Adult: In cases when oral Fe therapy is inadequate or impractical: Dosage is individualised based on patient body weight and Hb level. Determine the Fe needed: Hb <10 g/dL: <35 kg: 500 mg; 35-<70 kg: 1,500 mg; ≥70 kg: 2,000 mg. Hb 10-<14 g/dL: <35 kg: 500 mg; 35-<70 kg: 1,000 mg; ≥70 kg: 1,500 mg. Hb ≥14 g/dL: Regardless of body weight: 500 mg. Based on the Fe needed, appropriate dose(s) must be given taking into consideration the Max single dose of 1,000 mg Fe (15 mg Fe/kg for bolus inj or 20 mg Fe/kg for infusion). Max cumulative Fe dose: 1,000 mg weekly. As bolus inj: Fe dose >200-500 mg: Administer at a rate of 100 mg Fe/min; >500-1,000 mg: Administer over 15 minutes. As IV infusion: Fe dose: >200-500 mg: Administer over 6 minutes; >500-1,000 mg: Administer over 15 minutes. Reassess Hb level at least 4 weeks after the last administration and may repeat therapy based on recalculated Fe requirement. Alternatively, <50 kg: 15 mg/kg for 2 doses given at least 7 days apart; ≥50 kg: 750 mg for 2 doses given at least 7 days apart. Doses are given via slow inj or infusion. Max single dose: 750 mg. Max total cumulative Fe dose: 1,500 mg each course. Treatment course may be repeated if anaemia reoccurs. Dosage recommendations may vary among countries or individual products (refer to specific product guideline).
Special Patient Group
In pregnant women: Max cumulative Fe dose: Hb <9 g/dL: 1,500 mg; Hb ≥9 g/dL: 1,000 mg. Max: 1,000 mg Fe weekly.
Patients with haemodialysis-dependent chronic kidney disease (CKD): As undiluted solution: Max single dose of 200 mg Fe daily via inj into the venous limb of the dialyser. Patients with non-dialysis dependent CKD: <50 kg: 15 mg/kg for 2 doses given at least 7 days apart; ≥50 kg: 750 mg for 2 doses given at least 7 days apart. Doses are given via slow inj or infusion. Max single dose: 750 mg. Max total cumulative Fe dose: 1,500 mg each course. Treatment course may be repeated if anaemia reoccurs.
IV infusion: Dilute in max of 50 mL (doses 100-200 mg Fe), 100 mL (doses >200-500 mg Fe) or 250 mL (doses >500-1,000 mg Fe) of NaCl 0.9% solution to a final concentration of 2-5 mg Fe/mL. Recommendations for reconstitution may vary among countries or individual products. Refer to specific product guideline.
Anaemia not associated with Fe deficiency (e.g. other microcytic anaemia), Fe overload or disturbances in Fe utilisation. Hepatic impairment where Fe overload is a precipitating factor (particularly porphyria cutanea tarda).
Patients with known allergies (e.g. drug allergies), existing or history of severe asthma, eczema or other atopic allergies; immune or inflammatory conditions (e.g. SLE, rheumatoid arthritis), acute or chronic infection; risk factors for hypophosphataemia (e.g. history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, hyperparathyroidism, vitamin D deficiency, malnutrition, concomitant or prior use of drugs that affect proximal renal tubular function). Discontinue in patients with ongoing bacteraemia. Avoid extravasation. Renal and hepatic impairment. Pregnancy (2nd-3rd trimester) and lactation.
Significant: Kounis syndrome (secondary to hypersensitivity reactions), symptomatic hypophosphataemia resulting in osteomalacia and fracture; hypertension. Cardiac disorders: Tachycardia, chest discomfort. Gastrointestinal disorders: Nausea, vomiting, dysgeusia, dyspepsia, abdominal pain, constipation, diarrhoea. General disorders and administration site conditions: Inj or infusion site reactions (e.g. pain, haematoma, discolouration), pyrexia, fatigue, chills, oedema peripheral. Immune system disorders: Angioedema. Investigations: Increased ALT, AST, gamma-glutamyltransferase, blood lactate dehydrogenase, blood alkaline phosphatase. Musculoskeletal and connective tissue disorders: Myalgia, back pain, arthralgia, pain in extremity. Nervous system disorders: Dizziness, headache, paraesthesia. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Pruritus, rash, erythema, urticaria. Vascular disorders: Flushing, hypotension, syncope. Potentially Fatal: Serious hypersensitivity reactions (e.g. anaphylactic or anaphylactoid reactions).
Monitor for Hb and haematocrit, serum ferritin (assessed 2-4 weeks post-infusion course completion), Fe saturation; serum phosphate in patients receiving repeated high-dose administrations or on long-term therapy and those at risk for hypophosphataemia; vital signs (especially blood pressure). Monitor infusion site for extravasation; signs or symptoms of hypersensitivity during and for 30 minutes after each administration. In patients with CKD: Monitor serum ferritin and transferrin saturation more regularly after a treatment course.
Symptoms: May lead to Fe accumulation in storage sites resulting in haemosiderosis. Management: May give Fe chelator in case of Fe accumulation.
Decreases absorption of oral Fe; avoid initiation of oral therapy for at least 5 days after the last IV Fe administration.
May result in false elevated serum or transferrin bound Fe levels within approx 24 hours after IV administration.
Description: Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with a carbohydrate polymer that releases Fe needed to the function of Hb, myoglobin, and specific enzyme systems. It is a stable non-dextran Fe formulation which allows Fe uptake by the reticuloendothelial system without releasing free Fe. Pharmacokinetics: Absorption: Time to peak plasma concentration: 0.25-1.2 hours. Distribution: Enters breast milk (Fe). Volume of distribution: Approx 3 L. Excretion: Via urine (negligible). Terminal elimination half-life: 7-12 hours.
Store intact vials below 30°C. Do not freeze or refrigerate. Protect from light.