Oxaliplatin lifilizat powder 50 mg bottle №1

pharmachologic effect

pharmachologic effect - antitumor, cytostatic.

Dosage and administration

In / in, in the form of 2-6 h infusion. Hyperhydration with oxaliplatin is not required.

Applies only to adults.

The drug should be applied immediately after preparation of the solution.

When combined with 5-fluorouracil, an oxaliplatin infusion should precede the administration of 5-fluorouracil.

Adjuvant therapy for colorectal cancer - 85 mg / m² Once every 2 weeks for 12 cycles (6 months).

Disseminated colorectal cancer (treatment) - 85 mg / m² Once in 2 weeks as monotherapy or in combination with 5-fluorouracil.

Re-introduction of oxaliplatin produce only if the number of neutrophils exceeds 1.5 · 10⁹/ l and platelets - 50 · 10⁹/ l.

Recommendations for dose adjustment and regimen of oxaliplatin

The dose administered should be adjusted depending on the severity of toxicity.

With manifestations of hematological toxicity (the number of neutrophils is less than 1.5 · 10⁹/ l or platelets less than 50 · 10⁹/ l), the next course of therapy should be delayed until the hematological parameters are restored to acceptable values ​​(neutrophil count ≥1.5 · 10⁹/ l or platelet ≥50 · 10⁹/ l)Before treatment and before each next cycle, it is necessary to perform a complete blood count with the determination of the number of leukocytes and platelets.

With the development of diarrhea of ​​the 4th degree of toxicity (according to the WHO scale), neutropenia of the 3-4th degree (the number of neutrophils <1 · 10⁹/ l), thrombocytopenia of grade 3-4 (platelet count <50 · 10⁹/ l) the dose of oxaliplatin in subsequent injections should be reduced from 85 to 65 mg / m² in the treatment of disseminated colorectal cancer and up to 75 mg / m² with adjuvant therapy in combination with a necessary reduction in the dose of Fluorouracil.

In patients who develop acute laryngopharyngeal dysesthesia during an infusion or for several hours after a 2-hour infusion, subsequent oxaliplatin injections should be given as a 6-hour infusion.

If neurological symptoms occur (paresthesia, dysesthesia - manifestations of peripheral sensory neuropathy), a dose adjustment of oxaliplatin is recommended depending on the duration and severity of these symptoms:

- with neurological symptoms disturbing the patient for more than 7 days, the subsequent dose of oxaliplatin should be reduced from 85 to 65 mg / m² in the treatment of disseminated colorectal cancer and up to 75 mg / m² adjuvant treatment for colorectal cancer;

- in case of paresthesia without functional impairment that persists until the next cycle, the subsequent dose of oxaliplatin should be reduced from 85 to 65 mg / m² in the treatment of disseminated colorectal cancer and up to 75 mg / m² adjuvant therapy;

- while maintaining paresthesia with functional impairment, by the beginning of the next Chemotherapy cycle, oxaliplatin should be canceled;

- when reducing the severity of symptoms of neurotoxicity in the background of the cancellation of oxaliplatin, it is possible to consider the issue of resuming treatment.

With the development of stomatitis and / or mucositis of the 2nd and more degrees of toxicity, treatment with oxaliplatin should be suspended until they stop or reduce the manifestations of toxicity to 1 degree.

Data on the use of oxaliplatin in patients with severe renal dysfunction are not available. For patients with impaired renal function of moderate severity, the benefit / risk ratio should be weighed before using the drug, since data on the safety and tolerability of the drug in this comorbid pathology are limited. Therapy can be started with the recommended dose with careful monitoring of renal function. Dose adjustment should be carried out depending on the degree of toxicity. With a mild degree of renal dysfunction, oxaliplatin dose adjustment is not required.

In patients with mild or moderately impaired liver function, dosage change is not required. Data on the use of oxaliplatin in patients with severe liver failure are not available.

Elderly patients.The safety profile of oxaliplatin used in monotherapy or in combination with 5-fluorouracil in patients over 65 years of age is similar to the profile of patients younger than 65 years. Correction of the dosing regimen in elderly patients is not required.

When preparing and administering a solution of oxaliplatin, one should not use needles and other equipment containing aluminum.

To prepare the reconstituted solution, the oxaliplatin lyophilisate is dissolved in water for injection or in a 5% dextrose solution (10 ml of solvent is injected in a 50 mg solution, 30 ml of a solvent in a 100 mg bottle, and 30 ml of a solvent in a 150 mg bottle). with an oxaliplatin concentration of 5 mg / ml.

The resulting solution is immediately diluted with 250-500 ml of 5% dextrose solution. The concentration of the resulting solution oxaliplatin should be from 0.2 to 0.7 mg / ml; at the same time, 0.7 mg / ml is the highest concentration used in clinical practice at a dose of 85 mg / m²

To prepare a solution of the drug should be used only recommended solvents. Do not use the drug undiluted.

Do not use saline solutions (including 0.9% sodium chloride solution) to dissolve the drug or to prepare an infusion solution.

Do not mix in one container or one infusion system with other drugs (especially with fluorouracil, alkaline solutions, trometamol, and folinate Calcium preparations containing trometamol in its composition).

Oxaliplatin therapy can be carried out in combination with the infusion of calcium folinate, while the drugs should not be mixed in a single infusion container.

Calcium folinate should be diluted with 5% dextrose solution, and in no case should not use solutions containing sodium chloride or alkaline solutions.

The prepared solution of the drug should be transparent and not contain undissolved particles. Otherwise, the drug solution can not be used.

A solution of the drug is used immediately after preparation.

The finished solution is intended for single use only. Unused solution of the drug must be destroyed.

The drug should be administered through a central or peripheral catheter within 2-6 hours.

In case of extravasation, the drug should be immediately discontinued.

The materials used to prepare the solution and its introduction must be destroyed in accordance with the rules of use of cytotoxic drugs.

Reconstituted solution in the original vial: the reconstituted solution should be diluted immediately.

Solution for infusion: the solution, when diluted in 5% dextrose solution, remains chemically and physically stable for 12 hours at a temperature of (5 ± 3) ° C. From a microbiological point of view, the solution prepared for infusion should be used immediately.In the case when the solution is not used immediately after preparation, the storage time and storage conditions of the solution prior to its use are determined at the discretion of the user and should not exceed 24 hours at 2-8 ° C in controlled aseptic conditions.

On prescription.

Keep out of the reach of children.