Iroject

Indication

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients:

• who have intolerance to oral iron or have had unsatisfactory response to oral iron

• who have non-dialysis dependent chronic kidney disease

Dosage & Administration

The posology of Ferric Carboxymaltose follows a step wise approach: Step-1: determination of the

individual iron need, Step-2: calculation and administration of the iron dose(s) and Step-3: post-iron

repletion assessments. This steps are outlined below:

Step-1: Determination of the individual iron need

The individual iron need for repletion using Iroject is determined based on patient’s body weight and

hemoglobin (Hb) level. The following Table-1 for determination of the iron need:

Table-1 for determination of the iron need:

Note:Iron deficiency must be confirmed by laboratory test

Step-2: Calculation and administration of the maximum individual iron dose(s)

Based on the iron need determined above the appropriate dose(s) of Ferric Carboxymaltose should

be administered taking into consideration the following:

A single Ferric Carboxymaltose 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)

•The maximum recommended cumulative dose of Ferric Carboxymaltose is 1,000 mg of iron per

week

Step-3: Post-iron repletion assessments

Re-assessments 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 Ferric Carboxymaltose

administration to allow adequate time for the erythropoiesis and iron utilization. In the event the

patient requires further iron repletion, the iron need should be recalculated using Table-1 above.

Method of Administration

Intravenous injection: Iroject may be administered by intravenous injection using undiluted solution.

The maximum single dose is 15 mg Iron/Kg body weight but should not exceed 1,000 mg of iron. The

administration rates are as shown in Table 2:

Table 2: Administration rates for intravenous injection of Iroject

Intravenous infusion: Iroject 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

iron. For infusion, Ferric Carboxymaltose must only be diluted in sterile 0.9% Sodium Chloride

solution as shown in Table 3.

Iroject must be administered only by the intravenous route: By bolus injection or during a

hemodialysis session undiluted directly into the venous limb of the dialyzer or by drip infusion. In case

of drip infusion Iroject must be diluted only in sterile 0.9% Sodium Chloride solution as follows:

Table 3: Dilution Procedure for IV Injection

Note: for stability reasons, Iroject should not be diluted to concentrations less than 2 mg Iron/ml.

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

Use in special population

Use in hemodialysis dependent chronic kidney disease: A single maximum daily injection dose of 200

mg iron should not be exceed in hemodialysis-dependent chronic kidney disease patients.

Use in paediatric population: The use of Ferric Carboxymaltose has not been studied in children, and

therefore is not recommended in children under 14 years.

Precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric Carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious adverse reactions associated with hypersensitivity which included, but not limited to,pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension

Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric Carboxymaltose administration.

Laboratory Test Alterations

In the 24 hours following administration of Ferric Carboxymaltose, laboratory assays may

overestimate serum iron and transferrin bound iron by also measuring the iron in Ferric

Carboxymaltose.

Use in Pregnancy and Lactation

Pregnancy: There are no data for the use of Ferric Carboxymaltoxse in pregnant women. A careful

risk/benefit evaluation is required before use during pregnancy and Ferric Carboxymaltoxse should

not be used during pregnancy unless clearly necessary. Animal data suggest that iron released from

Ferric Carboxymaltose can cross the placental barrier and that its use during pregnancy may

influence skeletal development in the fetus.

Treatment with Ferric Carboxymaltose should be confined to the second and third trimester if the

benefit is judged to outweigh the potential risk for both the mother and the fetus.

Lactating mothers: Based on limited data on breast-feeding women it is unlikely that Ferric

Carboxymaltoxse represents a risk to the breast-fed child.