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General characteristics. Structure:

Active ingredient: 0,5 mg of Dactinomycinum in 1 bottle.

Pharmacological properties:

Pharmacodynamics. Antineoplastic means from group of aktinomitsinovy antibiotics. Inhibits cellular proliferation by formation of a stable complex from DNA and disturbance of DNA-dependent synthesis of RNA. Has an immunodepressive effect.

Pharmacokinetics. Substantially contacts proteins of fabrics. It is metabolized poorly. Does not get through GEB. T1/2 makes 36 h. It is removed with bile - 50% in not changed look, kidneys - 10% in not changed look.

Indications to use:

Vilms's tumor, rhabdomyosarcoma, choriocarcinoma (including metastatic), a metastatic neseminomatozny carcinoma of testicles, Kaposha's sarcoma, Ewing's tumor, a melanoma, uviform sarcoma, ovary cancer, a hysterocarcinoma (as a part of the combined and/or complex therapy).

Route of administration and doses:

In/in kapelno, Dactinomycinum is parted, adding 1.1 ml of sterile water for injections. As a result the transparent solution of golden color containing about 500 mkg/ml turns out. The received solution can be added to infusional 5% solution of a dextrose or 0.9% of NaCl solution.
Method of the isolated perfusion. Advantage of a method - the minimum hit of drug to other regions through a system blood stream, drug continues to influence a tumor during the entire period of treatment. The dose is significantly higher than the dose used at a system way of introduction, danger of emergence of additional toxic effects is small. Appoint 50 mkg/kg for the lower extremities and bodies of a basin; 35 mkg/kg - for upper extremities. To corpulent patients, and also in cases of preliminary treatment chemotherapeutic HP and radiation recommend to appoint smaller doses.
The maximum daily dose for adults and children - 15 mkg/kg or 400-600 mkg / кв.м body surfaces in/in within 5 days.
Adult - 500 mkg/days in/in within 5 days. When calculating a dose for patients with obesity or hypostases it is necessary to consider the body surface area that the dose corresponded to Sukhoi body weight.
To children - 15 mkg/kg/days in/in within 5 days.
Alternative course - the general dose makes 2.5 mg / кв.м body surfaces in/in for 1 week. The repeated course of treatment can be carried out not earlier than in 3 weeks (on condition of disappearance of all signs of toxic effects).
At Vilms's tumor use a combination of low doses of Dactinomycinum and radiation therapy, use of a combination therapy with Vincristinum together with surgical treatment and radiotheraphy is possible. Dactinomycinum and Vincristinum apply during 7 cycles, duration of a maintenance therapy - 15 months.
At a rhabdomyosarcoma use the following combinations: Vincristinum and Dactinomycinum; Vincristinum, Dactinomycinum and cyclophosphamide (VAC therapy), all 4 drugs consistently.
To children with an inoperable or metastatic rhabdomyosarcoma appoint VAC chemotherapy.
At a metastatic choriocarcinoma apply consecutive therapy by Dactinomycinum and a methotrexate. Consecutive therapy is applied if is available: stability of credits of a gonadotrophin after 2 successful rates of any drug; increase in credits of a gonadotrophin during treatment; the toxicity interfering adequate therapy.
At not metastatic choriocarcinoma Dactinomycinum and a methotrexate are appointed together and separately both in combination with surgical intervention, and without it.
At metastatic neseminomatozny cancer of testicles Dactinomycinum is used as independent drug. Appoint by cycles on 500 mkg/days of 5 days in a row, each 6-8 weeks, within 4 months and more.
As palliative treatment of sarcoma of Ewing and uviform sarcoma Dactinomycinum is used in/in or for regional perfusion (separately and in combination with other antineoplastic HP or radiotheraphy).
At Ewing's sarcoma use consecutive purpose of Dactinomycinum - 45 mkg / кв.м and cyclophosphamide - 1200 mg / кв.м together with radiation therapy during 18 weeks.
At uviform sarcoma appoint in a combination with radiation therapy that leads to temporary objective improvement and disappearance of pains and discomfort. This palliative effect varies from temporary oppression of growth of a tumor before considerable, but temporary regression of the size of a tumor.

Features of use:

Use during pregnancy. Dactinomycinum is contraindicated at pregnancy. In case of need uses in the period of a lactation it is necessary to stop breastfeeding.

Women of childbearing age have to use reliable methods of contraception during reception of Dactinomycinum.

In pilot studies teratogenic, mutagen and embriotoksichesky action of Dactinomycinum is revealed.

Treatment is carried out under strict control of the doctor having experience with antineoplastic means.

With care apply Dactinomycinum at patients with gout or a nephrolithiasis (including in the anamnesis).

During treatment it is necessary to control miyelodepressiya degree, and also functions of a liver and kidneys, concentration of uric acid in a blood plasma. There are messages that Dactinomycinum can distort results of the bioasseys used for definition of concentration of antibacterial drugs in a blood plasma.

Against the background of therapy do not recommend to carry out vaccination of the patient and members of his family.

At use of Dactinomycinum together with radiation therapy increase of toxic reactions from a GIT and marrow is possible. Extra care is necessary at purpose of Dactinomycinum during two-month radiation therapy of a right-hand tumor of Vilms as at the same time the hepatomegalia and a superactivity of nuclear heating plant were noted.

Dactinomycinum is applied also by means of a method of the isolated perfusion and entered independently or in combination with other antineoplastic drugs or as palliative treatment or as addition to surgical treatment. At introduction by means of perfusion in some cases Dactinomycinum provides more effective temporary improvement, than its system use.

Side effects:

Nausea, vomiting, slackness, weakness, fever, muscular pains, the dispeptic phenomena, gastrointestinal ulcers, toxic hepatitis, ascites, hemopoiesis disturbances (aplastic anemia, an agranulocytosis, a pancytopenia, etc.), a hypocalcemia, an alopecia, damages of skin, heavy damage (corrosion) of soft tissues (when outpouring drug at in introduction).

Interaction with other medicines:

It is incompatible with the drugs oppressing marrow.

Contraindications:

Chicken pox, shingles, children's age (till 1 year), pregnancy, a lactation.

Storage conditions:

In the dry, protected from light place, at a temperature not above 30 °C. To store in the place, unavailable to children. A drug period of validity Kosmegen - 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 1 bottle (bottle) from dark glass of 1 ml from 0,5 mg of the lyophilized powder in a cardboard pack.