Medaxa powder for solution for infusions 5 mg/ml. 100 mg. vial №1

Description

Medaxa composition
active substance: oxaliplatin;
1 vial contains 100 mg of oxaliplatin; 1 ml of reconstituted solution contains 5 mg of oxaliplatin;
Excipient: lactose monohydrate.

Dosage form
The powder is lyophilized to prepare a solution for infusion.

Pharmacological properties
The drug in question Medaxa belongs to the group of antineoplastic drugs consisting of platinum compounds.
The main active ingredient is oxaliplatin. It is an anticancer substance composed of platinum compounds. As a result of metabolic processes, the atoms of this metal produce compounds in the form of complexes of diaminocyclohexane and oxalate.
Oxaliplatin is the only platinum enantiomer. It has a wide cytotoxic spectrum of action, as well as antitumor activity, and affects various types of tumor processes, including colorectal cancer.
It is also active against tumors resistant to cisplatin.
The action of the drug is based on the ability of aqueous derivatives, formed as a result of biological transformation of oxaliplatin, are capable of interacting with DNA, while forming intra-strand cross-bridges of these compounds. As a result, DNA synthesis is destroyed, antitumor and cytotoxic effects are produced, and the tumor dies.

Indications
Medaxa is used in the treatment of certain cancers.
In particular, oxaliplatin is used in combination with 5-fluorouracil and folinic acid:

• for adjuvant therapy of stage III (Duke stage C) colon cancer after complete removal of the primary tumor;
• for the treatment of metastatic colorectal cancer.

Contraindications
The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
Contraindicated in:

• myelosuppression before starting the first course of treatment;
• peripheral sensory neuropathy with functional impairment before starting the first course of treatment;
• severe renal failure.

Children
It is not used in pediatrics.

Application during pregnancy and lactation
This drug is not used in the treatment of pregnant or lactating women.

Method of administration and dosage
Medaxa is used as an infusion.
The use of oxyplatin is recommended:

• for adjuvant therapy – at the rate of 85 mg of the drug per 1 square meter of body surface (PT) every 2 weeks for 12 cycles of therapy, which are carried out over six months;
• in the treatment of metastatic colorectal cancer, it is at the rate of 85 mg of the drug per 1 square meter of body surface, every 2 weeks until the development of the disease stops.

Oxaliplatin is administered as an intravenous infusion lasting 2-6 hours diluted in 250-500 ml of 5% glucose solution.
For a treatment regimen repeated every two weeks, a dosing regimen in the form of a bolus of 5-fluorouracil and a continuous infusion of 5-fluorouracil is recommended.
The exact dosage, schemes and frequency of treatment courses, their adjustment is determined by the attending physician individually, depending on the nature and course of the disease, the reaction to the drug.
In case of extravasation, the drug is immediately discontinued.

Overdose
So far, no cases of overdose have been observed.
Theoretically, in the event of an overdose, an aggravation of adverse reactions is possible.
In this case, it is necessary to begin hematological control simultaneously with symptomatic treatment.

Side effects
The drug is usually well tolerated. In rare cases of hypersensitivity, adverse reactions may occur. In this case, such reactions are possible as:

• decrease in blood pressure, body temperature;
• dyspeptic disorders (nausea, vomiting, diarrhea);
• disorders of the liver and kidneys;
• allergic reactions, rash, itching, allergic urticaria;
• anemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia;
• neuropathy, sensory disturbances, dysgeusia;
• shortness of breath, cough;
• stomatitis, alopecia, weight fluctuations;
• fatigue, asthenia;
• venous thrombosis;
• insomnia, nervousness, depression;
• conjunctivitis.

Storage conditions and periods
Shelf life – 4 years from the date of manufacture indicated on the package.
The storage temperature should not exceed 25 ° C.