Expiration date: 07/2026

Active substance: Oxaliplatin
How to take, course of administration and dosage
Intravenously in the form of 2-6 h infusion. Hyperhydration when applying oxaliplatin does not require.
It is used only in adults.
The drug should be used immediately after preparation of the solution. In combination with 5-fluorouracil, the oxaliplatin infusion must precede the administration of 5-fluorouracil.
Adjuvant therapy of colorectal cancer: 85 mg / m 1 every 2 weeks for 12 cycles (6 months).
Disseminated colorectal cancer: 85 mg / m2 1 every 2 weeks as monotherapy or in combination with 5-fluorouracil.
Repeated administration of oxaliplatin is produced only when the number of neutrophils is more than 1500/µl and platelets are more than 50,000/µl.
Recommendations for dose adjustment and administration of oxaliplatin.
In the case of hematological disorders (number of neutrophils <, 1500/µl and/or platelets <, 50000/µl), the appointment of the next course is postponed until the restoration of laboratory parameters.
With the development of diarrhea 4 degree of toxicity (on a scale of who), neutropenia 3-4 degree (the number of neutrophils <, 1000/MCL), thrombocytopenia 3-4 degree (the number of platelets of < 50000/µl) dose of oxaliplatin on subsequent introductions should be reduced from 85 mg/m2 to 65 mg/m2 in the treatment of metastatic colorectal cancer and up to 75 mg/m2 in adjuvant therapy in addition to the usual reduction in the dose of 5-fluorouracil in case their combined application.
Patients who during infusions or within a few hours after 2-hour infusion develops acute laryngeal paresthesia, the next infusion of oxaliplatin should be carried out within 6 hours.
Recommendations for adjusting the dose of oxaliplatin in the development of neurotoxicity:

• with symptoms of neurotoxicity causing pain, lasting more than 7 days, the subsequent dose of oxaliplatin should be reduced from 85 mg / m2 to 65 mg / m2 in the treatment of disseminated colorectal cancer and to 75 mg / m2 in adjuvant therapy,
• in paresthesia without functional disorders, persisting until the next cycle, the subsequent dose of oxaliplatin should be reduced from 85 mg / m2 to 65, mg / m in the treatment of metastatic colorectal cancer and to 75 mg / m in adjuvant therapy,
• if paresthesia with functional impairment, continued to next cycle, oxaliplatin should be abolished,
• with a decrease in the severity of symptoms of neurotoxicity after the abolition of oxaliplatin, it is possible to consider the resumption of treatment. With the development of stomatitis and / or mucositis of the 2nd and more degree of toxicity, treatment with oxaliplatin should be suspended until they are stopped or reduce the manifestations of toxicity to 1 degree.

Patients with renal insufficiency
Data on the use of oxaliplatin in patients with severe renal impairment no. Due to the limited data on the safety and tolerability of the drug in patients with moderate renal impairment, before using the drug should weigh the benefit/risk ratio for the patient. Therapy in this category of patients can be started with the recommended dose, under careful control of renal function. With a mild degree of renal dysfunction dose correction oxaliplatin is not required.
Patients with liver failure
Changing the dosage in patients with mild or moderate liver failure is not required. There are no data on the use of oxaliplatin in patients with severe liver dysfunction.
Elderly patient
The safety profile of oxaliplatin as a means of monotherapy or in combination with 5-fluorouracil in patients older than 65 years is similar to that observed in patients up to 65 years.
Instructions for preparation of the drug solution
When preparing solutions and introducing oxaliplatin, needles and other equipment containing aluminum should not be used.
The drug is dissolved before use in water for injection or in a 5% dextrose solution, obtaining a solution with a concentration of 5 mg/ml oxaliplatin (10 ml of solvent is introduced into the vial of 50 mg, in the vial of 100 mg of 20 ml, in the vial of 150 mg - 30 ml of solvent). The drug thus restored is immediately diluted with 250-500 ml of 5% dextrose solution. The concentration of the resulting oxaliplatin solution should be from 0.2 to 0.7 mg/ml, with 0.7 mg/ml - the highest concentration used in clinical practice at a dose of 85 mg / m2.
To prepare the solution of the drug should be applied only with the recommended solvent.
Do not use the drug undiluted.
Do not use salt solutions (sodium chloride solution) for dissolution of the preparation or dilution of the preparation solution (for preparation of the infusion solution). Do not mix in one container, do not administer simultaneously in one infusion system with other drugs (especially with 5-fluorouracil, basic solutions, trometamol and folic acid preparations containing trometamol in its composition).
Oxaliplatin can be administered in conjunction with the infusion folinievy acid. In this case, the drugs should not be mixed in one infusion container. Folic acid for infusion should be diluted using a 5% glucose solution, but in any case should not be used solutions containing sodium chloride or alkaline solutions.
The prepared solution of the preparation should be transparent and should not contain undissolved particles. Otherwise, the drug solution can not be used. The solution of the drug is used immediately after preparation.
The drug is intended for single use only. Unused solution of the drug should be destroyed.
The drug should be administered in the Central venous line or peripheral vein for 2-6 hours.
In case of extravasation, the drug administration should be stopped immediately.
Materials used for the preparation of the solution and its administration must be destroyed in accordance with the rules of use of cytotoxic drugs.
Overdose
Symptoms: increased side effects described. The antidote is not known.
Treatment: hematological control and symptomatic therapy.
Indications

• Adjuvant therapy of stage III colorectal cancer (Duke C) after radical resection of the primary tumor in combination with 5-fluorouracil and folinic acid,
• disseminated colorectal cancer (as monotherapy or combination therapy in combination with 5-fluorouracil and folinic acid)