Dosing and uses of Injectafer (ferric carboxymaltose)
Adult dosage forms and strengths
injectable solution
- 50mg/mL (as 750mg/15mL vial)
Iron-deficiency Anemia
Indicated for treatment of iron deficiency anemia (IDA) in adults who have intolerance or an unsatisfactory response to oral iron; also indicated for IDA in adults with nondialysis dependent chronic kidney disease
≥50 kg: 750 mg IV once, follow 7 days later with second 750 mg dose; not to exceed cumulative dose of 1500 mg per course
<50 kg: 15 mg/kg IV once, follow 7 days later with second dose; not to exceed 1500 cumulative dose per course
Administration
IV push: May administer undiluted at rate of 100 mg/minute (ie, 2 mL/minute)
IV infusion: Dilute dose (ie, 750 mg in <250 mL of sterile 0.9% NaCl to a concentrate ≥2 mg/mL) and infuse over at least 15 minutes (see IV preparation)
Discontinue infusion if extravasation occurs at administration site (brown discoloration of the extravasation site may be long lasting)
Discard any unused drug remaining after injection
Pediatric dosage forms and strengths
Safety and efficacy not established
Injectafer (ferric carboxymaltose) adverse (side) effects
1-10%
Nausea (7.2%)
Hypertension (3.8%)
Flushing (3.6%)
Decreased blood phosphorus (2.1%)
Dizziness (2%)
Vomiting (1.7%)
Pruritus (1.5%)
Rash (1.5%)
Urticaria (1.5%)
Wheezing (1.5%)
Injection site discoloration (1.4%)
Headache (1.2%)
Increased alanine aminotransferase (1.1%)
Dysgeusia (1.1%)
Hypotension 1%)
<1%
Constipation (0.5%)
Serious anaphylactic/anaphylactoid reactions (0.1%)
Postmarketing Reports
Urticaria
Dyspnea
Pruritus
Tachycardia
Erythema
Pyrexia
Chest discomfort
Chills
Angioedema
Back pain
Arthralgia
Syncope
Warnings
Contraindications
Hypersensitivity
Cautions
Hypertension reported; transient elevations in systolic BP were observed and sometimes occurred with facial flushing, dizziness, or nausea; monitor patients for signs and symptoms of hypertension following the administration of the product
Laboratory assays may overestimate serum iron and transferrin bound iron in the 24 hr following administration
Serious hypersensitivity reactions
- Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported
- Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse
- Monitor for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion
- Only administer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions
Pregnancy and lactation
Pregnancy category: C
Lactation: Distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Injectafer (ferric carboxymaltose)
Mechanism of action
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin
RBC uptake of iron released from ferric carboxymaltose ranges between 61-99%; in patients with IDA, uptake was 91-99% at day 24; in patients with renal anemia, RBC update was 61-84% at day 24
Pharmacokinetics
Maximum Fe levels: 37-333 mcg/mL (15 min to 1.21 hr post dose)
Vd: 3 L
Half-life, terminal: 7-12 hr
Excretion: Negligible renal elimination
Administration
IV Preparation
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration
Contains no preservatives
Each vial is intended for single-use only
Discard any unused drug remaining after injection
For IV infusion, dilute in up to 250 mL 0.9% NaCl; resulting concentration should be ≥2 mg/mL
IV Administration
IV push: May administer undiluted at rate of 100 mg/minute
IV infusion: Dilute dose in up to 250 mL 0.9% NaCl and infuse over at least 15 minutes
Storage
Store unopened vials at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Do not freeze
