diarrhea (WHO classification), нейтропении III-IV степени (число нейтрофилов менее 1·10⁹/l), тромбоцитопении III-IV степени (число тромбоцитов менее 50·10⁹/l).

Precautions.

Use only under medical supervision, with experience chemotherapy. There must be adequate measures and tools for the diagnosis and treatment of possible complications, relief anaphylactoid reactions. Prior to and during treatment (at short intervals) you must determine the level of blood cells, conduct a full neurological examination. Число тромбоцитов перед последующим курсом должно быть более 50·10⁹/l, leukocytes 2 10⁹/l, A more pronounced suppression of bone marrow treatment should be discontinued until symptoms resolve gematotoksichnosti.

With the development of extravasation reactions (possible manifestation of blister agents) infusion should be discontinued immediately and symptomatic treatment start. Patients, in which during the infusion or within several hours after the 2-hour administration is observed perioral area development dysesthesia, upper respiratory tract and gastrointestinal tract, following the introduction of spend within 6 no. This condition is reversible (may increase in the cold), regress between courses of treatment, but takes a permanent nature with functional impairments when exceeding a total dose 800 mg / m² (6 rates). If painful paresthesia or functional impairment persist until the next cycle, treatment should be discontinued. Neurological disorders disappear more than 75% patients during the first months after the end of treatment.

In order to relief dyspepsia (nausea, vomiting) should be the appointment of antiemetics. In case of diarrhea need to increase fluid intake. In the event of thrombocytopenia advised extreme caution when performing invasive procedures, Regular inspection of places on / in the, skin and mucous membranes (for signs of bleeding), limit frequency troublesome and the rejection of the / m injection, control of blood in the urine, vomit, Kale. Such patients should be carefully shave, manicure, brush your teeth, dentists use threads and toothpicks, they need to carefully conduct dental procedures; should implement the prevention of constipation, avoid falls and other injuries, as well as the intake of alcohol and acetylsalicylic acid, increase the risk of gastrointestinal bleeding. It is necessary to avoid contact with infectious patients, or use non-event for the prevention of (face mask, etc.). During treatment, it is recommended to use adequate contraceptive measures. In case of contact with skin or mucous membranes must be thorough washing with water (mucosa) or soap and water (skin). Dissolution, dilution and administration of the preparation is carried out by trained medical staff with the protection (gloves, masks, clothing and other.). When used in combination with a fluoropyrimidine administered to them.

Cautions.

Do not use undiluted solution. The solution with no signs of precipitates usable and should be discarded. Infusion system after administration of oxaliplatin should be washed before using for the introduction of other drugs. The solution for the on / in the cook, adding to the vial with the contents of the solvent (water for injection or 5% glucose) to obtain the solution concentration 2,5 mg / ml or 5 mg / ml. Cooked solution can be stored 48 h at a temperature of +2 to +8 °C. To prepare the infusion solution dissolved diluted oxaliplatin 5% glucose solution to 250-500 ml (liquor stores 24 no).

Cooperation