MIRCERA ® Methoxy polyethylene glycol-epoetin beta

MIRCERA ® is a drug based on methoxy polyethylene glycol-epoetin beta.

THERAPEUTIC GROUP: Antianemic - hormones and related substances.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications MIRCERA ® Cera

MIRCERA ® is used in the treatment of symptomatic anemia associated with chronic renal failure.

No studies have yet been completed on the efficacy and safety of MIRCERA ® in different pathological conditions.

Mechanism of action MIRCERA ® Cera

Methoxy polyethylene glycol-epoetin beta falls into the category of continuous receptor activators for erythropoietin (CERA), due to its decidedly different pharmacokinetic properties compared to the other forms of epoetin. This molecule, which is enriched with a long protein chain compared to the common analogues of erythropoietin and erythropoietin itself, is able to exercise a different activation of the receptor for erythropoietin, characterized by a slow association and a rapid dissociation, which greatly increases its effectiveness. Furthermore, the long half-life, estimated at around 139 hours and evidently greater than the few hours of the other forms, makes it possible to reduce the frequency of administration, while maintaining high efficacy. It has been estimated that following the subcutaneous intake of methoxy polyethylene glycol-epoetin beta, the maximum concentrations are obtained after 72 hours, with a high bioavailability of the drug, equal to about 62% of the total dose taken, and a half-life of about 139 hours.

Although MIRCERA has a decidedly different pharmacokinetic profile than the other recombinant erythropoietins, the mechanism of action remains the same; it acts as an analogous erythropoietin endogenous, activating the EPO receptor expressed on the surface of medullary erythrocyte precursors, which stimulates mitosis and subsequent differentiation into erythrocytes.

Studies carried out and clinical efficacy

WAX: SAFETY PROFILE

This study, conducted on almost 2000 patients, showed that the incidence of side effects in subjects undergoing CERA therapy is lower than that observed following administration of other synthetic erythropoietin analogues. This Italian work underlines the greater safety of the treatment with CERA.

2. THE ADVANTAGES AND THE EFFECTIVENESS OF THE WAXING SUMMARY

CERA was administered to patients with chronic renal failure, in order to correct the anemia resulting from this pathological condition. The administration of this continuous activator of the erythropoietin receptor, allowed to maintain excellent and constant hemoglobin concentrations with a single monthly administration, compared to the four required for other analogues.

3. WAX AND DOPING

CERA represents third-generation erythropoietin, frequently used in endurance sports to improve performance. New tests based on robotic and standardized methods are supplanting the old immunoenzymatic methods, allowing a rapid diffusion of these tests useful to fight an illegal, unsportsmanlike and harmful health for the athlete.

Method of use and dosage

MIRCERA ® 30mcg / 0.3ml pre-filled syringes; 50mcg / 0.3ml; 75mcg / 0.3ml; 100 mcg / 0.3 ml; 120mcg / 0.3 ml; 150mcg / 0.3 ml; 200mcg / 0.3ml; 250mcg / 0.3ml; 360mcg / 0.6ml; 8000UI / 0.8ml; 10000UI / 1ml; 40000IU / 1ml of methoxy polyethylene glycol-epoetin beta : the choice of dosage, therapeutic procedure and method of administration is of exclusive medical relevance, and should take into account the degree of anemia, the age of the patient, and any hemodialysis therapy, of individual susceptibility, of the efficacy of the treatment (to be evaluated in ongoing therapy) and of the therapeutic objectives, taking into account that the administration of MIRCERA should stop once it reaches Hb values ​​equal to 12g / dL.

IN ANY CASE, BEFORE TAKING MIRCERA ® Wax - THE REQUIREMENT AND CHECK OF YOUR DOCTOR IS NECESSARY.

Warnings MIRCERA ® Cera

Treatment with MIRCERA ® is subject to the presence of an anemic picture of chronic renal failure, and not due to a lack of elements such as folic acid, vitamin B12 or iron. Therefore, it would be advisable to closely monitor both the markers of the martial metabolism and the concentrations of folic acid and vitamin B12, so that a possible integration could be a solution to the anemic picture, or may justify the therapy with methoxy polyethylene glycol-epoetin beta.

The effectiveness of the therapy, in the course of work, could in fact be compromised, as well as by a lack of the aforementioned elements, also by occult hemorrhages, inflammations or by the production of anti-erythropoietin antibodies, identifying a pure erythroid aplasia. In the latter case it is advisable to suspend therapy, avoiding the administration of other erythropoietins, for possible cross-reactivity.

In patients with hypertension it might be useful to set up a supportive antihypertensive therapy, in order to avoid unpleasant side events.

The therapeutic target, set on hemoglobin values ​​of 12g / dL, is such as several studies have demonstrated the ineffectiveness of methoxy polyethylene glycol-epoetin beta therapy in supporting a further increase, associated at the same time with a potential increase in side effects.

Indeed, it should be reiterated that receptors for erythropoietin can also be expressed by tumor cells, which could use EPO agonists as growth factors. This process could underlie the observed results, characterized by an increase in mortality in cancer patients treated with EPO.

MIRCERA does not adversely affect the ability to drive vehicles or use machinery; however some side effects, evident above all in the first phase of the treatment could reduce the perceptive capacities of the patient.

PREGNANCY AND BREASTFEEDING

At present, studies conducted on animal models have not shown any particular toxic effects of methoxy polyethylene glycol-epoetin beta on the health of the fetus, except for a slight decrease in birth weight. Despite these studies, it would still be advisable to avoid taking MIRCERA during pregnancy.

Animal studies have also shown that part of the methoxy polyethylene glycol-epoetin beta is secreted in breast milk; therefore, also considering the absence of studies on men, it is preferable to suspend breast-feeding during any therapy with this drug.

Interactions

No interaction studies have been performed yet, but the probability that MIRCERA alters the normal efficacy of other active ingredients or any pharmacokinetic properties is very low.

Contraindications MIRCERA ® Cera

MIRCERA ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, in the case of uncontrolled hypertension and pure aplasia of the red series cells, even if observed following the assumption of other forms of recombinant erythropoietin.

Undesirable effects - Side effects

In addition to clinically insignificant disorders observed in the initial phase of treatment, such as dizziness, drowsiness and asthenia, the most important and most frequently observed side reactions were hypertension, thrombosis and headache.

Rare cases of hypersensitivity, skin rush, and hypertensive encephalopathy have been more rare.

Note

MIRCERA ® can be sold only under specialized medical prescription (nephrologist, internist, hematologist, oncologist, anesthesiologist, blood transfusionist, pediatrician, surgeon).

The use of MIRCERA ® in sports, without there being a real therapeutic need, constitutes DOPING, which - in addition to being an unfair practice in terms of sportsmanship and punishable by law - exposes the athlete to serious risks for the own health.

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