(FER ik kar box ee MAWL tose)
- Iron Carboxymaltose
- Iron Dextri-Maltose
- VIT 45
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injectafer: 750 mg/15 mL (15 mL)
Brand Names: U.S.
- Iron Salt
Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron necessary to the function of hemoglobin, myoglobin, and specific enzyme systems; allows transport of oxygen via hemoglobin. Ferric carboxymaltose is a non-dextran formulation that allows for iron uptake (into reticuloendothelial system) without the release of free iron (Szczech, 2010).
Vd: ~3 L
Onset of Action
Maximum iron levels (37-333 mcg/mL): 0.25-1.2 hours
Use: Labeled Indications
Iron-deficiency anemia (IDA): Treatment of IDA in adults with intolerance to oral iron or unsatisfactory response to oral iron; treatment of IDA in adults with nondialysis-dependent chronic kidney disease (ND-CKD)
Hypersensitivity to ferric carboxymaltose or any component of the formulation
Note: Dose expressed as elemental iron
Iron-deficiency anemia (IDA): IV:
<50 kg: 15 mg/kg elemental iron on day 1; repeat dose after at least 7 days (maximum: 1500 mg elemental iron per course). May repeat course of therapy if anemia reoccurs.
≥50 kg: 750 mg on day 1; repeat dose after at least 7 days (maximum: 1500 mg per course). May repeat course if anemia reoccurs.
Refer to adult dosing.
Dosing: Renal Impairment
Chronic kidney disease, nondialysis dependent: No dosage adjustment necessary (indicated for use in nondialysis CKD)
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling.
May administer undiluted (for IV push) or diluted (for infusion). When administering as an IV infusion, dilute up to 750 mg in a maximum of 250 mL of 0.9% sodium chloride injection to a concentration of 2-4 mg/mL; concentration should be ≥2 mg/mL. Discard unused portion of vial (single-use).
Administer as slow IV push (undiluted) at a rate of ~100 mg/minute or by IV infusion (diluted to ≥ 2 mg/mL) over at least 15 minutes.
Avoid extravasation (may cause persistent discoloration). Monitor; if extravasation occurs, discontinue administration at that site.
Stable in NS
Store intact vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F); do not freeze. Solutions diluted in 0.9% sodium chloride at concentrations of 2-4 mg/mL are stable for 72 hours at room temperature.
Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Avoid combination
Serum or transferrin bound iron levels may be falsely elevated if assessed within 24 hours of ferric carboxymaltose administration.
>10%: Endocrine & metabolic: Decreased serum phosphate (27%; <2 mg/dL [0.65 mmol/L]; transient)
1% to 10%:
Cardiovascular: Increased blood pressure (6%; transient, systolic), flushing (4%), hypertension (4%), hypotension
Central nervous system: Dizziness (2%), headache (1%)
Dermatologic: Skin discoloration at injection site (1%)
Endocrine & metabolic: Hypophosphatemia (2%)
Gastrointestinal: Nausea (7%), vomiting (2%), constipation (1%), dysgeusia (1%)
Hepatic Increased serum ALT (1%)
<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, hypersensitivity, syncope, tachycardia
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions (some life-threatening and fatal) have been reported. Monitor during and for ≥30 minutes after administration and until clinically stable. Signs/symptoms of serious hypersensitivity reaction include shock, hypotension, loss of consciousness, and/or collapse. Equipment for resuscitation, medication, and trained personnel experienced in handling emergencies should be immediately available during infusion.
• Hypertension: Transient elevations in systolic blood pressure (sometimes with facial flushing, dizziness, or nausea) were observed in studies; usually occurred immediately after dosing and resolved within 30 minutes. Monitor blood pressure following infusion.
• Laboratory alterations: Lab assays may overestimate serum iron and transferrin bound irons for ~24 hours after infusion.
Hemoglobin and hematocrit, serum ferritin, iron saturation; vital signs (including blood pressure); signs and symptoms of hypersensitivity (monitor for ≥30 minutes following the end of administration and until clinically stable); monitor infusion site for extravasation.
NKF KDOQI guidelines (2006) recommend monitoring iron status every 1-3 months, with more frequent monitoring after course of IV iron therapy.
Pregnancy Risk Factor
Adverse events were observed in some animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience injection site pain. Have patient report immediately to prescriber shortness of breath, severe dizziness, passing out, flushing, muscle pain, muscle weakness, injection site irritation, severe nausea, severe vomiting, or severe headache (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about ferric carboxymaltose
- Other brands: Injectafer