ferric carboxymaltose


IDT Biologika


Zuellig Pharma
Concise Prescribing Info
Ferric carboxymaltose
Fe deficiency when oral Fe prep are ineffective or cannot be used, or there is clinical need to deliver Fe rapidly.
Dosage/Direction for Use
IV Administer by inj or infusion, or during hemodialysis session undiluted directly into venous limb of dialyser. Max single dose: 15 mg Fe/kg for IV inj or 20 mg Fe/kg for IV infusion. Max recommended cumulative dose: 1,000 mg Fe/wk (20 mL). Hb ≥14 g/dL & ≥8.7 mmol/L weighing ≥70 kg, 35 to <70 kg, <35 kg 500 mg. Hb 10 to <14 g/dL & 6.2 to <8.7 mmol/L weighing ≥70 kg 1,500 mg, 35 to <70 kg 1,000 mg, <35 kg 500 mg. Hb <10 g/dL & <6.2 mmol/L weighing ≥70 kg 2,000 mg, 35 kg to <70 kg 1,500 mg, <35 kg 500 mg. Haemodialysis-dependent CKD Single max daily dose: 200 mg Fe.
Hypersensitivity to ferric carboxymaltose & other parenteral Fe products. Anaemia not attributed to Fe deficiency eg, other microcytic anaemia. Evidence of Fe overload or disturbances in Fe utilisation.
Special Precautions
Stop treatment if hypersensitivity reactions or signs of intolerance occur; in patients w/ on-going bacteraemia; in case of paravenous leakage. Not to be administered by SC or IM route. Hypersensitivity reactions including serious & potentially fatal anaphylactic/anaphylactoid reactions; after previously uneventful doses of parenteral Fe complexes; risk of progression to Kounis syndrome. Symptomatic hypophosphataemia leading to osteomalacia & fractures requiring clinical intervention including surgery; worsening fatigue w/ myalgias or bone pain. Acute or chronic infection, asthma, eczema or atopic allergies. Patients w/ known allergies including drug allergies; history of severe asthma, eczema or other atopic allergy; immune or inflammatory conditions (eg, SLE, RA). Patients on Na-controlled diet. Monitor serum phosphate in patients receiving multiple administrations at higher doses or long-term treatment & w/ risk factors for hypophosphataemia; Fe status to avoid Fe overload. Avoid in patients w/ hepatic dysfunction where Fe overload is precipitating factor, ie, porphyria cutanea tarda. Pregnancy & lactation. Not recommended in childn <14 yr.
Adverse Reactions
Hypophosphataemia; headache, dizziness; flushing, HTN; nausea; inj/infusion site reactions.
Drug Interactions
MIMS Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Ferinject soln for inj/infusion 50 mg/mL
10 mL x 1's
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