Maltofer

Maltofer Mechanism of Action

iron polymaltose

Manufacturer:

Vifor Pharma

Distributor:

Zuellig Pharma
Full Prescribing Info
Action
Pharmacotherapeutical group: iron preparation. ATC Code: B03AB05.
Pharmacology: Properties: In the iron(III)-hydroxide polymaltose complex, the polynuclear iron(III)-hydroxide core is superficially surrounded by a number of non-covalently bound polymaltose molecules resulting in an overall average molecular weight of approximately 50 kDa. The polynuclear core of IPC has a structure similar to that of the physiological iron storage protein, ferritin. IPC is a stable complex and does not release large amounts of iron under physiological conditions. Because of its size, the extent of diffusion of IPC through the membrane of the mucosa is about 40 times less than that of the hexaquo-iron(II) complex. Iron from IPC is taken up in the gut via an active mechanism.
Pharmacodynamics: The iron absorbed is bound to transferrin and is used for Hb synthesis in the bone marrow or stored primarily in the liver bound to ferritin.
Clinical Efficacy: The efficacy of Maltofer compared to a placebo or similar preparations with different iron formulations in terms of normalising haemoglobin values and replenishing iron stores has been demonstrated in numerous clinical studies in infants, children, adolescents and adults. Both solid and liquid galenic forms of IPC were used in these studies. The primary goal of an oral iron replacement is to maintain the body's own iron stores within normal limit values (to prevent an iron deficiency, e.g. in case of increased requirements), replenish iron stores or correct existing iron deficiency anaemia.
Clinical studies in adults: A total of 11 controlled clinical studies have been carried out with IPC mono-preparations in comparison with a placebo and/or oral iron(II) preparations.
A total of more than 900 patients were involved, and approximately 500 of these patients received IPC mono-preparations. The patient population studied demonstrated no relevant differences in haematological and iron parameters (haemoglobin (Hb), mean red blood cell haemoglobin (MCV), serum ferritin) at the start of treatment. The oral iron replacement with IPC at a dose of 100-200 mg iron/day for several weeks up to a maximum of 6 months demonstrated a clinically relevant increase in iron and haematological parameters at the end of treatment compared to those at the start of treatment. The improvement in haematological parameters (Hb, MCV, serum ferritin) after a 12 week treatment with IPC was comparable to treatment with iron(II) sulphate.
The efficacy of IPC compared to iron(II) sulphate was investigated on the basis of a meta-analysis of 6 prospective, randomised clinical studies in adult patients with iron deficiency anaemia. The total number of patients included in the study was 557; 319 patients received IPC and 238 patients iron(II)sulphate. The pooled mean haemoglobin values at the start of treatment were 10.35 ±0.92 g/dL (IPC) and 10.20 ±0.93 g/dL (iron(II) sulphate). After an average treatment period of 8 to 13 weeks with equivalent posology, mean haemoglobin values were determined.[12.13 ±1.19 g/dL (IPC) and 11.94 ±1.84 g/dL (iron(II) sulphate), p=0.93]. Increases in haemoglobin were greater after a longer treatment duration for both iron formulations.
Clinical studies in children and adolescents: The use of Maltofer in children and adolescents (18 years old or younger) was investigated in a number of clinical studies involving over 1000 patients. The efficacy of Maltofer in terms of improving iron values compared to the placebo or comparable preparations with different iron formulations was thereby confirmed.
Pharmacokinetics: Absorption: Studies with radio-labelled IPC show a good correlation between iron absorption and build-up of iron in haemoglobin. The relative absorption of iron correlates with the degree of iron deficiency (i.e. the greater the iron deficiency, the higher the iron absorption). In contrast to iron(II) salts, it was determined that food had no negative effect on the bioavailability of iron from Maltofer: significantly increased bioavailability of iron with concomitant ingestion of food was demonstrated in a clinical study, while three other studies showed a positive trend but no clinically significant effects.
Elimination: Iron that is not absorbed is eliminated in the faeces.
Toxicology: Preclinical data: Non-clinical data obtained for IPC does not reveal any special hazards for humans based on conventional studies of individual dose toxicity and repeated dose toxicity, genotoxicity or reproduction and development toxicity.
The LD50 of IPC, which was determined in animal trials with mice and rats, was higher than an orally administered dose of 2‚000 mg of iron per kg of body weight
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