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Injectafer
ferric carboxymaltose
Black Box Warnings .
symptomatic hypophosphatemia
severe, prolonged cases associated with serious outcomes, including hospitalization, osteomalacia and fractures, requiring clinical intervention have occurred; hypophosphatemia has occurred after single and multiple doses, in patients with normal baseline phosphate levels without apparent risk factors; correct pre-existing hypophosphatemia prior to tx; check serum phosphate levels prior to repeat tx course if repeat tx course within 3mo or if hypophosphatemia risk; advise patients about hypophosphatemia risk and to report signs/symptoms of hypophosphatemia, including fatigue, muscle weakness or pain, bone and joint pain, bone fractures; consider permanently D/C tx if severe symptomatic or persistent hypophosphatemia
Adult Dosing .
Dosage forms: INJ
Special Note
- [strength clarification]
- Info: 1 mL = 50 mg elemental Fe; doses expressed as elemental Fe
iron deficiency anemia
- [<50 kg]
- Dose: 15 mg/kg/dose IV x2 doses >7 days apart; Info: for patients with non-dialysis dependent CKD or unable to take PO form; may repeat tx course if recurrent iron deficiency anemia
- [>50 kg]
- Dose: 750 mg IV x2 doses >7 days apart; Max: 1500 mg/tx course; Alt: 15 mg/kg/dose IV x1, max 1000 mg/tx course; Info: for patients with non-dialysis dependent CKD or unable to take PO form; may repeat tx course if recurrent iron deficiency anemia
iron deficiency
- [<70 kg, Hgb <10]
- Dose: 1000 mg IV x1, then 500 mg IV x1 at wk 6; Info: for patients with NYHA class II-III heart failure to improve exercise capacity; give 500 mg maintenance dose at wk 12, 24, 36 if serum ferritin <100, or serum ferritin 100-300 with transferrin saturation <20%; may repeat tx course if recurrent iron deficiency
- [<70 kg, Hgb 10-14]
- Dose: 1000 mg IV x1; Info: for patients with NYHA class II-III heart failure to improve exercise capacity; give 500 mg maintenance dose at wk 12, 24, 36 if serum ferritin <100, or serum ferritin 100-300 with transferrin saturation <20%; may repeat tx course if recurrent iron deficiency
- [<70 kg, Hgb 14.1-14.9]
- Dose: 500 mg IV x1; Info: for patients with NYHA class II-III heart failure to improve exercise capacity; give 500 mg maintenance dose at wk 12, 24, 36 if serum ferritin <100, or serum ferritin 100-300 with transferrin saturation <20%; may repeat tx course if recurrent iron deficiency
- [>70 kg, Hgb <10]
- Dose: 1000 mg IV x1, then 1000 mg IV x1 at wk 6; Info: for patients with NYHA class II-III heart failure to improve exercise capacity; give 500 mg maintenance dose at wk 12, 24, 36 if serum ferritin <100, or serum ferritin 100-300 with transferrin saturation <20%; may repeat tx course if recurrent iron deficiency
- [>70 kg, Hgb 10-14]
- Dose: 1000 mg IV x1, then 500 mg IV x1 at wk 6; Info: for patients with NYHA class II-III heart failure to improve exercise capacity; give 500 mg maintenance dose at wk 12, 24, 36 if serum ferritin <100, or serum ferritin 100-300 with transferrin saturation <20%; may repeat tx course if recurrent iron deficiency
- [>70 kg, Hgb 14.1-14.9]
- Dose: 500 mg IV x1; Info: for patients with NYHA class II-III heart failure to improve exercise capacity; give 500 mg maintenance dose at wk 12, 24, 36 if serum ferritin <100, or serum ferritin 100-300 with transferrin saturation <20%; may repeat tx course if recurrent iron deficiency
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [strength clarification]
- Info: 1 mL = 50 mg elemental Fe; doses expressed as elemental Fe
iron deficiency anemia
- [1 yo and older, <50 kg]
- Dose: 15 mg/kg/dose IV x2 doses >7 days apart; Info: for patients unable to take PO form; may repeat tx course if recurrent iron deficiency anemia
- [1 yo and older, >50 kg]
- Dose: 750 mg IV x2 doses >7 days apart; Max: 1500 mg/tx course; Alt: 15 mg/kg/dose IV x1, max 1000 mg/tx course; Info: for patients unable to take PO form; may repeat tx course if recurrent iron deficiency anemia
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hemosiderosis
- hemochromatosis
- anemia, non-iron deficiency
- hypophosphatemia
- caution: hypophosphatemia risk
Drug Interactions .
Overview
ferric carboxymaltose
iron injectable
- alters iron absorption/excretion
- heavy metal
- hypophosphatemia
- iron parenteral
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- angioedema
- hypotension
- syncope
- hypophosphatemia, severe
- osteomalacia
- fractures
Common Reactions
- nausea
- injection site reaction
- HTN
- flushing
- erythema
- hypophosphatemia
- dizziness
- vomiting
- headache
- ALT or AST incr.
- rash
- dysgeusia
- nasopharyngitis (peds patients)
- GI infection (peds patients)
- Plt decr. (peds patients)
- WBC decr. (peds patients)
Safety/Monitoring .
Monitoring Parameters
BP after each injection; signs/symptoms of hypersensitivity reaction for at least 30min after each injection; PO4 at baseline, then during tx if chronic hypophosphatemia risk; PO4 prior to repeat tx course if repeat tx course within 3mo or if hypophosphatemia risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available, though possible risk of severe hypersensitivity reaction in pregnant patients leading to fetal and neonatal bradycardia, especially in 2nd and 3rd trimesters; risk of teratogenicity and embryo-fetal death based on conflicting animal data at 0.12-0.23x recommended human dose and drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no known risk of infant harm based on limited human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for iron: reticuloendothelial system; CYP450: unknown
Excretion: for iron: unknown; Half-life: 7-12h; Info: half-life does not represent iron clearance from the body; iron elimination is difficult, accumulation is toxic
Subclass: Iron Homeostasis ; Minerals
Mechanism of Action
for iron: provides an essential component in hemoglobin, myoglobin, and various enzymes
Formulary .
No Formulary Selected
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