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Ferinject

Ferinject

ferric carboxymaltose

Manufacturer:

CSL Vifor

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ferric carboxymaltose
Indications/Uses
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. Adult & adolescent ≥14 yr 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). If total Fe need is higher, administer additional dose at min 7 days apart from 1st dose. Childn & adolescent 1-13 yr Max single dose: 15 mg Fe/kg. Max recommended cumulative dose: 750 mg Fe/wk (15 mL). If total Fe need is higher, administer additional dose at min 7 days apart from 1st dose. Adult & adolescent ≥14 yr w/ haemodialysis-dependent CKD Max daily dose: 200 mg Fe. Determination of total Fe need: Hb ≥14 g/dL or ≥8.7 mmol/L weighing 35 kg to ≥70 kg 500 mg, <35 kg 15 mg/kg; Hb 10 to <14 g/dL or 6.2 to <8.7 mmol/L weighing ≥70 kg 1,500 mg, 35 kg to <70 kg 1,000 mg, <35 kg 15 mg/kg; Hb <10 g/dL or <6.2 mmol/L weighing ≥70 kg 2,000 mg, 35 kg to <70 kg 1,500 mg, <35 kg 30 mg/kg.
Contraindications
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
Hypersensitivity reactions including serious & potentially fatal anaphylactic reactions; after previous uneventful doses of parenteral Fe complexes; which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in MI). Not to be administered by SC or IM route. Discontinue treatment immediately if hypersensitivity reactions or signs of intolerance occur during administration; in case of paravenous leakage. Discontinue treatment in patients w/ on-going bacteraemia. 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); on Na-controlled diet. Observe each patient for adverse effects for at least 30 min following each administration. Monitor serum phosphate in patients receiving multiple administrations at higher doses or long-term treatment & w/ existing risk factors for hypophosphataemia; Fe status to avoid Fe overload. Re-evaluate treatment in case of persisting hypophosphataemia. Perform benefit/risk evaluation in patients w/ chronic infection taking into account the suppression of erythropoiesis. Avoid in patients w/ hepatic dysfunction where Fe overload is precipitating factor ie, porphyria cutanea tarda. Pregnancy & lactation. Not recommended in childn 1-13 yr w/ CKD requiring haemodialysis & <1 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
Presentation/Packing
Form
Ferinject soln for inj/infusion 50 mg/mL
Packing/Price
10 mL x 1's
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