MonoFer Dosage/Direction for Use

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. The patient should be observed for adverse effects for at least 30 minutes following each Monofer injection (see Precautions).
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 as follows (ii).
The iron need is expressed in elemental iron.
i. Simplified Table: See Table 1.

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ii. Ganzoni formula: See Equation 1.

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^(A)It is recommended to use the patient's ideal body weight for obese patients or pre-pregnancy weight for pregnant women. Ideal body weight may be calculated in a number of ways e.g. by calculating weight at BMI 25 i.e. ideal body weight = 25 * (height in m)².
^(B)To convert Hb [mM] to Hb [g/dl], multiply Hb [mM] by factor 1.61145.
^(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. For patients weighing less than 50 kg use the Simplified table or Ganzoni formula for iron need calculation.
iv. Iron replacement for blood loss: Iron therapy in patients with blood loss should supply an amount of iron equivalent to the amount of iron represented in the blood loss.
If the Hb level is reduced: Use the Ganzoni formula considering that the depot iron does not need to be restored: See Equation 2.

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If the volume of blood lost is known: The administration of 200 mg Monofer results in an increase of haemoglobin which is equivalent to 1 unit blood: See Equation 3.

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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: A single Monofer infusion should not exceed 20 mg iron/kg body weight.
Step 3: Post-iron repletion assessments: Re-assessment including blood tests should be performed by the clinician based on the individual patient's condition. A full response can take up to six-eight weeks. An improvement of well-being occurs within a few days, the reticulocyte count rises in one week, and haemoglobin increments are seen in one or two weeks. Depending on the severity of anaemia, normal levels will be reached in most patients in one or two months. In the event the patient requires further iron repletion, the iron need should be recalculated.
Children and adolescents: Monofer is not recommended for use in children and adolescents <18 years due to insufficient data on safety and efficacy.
Method of administration: Monofer can be administered by the intravenous route either by injection or by infusion.
Intravenous bolus injection: Monofer may be administered as an intravenous bolus injection up to 500 mg up to three times a week at an administration rate of up to 250 mg iron/minute. It may be administered undiluted or diluted in maximum 20 ml sterile 0.9% sodium chloride. (See Table 2.)

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Intravenous infusion: The iron need required may be administered in a single Monofer infusion up to 20 mg iron/kg body weight or as weekly infusions until the cumulative iron need has been administered.
If the iron need exceeds 20 mg iron/kg body weight, the dose must be split in two administrations with an interval of at least one week. It is recommended whenever possible to give 20 mg iron/kg body weight in the first administration. Dependent on clinical judgement the second administration could await follow-up laboratory tests. (See Table 3.)

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Monofer should be infused undiluted or diluted in sterile 0.9% sodium chloride. For stability reasons, Monofer should not be diluted to concentrations less than 1 mg iron/ml (not including the volume of the Monofer solution). Do not dilute in more than 500 ml. Refer to Special precautions for disposal and other handling under Cautions for Usage.
Injection into dialyser: Monofer may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as outlined for intravenous bolus injection.