Oxazer 2mg/ml vial. 100mg/50ml instructions for use
Dosage form
Concentrate for the preparation of solution for infusion.
Compound
1 ml contains:
Active substance:
Oxaliplatin 2 mg.
Excipient:
Water for injection up to 1.0 ml.
Description of the dosage form
Transparent colorless liquid
Pharmacokinetics
In vivo, oxaliplatin undergoes active biotransformation and is not detected in plasma by the end of a 2-hour administration at a dose of 85 mg/m2, while 15% of the administered platinum is in the blood, and the remaining 85% is quickly distributed throughout the tissues or excreted in the urine. Platinum binds to plasma albumin and is excreted in urine within the first 48 hours.
By the fifth day, about 54% of the total dose is found in the urine and less than 3% in the feces.
In renal failure, there is a significant decrease in oxaliplatin clearance from 17.6 ± 2.18 L/hour to 9.95 ± 1.91 L/hour. The effect of severe renal impairment on platinum clearance has not yet been studied.
Pharmacodynamics
Oxaliplatin is an antitumor drug belonging to the class of platinum derivatives, in which the platinum atom forms a complex with oxalate and 1,2‑diaminocyclohexane. Oxaliplatin exhibits a wide range of cytotoxic effects. It also exhibits activity in vitro and in vivo in various cisplatin-resistant tumor models. In combination with fluorouracil, a synergistic cytotoxic effect is observed.
Studying the mechanism of action of oxaliplatin confirms the hypothesis that biotransformed, aqueous derivatives of oxaliplatin, interacting with DNA by forming inter- and intrastrand bridges, suppress DNA synthesis, which leads to cytotoxicity and an antitumor effect.
Indications
- Adjuvant therapy for stage III colon cancer (stage C according to the Duke classification) after radical resection of the primary tumor, in combination with fluorouracil/calcium folinate.
- Metastatic colorectal cancer (in combination with fluorouracil/calcium folinate).
- Metastatic colorectal cancer (as first-line therapy in combination with fluorouracil/calcium folinate and bevacizumab).
- Ovarian cancer as a 2nd line of therapy.
Contraindications
- Hypersensitivity to oxaliplatin or other components of the drug, as well as other platinum derivatives.
- Myelosuppression (neutrophil count <2000/μL and/or platelet count <100,000/μL) before the start of the first course of treatment.
- Peripheral sensory neuropathy with functional impairment before the start of the first course of treatment.
- Pregnancy and breastfeeding period.
- Children under 18 years of age.
Carefully
In patients with severe renal impairment (creatinine clearance <30 ml/min); in patients with a history of prolongation of the QT interval or in patients with factors predisposing to prolongation of the QT interval; when used simultaneously with drugs that can cause the development of rhabdomyolysis.
Shelf life and storage conditions
The drug should be stored out of the reach of children and at a temperature not exceeding 25°C.
Do not freeze!
Do not use the drug after the expiration date indicated on the package.
Shelf life: 2 years.
Vacation category
On prescription.
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