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 or the Ganzoni formula as follows.
The iron need is expressed in mg elemental iron.
Simplified Table: See Table 1.

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Ganzoni formula: See equation.

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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" as follows. 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.
A single Monofer infusion should not exceed 20 mg iron/kg body weight.
A single Monofer bolus injection should not exceed 500 mg iron.
Step 3: Post-iron repletion assessments: Re-assessment including blood tests should be performed by the clinician based on the individual patient's condition. To evaluate the effect of IV iron treatment, the Hb level should be re-assessed no earlier than 4 weeks post final Monofer administration to allow adequate time for erythropoiesis and iron utilisation. 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 must be administered by the intravenous route either by injection or by infusion.
Monofer should not be administered concomitantly with oral iron preparations, since the absorption of oral iron might be decreased (see Interactions).
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 ferric derisomaltose solution) and never diluted 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.