Iroject IV Injection or Infusion

Iroject 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.

Iroject is a colloidal iron (III) hydroxide in complex with Carboxymaltose, a Carbohydrate
polymer that releases iron.

The posology of Ferric Carboxymaltose follows a stepwise approach:

1. determination of the individual iron need
2. calculation and administration of the iron dose(s)
3. post-iron repletion assessments.

Step 1: Determination of the iron need: The individual iron need for repletion using Fematos is determined based on the patient's body weight and haemoglobin (Hb) level. The following list for determination of the iron need:

Hb <10 g/dl

• below 35 kg: 500 mg
• 35 kg to <70 kg: 1500 mg
• 70 kg and over: 2000 mg

Hb 10 to 14 g/dl

• below 35 kg: 500 mg
• 35 kg to <70 kg: 1000 mg
• 70 kg and over: 1500 mg

Hb >14 g/dl

• below 35 kg: 500 mg
• 35 kg to <70 kg: 500 mg
• 70 kg and over: 500 mg

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 1000 mg of iron per week.

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 Ferric Carboxymaltose 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 using above list.

Formal drug interaction studies have not been performed with Iroject.

The use of Ferric Carboxymaltose is contraindicated in cases of:

• hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients
• known serious hypersensitivity to other parenteral iron products
• anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
• evidence of iron overload or disturbances in the utilisation of iron

The side effects of Iroject are infrequent, usually mild & generally do not cause patients to stop treatment.

The most common side effect: nausea, followed by headache, dizziness, and hypertension, injection site reactions, nausea, alanine aminotransferase increased, hypophosphataemia.

Uncommon side effects: hypersensitivit, dysgeusia, tachycardia, hypotension, flushing, dyspnoea, dyspepsia, abdominal pain, constipation, diarrhea, Pruritus, urticaria, erythema, rash, myalgia, back pain, arthralgia, muscle spasms, Pyrexia, fatigue, chest pain, oedema peripheral, chills, aspartate aminotransferase increased, gamma glutamyl transferase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased.

Rare side effects: anaphylactoid reactions, loss of consciousness, anxiety, phlebitis, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise, influenza like illness.

There are no adequate and well-controlled trials of Ferric Carboxymaltose in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and Ferric Carboxymaltose 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. Based on limited data on breast-feeding women it is unlikely that Ferric Carboxymaltose represents a risk to the breast-fed child.

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Iroject. Patients may present with shock, clinically significant hypotension, loss of consciousness and collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Iroject administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Iroject when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially 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 may be occured. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Iroject administration.

Laboratory Test Alterations: In the 24 hours following administration of Iroject, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Iroject.

Patients with haemodialysis-dependent chronic kidney disease: A single maximum daily injection dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients.

Paediatric population: The use of Iroject has not been studied in children, and therefore is not recommended in children under 14 years.

Excessive dosages of Iroject may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognising iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator.

Parenteral Iron Preparations

Store in a cool (below 30°C) & dry place, away from light. Do not freeze. Keep out of the reach of children.