Ferinject

Ferinject

ferric carboxymaltose

Manufacturer:

Vifor

Distributor:

Zuellig
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
Adult & adolescent ≥14 yr Should not exceed 15 mg Fe/kg IV inj or 20 mg Fe/kg IV infusion. Max recommended cumulative dose: 1,000 mg Fe/wk (20 mL). If total Fe need is higher, then administration of additional dose should be min 7 days apart from 1st dose. Patient w/ haemodialysis-dependent CKD Single max daily dose: 200 mg. Childn & adolescent 1-13 yr Should not exceed 15 mg Fe/kg. Max recommended cumulative dose: 750 mg Fe/wk (15 mL). If total Fe need is higher, then administration of additional dose should be min 7 days apart from 1st dose. IV inj (undiluted) Rate: >10-20 mL (>500-1,000 mg Fe) for at least 15 min; >4-10 mL (>200-500 mg Fe) for at least 100 mg Fe/min; 2-4 mL (100-200 mg Fe) w/ no minimal prescribed time. IV infusion Conc: Not <2 mg Fe/mL (not including vol of ferric carboxymaltose dispersion). Rate: >10-20 mL (>500-1,000 mg Fe) diluted soln for at least 15 min infusion time; >4-10 mL (>200-500 mg Fe) diluted soln for at least 6 min infusion time; 2-4 mL (100-200 mg Fe) diluted soln w/ no minimal prescribed infusion time.
Contraindications
Hypersensitivity to ferric carboxymaltose or to other parenteral Fe products. Anaemia not attributed to Fe deficiency eg, other microcytic anaemia. Evidence of Fe overload or disturbances in the utilization of Fe.
Special Precautions
Do not administer by SC or IM route. Can cause hypersensitivity reactions including serious & potentially fatal anaphylactic reactions; increased risk in patients w/ known allergies including drug allergies, w/ history of severe asthma, eczema or other atopic allergy & in patients w/ immune or inflammatory conditions (eg, SLE, RA). Observe for at least 30 min following each administration; stop immediately if hypersensitivity reactions or signs of intolerance occur. Monitor serum phosphate in patients receiving multiple administrations at higher doses or long-term treatment & those w/ existing risk factors for hypophosphataemia. Reports of symptomatic hypophosphataemia leading to osteomalacia & fracture requiring clinical intervention. Re-evaluate treatment in case of persisting hypophosphataemia. Parenteral Fe should only be administered in patients w/ liver dysfunction after careful benefit/risk assessment. Avoid in patients w/ hepatic dysfunction where Fe overload is a precipitating factor, in particular porphyria cutanea tarda; careful monitoring of Fe status is recommended. Caution in acute or chronic infection, asthma, eczema or atopic allergies. Discontinue in patients w/ ongoing bacteremia. Avoid paravenous leakage. Contains Na. Should not be used during pregnancy unless clearly necessary. Not recommended in childn <1 yr; childn 1-13 yr w/ CKD requiring haemodialysis.
Adverse Reactions
Hypophosphataemia; headache, dizziness; flushing, HTN; nausea; inj/infusion site reactions.
Drug Interactions
Reduced absorption of oral Fe in concomitant use w/ parenteral Fe prep.
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 50 mg/mL
Packing/Price
10 mL x 1's;10 mL x 2 × 1's;10 mL x 5 × 1's;2 mL x 1's;2 mL x 5 × 1's