Posology : מינונים

4.2   Posology and method of administration

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferinject.

Ferinject 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 Ferinject administration (see section 4.4).

Posology
The posology of Ferinject follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments. These steps are outlined below:

Step 1: Determination of the iron need

The individual iron need for repletion using Ferinject is determined based on the patient's body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the iron need. 2 doses may be required to replenish the total iron need, see Step 2 for the maximum individual iron doses.

Iron deficiency must be confirmed by laboratory tests as stated in 4.1.

Table 1: Determination of the iron need
Hb                                             Patient body weight g/dL                mmol/L                below 35 kg        35 kg to <70 kg        70 kg and above <10                 <6.2                       500 mg           1,500 mg               2,000 mg 10 to <14           6.2 to <8.7                   500 mg           1,000 mg               1,500 mg >14                 >8.7                       500 mg            500 mg                 500 mg Step 2: Calculation and administration of the maximum individual iron dose(s) 
Based on the total iron need determined, the appropriate dose(s) of Ferinject should be administered taking into consideration the following:

A single Ferinject administration should not exceed:

•   15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
•   1,000 mg of iron (20 mL Ferinject)

The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject) per week. If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose.

Step 3: Post-iron repletion assessments

Re-assessment should be performed by the clinician based on the individual patient's condition.
The Hb level should be re-assessed no earlier than 4 weeks post final Ferinject 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 (see step 1).

Patients with haemodialysis-dependent chronic kidney disease

A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis- dependent chronic kidney disease patients (see also section 4.4).

Paediatric population

The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years.


Method of administration
Ferinject must only be administered by the intravenous route:
• by injection, or
• by infusion, or
• during a haemodialysis session undiluted directly into the venous limb of the dialyser.

Ferinject must not be administered by the subcutaneous or intramuscular route.

Intravenous injection
Ferinject may be administered by intravenous injection using undiluted dispersion. The maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg iron. The administration rates are as shown in Table 2:

Table 2: Administration rates for intravenous injection of Ferinject

Administration rate /
Volume of Ferinject required           Equivalent iron dose
Minimum administration time

2 to 4 mL                       100 to 200 mg               No minimal prescribed time
>4 to 10 mL                     >200 to 500 mg                   100 mg iron/min >10 to 20 mL                    >500 to 1,000 mg                     15 minutes 
Intravenous infusion
Ferinject may be administered by intravenous infusion, in which case it must be diluted. The maximum single dose is 20 mg iron/kg body weight, but should not exceed 1,000 mg of iron.
For infusion, Ferinject must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3.
Note: for stability reasons, Ferinject should not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the ferric carboxymaltose dispersion). For further instructions on dilution of the medicinal product before administration, see section 6.6.

Table 3: Dilution plan of Ferinject for intravenous infusion

Maximum amount of sterile 0.9% m/V             Minimum
Volume of Ferinject
Equivalent iron dose          sodium chloride          administration time required solution
2      to      4 mL        100      to     200 mg                                       No minimal
50 mL prescribed time
>4      to     10 mL        >200     to     500 mg           100 mL                       6 minutes >10     to     20 mL        >500     to    1,000 mg          250 mL                      15 minutes