Monofer

Fe (III) isomaltoside 1000

Treatment of Fe deficiency when oral Fe prep are ineffective or cannot be used, or where there is a clinical need to deliver Fe rapidly.

Determine individual Fe need, calculate & administer Fe dose, then reassess Hb level no earlier than 4 wk post final administration. Recalculate Fe need if further Fe repletion is required. Max total dose per wk: 20 mg Fe/kg. IV bolus inj Administer ≤500 mg Fe, 1-3 times a wk, at an administration rate of up to 250 mg Fe/min. Max: 500 mg Fe. IV infusion Administer ≤1,000 mg Fe in >15 min. Administer >1,000 mg Fe in ≥30 min. Max: 20 mg Fe/kg. If Fe need exceeds 20 mg Fe/kg, split dose in 2 administrations w/ an interval of at least 1 wk. Inj into dialyser Administer during haemodialysis session directly into venous limb of dialyser under the same procedures for IV bolus inj. Patient w/ Hb ≥10 g/dL (or ≥6.2 mmol/L) & weighing ≥70 kg 1,500 mg elemental Fe, 50 to <70 kg 1,000 mg elemental Fe, <50 kg 500 mg elemental Fe. Patient w/ Hb <10 g/dL (or <6.2 mmol/L) & weighing ≥70 kg 2,000 mg elemental Fe, 50 to <70 kg 1,500 mg elemental Fe, <50 kg 500 mg elemental Fe.

Hypersensitivity to Fe (III) isomaltoside 1000 or other parenteral Fe products. Non-Fe deficiency anaemia (eg, haemolytic anaemia). Fe overload or disturbances in Fe utilisation (eg, haemochromatosis, haemosiderosis). Decompensated liver disease.

Carefully monitor for signs & symptoms of hypersensitivity reactions during & following each administration. Observe for adverse effects for at least 30 min following each inj. Immediately stop treatment if hypersensitivity reactions or signs of intolerance occur during administration. Increased risk of hypersensitivity reactions in patients w/ known allergies including drug allergies; history of severe asthma, eczema or other atopic allergy; immune or inflammatory conditions (eg, SLE, RA). Avoid paravenous leakage. Immediately stop administration in case of paravenous leakage. Use w/ caution in case of acute or chronic infection. Do not use in patients w/ ongoing bacteraemia. Should only be administered after careful benefit/risk assessment in patients w/ compensated liver dysfunction. Avoid in patients w/ hepatic dysfunction (ALT &/or AST >3x ULN) where Fe overload is a precipitating factor, in particular porphyria cutanea tarda. Carefully evaluate risk/benefit before use during pregnancy. Confine treatment to 2nd & 3rd trimesters of pregnancy if benefit outweighs potential risk for both mother & foetus. Carefully monitor unborn baby during IV administration to pregnant women. Not recommended in childn & adolescents <18 yr.

Nausea; rash; inj site reactions (erythema, swelling, burning, pain, bruising, discolouration, extravasation, irritation).

Reduced absorption of oral Fe. Reports of large doses (≥5 mL) giving brown colour to serum from blood sample drawn 4 hr after administration. Falsely elevated values of serum bilirubin & falsely decreased values of serum Ca.

Vitamins & Minerals (Pre & Post Natal) / Antianemics

B03AC - Iron, parenteral preparations ; Used in the treatment of anemia

P₁S₁S₃