Ferric Carboxymaltose

Ferric Carboxymaltose is used for: Iron deficiency anemia, Indicated for the treatment of iron deficiency when – oral iron preparations are ineffective – oral iron preparations cannot be used – there is a clinical need to deliver iron rapidly The diagnosis of iron deficiency must be based on laboratory tests.

Injection Iron-deficiency Anemia Determination of the iron need The individual iron need is determined based on the patient's body weight and haemoglobin (Hb) level. • If Hb is <10 (g/dL) or <6.2 mmol/L and Patient body weight is below 35 kg then dose is 500 mg • If Hb <10 (g/dL) or <6.2 mmol/L and Patient body weight is 35 kg to <70 kg then dose is 1500 mg • If Hb <10 (g/dL) or <6.2 mmol/L and Patient body weight is 70 kg and above then dose is 2000 mg • If Hb 10 to <14(g/dL) or 6.2 to <8.7 mmol/L and Patient body weight is below 35 kg then dose is 500 mg • If Hb 10 to <14(g/dL) or 6.2 to <8.7 mmol/L and Patient body weight is 35 kg to <70 kg then dose is 1000 mg • If Hb 10 to <14(g/dL) or 6.2 to <8.7 mmol/L and Patient body weight is 70 kg and above then dose is 1500 mg • If Hb >14 (g/dL) or >8.7 mmol/L and Patient body weight is below 35 kg then dose is 500 mg • If Hb >14 (g/dL) or >8.7 mmol/L and Patient body weight is 35 kg to <70 kg then dose is 500 mg • If Hb >14 (g/dL) or >8.7 mmol/L and Patient body weight is 70 kg and above then dose is 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 1,000 mg of iron (20 mL Ferric Carboxymaltose) 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.

Safety and efficacy not established

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. Nondialysis dependent chronic kidney disease >50 kg: 750 mg IV once, follow 7 days later with second 750 mg dose; not to exceed cumulative dose of 1500 mg per course <50 kg: 15 mg/kg IV once, follow 7 days later with second dose; not to exceed 1500 cumulative dose per course

IV Preparation For IV infusion, dilute in up to 250 mL 0.9% NaCl; resulting concentration should be >2 mg/mL IV Administration IV push: May administer undiluted at rate of 100 mg/minute IV infusion: Dilute dose in up to 250 mL 0.9% NaCl and infuse over at least 15 minutes

Hypersensitivity to any of its components.

Hypersensitivity Reactions 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 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 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. Lactation Clinical studies showed that transfer of iron from Ferric Carboxymaltose to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that Ferric Carboxymaltose represents a risk to the breast-fed child.

Pregnancy Studies on use in pregnant women have not reported adverse developmental outcomes; however, these studies cannot establish or exclude absence of any drug-related risk during pregnancy because studies were not designed to assess for risk of major birth defects; there are risks to mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight Lactation Available published data on use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk; however, the data do not inform the full potential exposure of iron for breastfed infant; among breastfed infants, there were no adverse events reported that were considered related to ferric carboxymaltose exposure through breastmilk; there is no information on effects of ferric carboxymaltose on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy in addition to any potential adverse effects on breastfed child from drug or from underlying maternal condition

Side effects of Ferric Carboxymaltose : 1-10% Nausea (7.2%), Hypertension (3.8%), Flushing (3.6%), Decreased blood phosphorus (2.1%), Dizziness (2%), Vomiting (1.7%), Pruritus (1.5%), Rash (1.5%), Urticaria (1.5%), Wheezing (1.5%), Injection site discoloration (1.4%), Headache (1.2%), Increased alanine aminotransferase (1.1%), Dysgeusia (1.1%), Hypotension 1%) <1% Constipation (0.5%), Serious anaphylactic/anaphylactoid reactions (0.1%)

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and , Iron into the liver, spleen and Bone marrow.