Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark
Monover is indicated for the treatment of iron deficiency in the following conditions:
The diagnosis must be based on laboratory tests.
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Monover. Monover 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 Monover injection (see section 4.4).
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.
The posology of Monover 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.
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.
Table 1. Simplified Table:
| Hb (g/dl) | Hb (mmol/l) | Patients with body weight <50 kg | Patients with body weight 50 kg to <70 kg | Patients with body weight ≥70 kg |
|---|---|---|---|---|
| ≥10 | ≥6.2 | 500 mg | 1000 mg | 1500 mg |
| <10 | <6.2 | 500 mg | 1500 mg | 2000 mg |
Table 2. Ganzoni formula:
Iron need = Body weight(A) x (Target Hb(D) – Actual Hb)(B) x 2.4 + Iron for iron stores©
[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. 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] you should multiply Hb [mM] by factor 1.61145
© 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.
The treatment effect should be monitored by blood tests. To reach the target Hb-level, the cumulative iron dose may need adjustment.
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.
Based on the iron need determined above the appropriate dose(s) of Monover should be administered taking into consideration the following:
The total dose per week should not exceed 20 mg iron/kg body weight.
A single Monover infusion should not exceed 20 mg iron/kg body weight.
A single Monover bolus injection should not exceed 500 mg iron.
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 Monover 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.
Monover is not recommended for use in children and adolescents <18 years due to insufficient data on safety and efficacy.
Monover must be administered by the intravenous route either by injection or by infusion. Monover should not be administered concomitantly with oral iron preparations, since the absorption of oral iron might be decreased (see section 4.5).
Monover 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.
Table 3. Administration rates for intravenous bolus injection:
| Volume of Monover | Equivalent iron dose | Administration rate/Minimum administration time | Frequency |
|---|---|---|---|
| ≤5 ml | ≤500 mg | 250 mg iron/minute | 1-3 times a week |
The iron needrequired may be administered in a single Monover 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.
Table 4. Administration rates for intravenous infusion:
| Iron dose | Minimum administration time |
|---|---|
| ≤1000 mg >1000 mg | More than 15 minutes 30 minutes or more |
Monover should be infused undiluted or diluted in sterile 0.9% sodium chloride. For stability reasons, Monover 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. Please refer to section 6.6.
Monover 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.
The ferric derisomaltose in Monover has a low toxicity. The preparation is well tolerated and has a minimal risk of accidental overdosing.
Overdose may lead to accumulation of iron in storage sites eventually leading to haemosiderosis. Monitoring of iron parameters such as serum ferritin may assist in recognising iron accumulation. Supportive measures such as chelating agents can be used.
Shelf life of vials as packaged for sale:
3 years.
Shelf life after first opening of the container (undiluted):
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Shelf life after dilution with sterile 0.9% sodium chloride:
From a microbiological point of view, the product should be used immediately.
This medicinal product does not require any special storage conditions.
For storage conditions of the reconstituted and diluted solution see 6.3.
Type 1 glass vial with chlorobutyle rubber stopper and aluminium cap.
Pack sizes: 1 × 1ml, 5 × 1 ml, 10 × 1 ml, 5 × 2 ml, 10 × 2 ml, 1 × 5ml, 2 × 5 ml, 5 × 5 ml, 1 × 10ml, 2 × 10 ml, 5 × 10 ml.
Not all pack sizes may be marketed.
Inspect vials visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.
Monover is for single use only and any unused solution should be disposed of in accordance with local requirements.
Monover must only be mixed with sterile 0.9% sodium chloride. No other intravenous dilution solutions should be used. No other therapeutic agents should be added. For dilution instructions, see section 4.2.
The reconstituted solution for injection should be visually inspected prior to use. Use only clear solutions without sediment.
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