Mitotax solution for injections 6 mg/ml. 250 mg/41.7 ml. №1 vial

Description

Mitotax composition
active substance: paclitaxel;
1 ml of solution contains paclitaxel 6 mg;
excipients: polyethoxylated castor oil, anhydrous ethanol, anhydrous citric acid.

Dosage form
Solution for injection.

Pharmacological properties
It is an antineoplastic agent. It is an antimitotic agent that acts on the microtubule apparatus of cells. It stimulates the formation of microtubules from tubulin dimers, stabilizes them, preventing depolymerization. At the same time, the normal process of reorganization of microtubule networks, which is important for the stages of interphase, mitosis, is disrupted.

Indications
Mitotax is used:

• with ovarian cancer;
• with advanced cancer (non-small cell) of the lung;
• with breast cancer;
• with Kaposi’s sarcoma (multiple hemorrhagic sarcomatosis) in AIDS patients.

Contraindications
Mitotax is not used:

• if you are allergic to paclitaxel;
• with intolerance to auxiliary components;
• with neutropenia before starting therapy;
• with uncontrolled infections in patients with Kaposi’s sarcoma.

Application during pregnancy and lactation
Mitotax should not be used during pregnancy, lactation.
The drug has embryotoxic and fetotoxic effects.

Method of administration and dosage
Mitotax is used parenterally. The solution is injected intravenously using infusion systems with built-in membrane filters (the required pore size is less than 0.22 microns).
The patient should receive premedication with glucocorticosteroids, antihistamines, H2-receptor antagonists.

• The standard dose for chemotherapy of the 1st line of ovarian cancer (with cisplatin) is 135 mg / m2 in the form of 24-hour intravenous infusions, after which cisplatin (75 mg / m2) is used. The interval between courses of therapy is three weeks.
• The standard dose for chemotherapy of the II line of ovarian cancer is 175 mg / m2 by three-hour infusion every three weeks.
• The standard dose for adjuvant chemotherapy for breast cancer (after chemotherapy with anthracyclines, cyclophosphamide) is 175 mg / m2 by three-hour infusion. Shown 4 courses of therapy with a weekly interval.
• The standard dose for chemotherapy of the 1st line of breast cancer (one day after doxorubicin) is 175 mg / m2 by three-hour infusion. The interval between courses is three weeks.
  The standard dose for chemotherapy of the II line of breast cancer is 175 mg / m2 by three-hour infusion every three weeks.
• The standard chemotherapy dose for advanced non-small cell lung cancer (with cisplatin) is 175 mg / m2 by three-hour infusion followed by cisplatin. The interval between courses of therapy is three weeks.
• The standard dose for chemotherapy of Kaposi’s sarcoma in AIDS patients is 135 mg / m2 as a three-hour infusion every three weeks or 100 mg / m2 as a three-hour infusion every two weeks.

Overdose
Overdose symptoms: bone marrow suppression, mucositis, peripheral neurotoxicity.
In case of signs of an overdose, immediately stop the administration of the solution, carry out symptomatic treatment.

Side effects:

• Gastrointestinal disorders: nausea, diarrhea, mucositis, vomiting, obstruction, intestinal perforation, neutropenic enterocolitis (typhlitis), mesenteric artery thrombosis.
• Hepatobiliary disorders: an increase in the values ​​of AST, bilirubin, alkaline phosphatase in the blood, encephalopathy of hepatic origin, liver necrosis.
• Hematological disorders: neutropenia, thrombocytopenia, anemia.
• Immune disorders: allergic reactions (rash, itching, urticaria, redness of the face and skin, angioedema, bronchospasm, shortness of breath), anaphylactic shock.
• Cardiovascular disorders: arterial hypotension / hypertension, bradycardia, ECG changes, thrombosis, thrombophlebitis, cardiomyopathy, ventricular tachycardia, AV block, syncope, myocardial infarction, heart failure.
• Genitourinary disorders: renal failure.
• Dermatological disorders: pigmentation disorders, discoloration of the nail bed, transient skin changes, maculopapular rashes, itching.
• Musculoskeletal disorders: arthralgia, myalgia.
• Respiratory disorders: interstitial pneumonia, pulmonary fibrosis, pulmonary embolism, radiation pneumonitis.
• Neurological disorders: peripheral neuropathy, paresthesias, grand mal seizures, scotoma, ataxia, encephalopathy, paralytic intestinal obstruction.
• Reactions at the injection site: local edema, erythema, pain, induration, cellulite, skin pigmentation.

Storage conditions and periods
Store Mitotax for no more than two years at temperatures up to +25 ° C.