MONOFER

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Monofer. Monofer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.

4). Each IV iron administration is associated with a risk of a hypersensitivity reaction. Thus, to minimise risk the number of single IV iron administrations should be kept to a minimum. Posology The posology of Monofer follows a stepwise approach: [1] determination of the individual iron need and [2] calculation and administration of the iron dose(s).

The steps can be repeated after [3] post-iron repletion assessments.

Step 1:

Determination of the iron need: The iron need can be determined using either the Simplified Table (i) or the Ganzoni formula below (ii). The iron need is expressed in mg elemental iron. i.

Simplified Table:

Table 1. 2 500 mg 1500 mg 2000 mg ii.

Ganzoni formula:

Table 2. 4 + Iron for iron stores(C) [mg iron] [kg] [g/dl] [mg iron] (A) It is recommended to use the patient’s ideal body weight for obese patients or pre-pregnancy weight for pregnant women. For all other patients use actual body weight.

g. e. 61145 (C) For a person with a body weight above 35 kg, the iron stores are 500 mg or above. Iron stores of 500 mg are at the lower limit normal for small women. Some guidelines suggest using 10-15 mg iron /kg body weight. (D) Default Hb target is 15 g/dl in the Ganzoni formula.

In special cases such as pregnancy consider using a lower haemoglobin target. iii.

Fixed iron need:

A fixed dose of 1000 mg is given and the patient is re-evaluated for further iron need according to “Step 3: Post-iron repletion assessments”. For patients weighing less than 50 kg use the Simplified table or Ganzoni formula for iron need calculation.

Step 2:

Calculation and administration of the maximum individual iron dose(s): Based on the iron need determined above the appropriate dose(s) of Monofer should be administered taking into consideration the following: The total dose per week should not exceed 20 mg iron/kg bodyweight.

The table presents the adverse drug reactions (ADRs) reported during Monofer treatment in clinical trials and in-market experience. Acute severe hypersensitivity reactions may occur with parenteral iron preparations. They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and/or cardiovascular collapse; fatalities have been reported.

Other less severe manifestations of immediate hypersensitivity, such as urticaria and itching may also occur. In pregnancy, associated foetal bradycardia may occur with parenteral iron preparations. Fishbane reaction characterised by flushing in the face, acute chest and/or back pain and tightness sometimes with dyspnea in association with IV iron treatment may occur (frequency uncommon).

This may mimic the early symptoms of an anaphylactoid/anaphylactic reaction. The infusion should be stopped and the patient's vital signs should be assessed. These symptoms disappear shortly after the iron administration is stopped. They typically do not reoccur if the administration is restarted at a lower infusion rate.

Distant skin discolouration has also been reported post marketing following IV iron administration. e. injection site erythema, -swelling, - burning, -pain, -bruising, -discolouration, -extravasation, -irritation, -reaction. ** Influenza like illness whose onset may vary from a few hours to several days.

Description of selected adverse reactions Delayed reactions may also occur with parenteral iron preparations and can be severe. They are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration.

Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4. 1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Dark brown, non transparent solution. 1 Therapeutic indications Monofer is indicated for the treatment of iron deficiency in the following conditions: • When oral iron preparations are ineffective or cannot be used • Where there is a clinical need to deliver iron rapidly The diagnosis must be based on laboratory tests.

In relation to acute blood loss, haemoglobin is sufficient as a diagnostic laboratory test. 2 Posology and method of administration Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Monofer.

Monofer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. 4). Each IV iron administration is associated with a risk of a hypersensitivity reaction.

Thus, to minimise risk the number of single IV iron administrations should be kept to a minimum. Posology The posology of Monofer follows a stepwise approach: [1] determination of the individual iron need and [2] calculation and administration of the iron dose(s).

The steps can be repeated after [3] post-iron repletion assessments.

Step 1:

Determination of the iron need: The iron need can be determined using either the Simplified Table (i) or the Ganzoni formula below (ii). The iron need is expressed in mg elemental iron. i.

Simplified Table:

Table 1. 2 500 mg 1500 mg 2000 mg ii.

Ganzoni formula:

Table 2. 4 + Iron for iron stores(C) [mg iron] [kg] [g/dl] [mg iron] (A) It is recommended to use the patient’s ideal body weight for obese patients or pre-pregnancy weight for pregnant women. For all other patients use actual body weight.

g. g. haemochromatosis, haemosiderosis) • Decompensated liver disease