Ferinject Dosage/Direction for Use

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of ferric carboxymaltose (Ferinject).
Ferric carboxymaltose (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 ferric carboxymaltose (Ferinject) administration (see Precautions).
Posology: The posology of ferric carboxymaltose (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 as follows: Step 1: Determination of the iron need: The individual iron need for repletion using ferric carboxymaltose (Ferric carboxymaltose (Ferinject)) is determined based on the patient's body weight and hemoglobin (Hb) level. Refer to Table 1 for determination of the total iron need. 2 doses may be required to replenish the total iron need, see Step 2 for the maximum individual iron doses. (See Table 1.)

Click on icon to see table/diagram/image

Step 2: Calculation and administration of the maximum individual iron dose(s): Based on the total iron need determined as previously mentioned the appropriate dose(s) of Ferric carboxymaltose (Ferinject) should be administered taking into consideration the following: Adults and adolescents aged 14 years or older: A single Ferric carboxymaltose (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 Ferric carboxymaltose (Ferinject)).
The maximum recommended cumulative dose of Ferric carboxymaltose (Ferinject) is 1,000 mg of iron (20 mL Ferric carboxymaltose (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.
Children and adolescents aged 1 to 13 years: A single Ferric carboxymaltose (Ferinject) administration should not exceed: 15 mg iron/kg body weight; 750 mg of iron (15 mL Ferric carboxymaltose (Ferinject)).
The maximum recommended cumulative dose of Ferric carboxymaltose (Ferinject) is 750 mg of iron (15 mL Ferric carboxymaltose (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).
Children below 1 year of age: The efficacy and safety of Ferric carboxymaltose (Ferinject) has not been investigated in children below 1 year of age. Ferric carboxymaltose (Ferinject) is therefore not recommended for use in children in this age group.
Patients with haemodialysis-dependent chronic kidney disease: In adults and adolescents aged 14 years and older, a single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients (see Precautions).
Children below 1 year of age: The efficacy and safety of Ferric carboxymaltose (Ferinject) has not been investigated in children below 1 year of age. Ferric carboxymaltose (Ferinject) is therefore not recommended for use in children in this age group.
Method of administration: Ferric carboxymaltose (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.
Ferric carboxymaltose (Ferinject) must not be administered by the subcutaneous or intramuscular route.
Intravenous injection: Ferric carboxymaltose (Ferinject) may be administered by intravenous injection using undiluted dispersion. In adults and adolescents aged 14 years and older, the maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron. The administration rates are as shown in Table 2: See Table 2.

Click on icon to see table/diagram/image

Intravenous infusion: Ferric carboxymaltose (Ferinject) may be administered by intravenous infusion, in which case it must be diluted. In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg iron/kg body weight, but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron.
For infusion, Ferric carboxymaltose (Ferinject) must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferric carboxymaltose (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 Special precautions for disposal and other handling under Cautions for Usage. (See Table 3.)

Click on icon to see table/diagram/image