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The distribution of Treanda 100mg.
After a single 30-minute intravenous infusion of bendamustine at a dose of 100 mg / m2 of body surface, the beta-phase elimination is 28.3 minutes. The volume of distribution with a 30-minute intravenous infusion is 19.3 liters, with subsequent systematic administration and achievement of an equilibrium concentration, the volume of distribution ranges from 15.8 to 20.5 liters. In the systemic circulation, bendamustine actively binds to plasma proteins (> 95%), mainly with albumin.
The ability of bendamustine to bind to blood plasma proteins is not impaired at low concentrations of albumin in the blood plasma, in patients over the age of 70 years and in the late stages of tumors.
Bendamustine hydrochloride is metabolized predominantly in the liver. The main way to remove bendamustine hydrochloride from the body is its hydrolysis with the formation of monohydroxy – and dihydroxybendamustine. In the formation of gamma-hydroxybendamustine (M3) and N-desmethylbendamustine (M4), the isoenzyme CYP 1A2 cytochrome P450 is involved in the liver. In vitro, bendamustine does not inhibit CYP 1A4, CYP 2C9 / 10, CYP 2D6, CYP2E1 and CYP3A4.
Elimination and excretion.
The average total clearance after a 30-minute intravenous infusion of the remedy to 12 subjects at a dose of 100 mg / m2 of the body surface was 639.4 ml / min. About 20% of the administered dose of the remedy was excreted by the kidneys for 24 hours.
The amounts of the unchanged bendamustine and its metabolites excreted with the kidneys are arranged in descending order as follows: monohydroxybendamustine> bendamustine> dihydroxybendamustine> oxidized metabolite> N-desmethylbendamustine.
Mainly polar metabolites are excreted with bile.
Indications for using of Treanda 100mg.
Chronic lymphocytic leukemia (efficacy in first-line therapy compared with other chemotherapy remedies other than chlorambucil has not been established).
Non-Hodgkin’s lymphoma in non-Hodgkin’s monotherapy in patients who have progressed with or against the background of or within 6 months after the end of therapy with rituximab and in combination therapy as first-line therapy.
Contraindications to the using Treanda 100mg.
Hypersensitivity to the active substance or any of the auxiliary components or their intolerance;
Pregnancy and lactation;
Moderate and severe hepatic impairment;
The number of neutrophils is less than 1500 / μl and / or platelets less than 75,000 / μL;
Surgical interventions less than 30 days before therapy;
Infections, especially those accompanied by leukocytopenia;
Child age (lack of data on effectiveness and safety).