Dosage guidance:
Dosing: Dose is expressed in milligrams of elemental iron.
Iron-deficiency anemia, treatment:
Children and Adolescents:
Two-dose regimen: IV: 15 mg/kg/dose for 2 doses separated by ≥7 days; maximum dose: 750 mg/dose (Ref).
Single- dose regimen: Limited data available: IV: 15 to 20 mg/kg/dose as a single dose; maximum dose: 1,000 mg/dose (Ref). Dosing based on calculated iron deficit using the Ganzoni equation has also been reported; reported doses range from 10 to 32 mg/kg/dose with maximum single doses of 1,000 mg/dose (Ref).
Restless sleep disorder: Very limited data available: Children ≥5 years and Adolescents: IV: 15 mg/kg as a single dose; maximum dose: 750 mg/dose. Dosing based on a single study comparing IV ferric carboxymaltose with oral ferrous sulfate (n=30; 15 patients received ferric carboxymaltose); the ferric carboxymaltose group experienced more improvement and fewer adverse effects than the oral ferrous sulfate group (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. Based on experience in adults, no adjustments are likely needed in nondialysis-dependent patients with chronic kidney disease.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Ferric carboxymaltose: Drug information")
Note: Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, need for rapid repletion, chronic kidney disease, active inflammatory bowel disease, cancer, chronic or extensive blood loss) (Ref). Dosage expression: Dose is expressed in mg of elemental iron. Test dose: A test dose is not required.
Chemotherapy-associated anemia (off-label use): IV: 15 mg/kg (maximum dose: 750 mg) once weekly for 2 doses (Ref).
Iron-deficiency anemia , treatment:
≥50 kg:
Two-dose regimen: IV: 750 mg once; after ≥7 days, administer a second dose of 750 mg once; maximum dose: 1.5 g per treatment course.
Single-dose regimen: IV: 15 mg/kg as a single dose; maximum dose: 1 g.
<50 kg: IV: 15 mg/kg once; after ≥7 days, administer a second dose of 15 mg/kg once.
Iron-deficiency anemia in inflammatory bowel disease (off-label use): IV: 500 to 1,000 mg/dose on day 1 (and if needed based on hemoglobin values, days 8 and 15); patients <67 kg received a maximum of 500 mg per infusion (Ref).
Iron deficiency in patients with heart failure: Note: Iron deficiency is defined as a serum ferritin level <100 mcg/L or a serum ferritin level of 100 to 300 mcg/L with transferrin saturation <20% with or without anemia. There are no data for dosing if hemoglobin is ≥15 g/dL.
Weight <70 kg |
Weight ≥70 kg | |||||
---|---|---|---|---|---|---|
Hb <10 g/dL |
Hb 10 to 14 g/dL |
Hb >14 to <15 g/dL |
Hb <10 g/dL |
Hb 10 to 14 g/dL |
Hb >14 to <15 g/dL | |
a There are no available data for dosing beyond 36 weeks or in patients with a hemoglobin of ≥15 g/dL. | ||||||
b Hb = hemoglobin; ID = iron deficient. | ||||||
Day 1 |
1 g |
1 g |
500 mg |
1 g |
1 g |
500 mg |
Week 6 |
500 mg |
No dose |
No dose |
1 g |
500 mg |
No dose |
Recheck iron studies, if iron deficiency persists at weeks 12, 24, or 36 then redose as needed. | ||||||
Week 12 |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
Week 24 |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
Week 36 |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
500 mg, only if ID |
Note: The Ganzoni equation has been recommended as an alternative method to calculate total iron deficit and guide dosing. Replete the iron deficit with 500 mg to 1 g dose(s) every ≥7 days as needed (eg, if iron deficit is 1.5 g, administer 750 mg once and 750 mg again in ≥7 days for a total of 1.5 g). Recheck iron studies every 3 to 6 months and replete again if iron deficiency persists (Ref).
Iron deficit (mg) = weight (kg)a × (target hemoglobin of 15 g/dL − actual hemoglobin in g/dL) × 2.4 + 500 mg
a Actual body weight; for patients with obesity, use ideal body weight.
Restless legs syndrome (off-label use):
Note: For use as an alternative to oral iron repletion for patients with malabsorption, intolerance or lack of response to oral therapy, or need for rapid response to therapy; not recommended for initiation of therapy in patients with serum ferritin >100 mcg/L or transferrin saturation (TSAT) ≥45% (Ref).
IV: 1 g as a single dose. May repeat at least 12 weeks after initial infusion based on initial response, recurrence of restless legs syndrome symptoms, and if serum ferritin <300 mcg/L and TSAT <45% (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Chronic kidney disease, nondialysis dependent: No dosage adjustment necessary (indicated for use in nondialysis CKD)
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults, unless otherwise noted.
>10%: Endocrine & metabolic: Hypophosphatemia (children, adolescents: 13%; adults: 1% to 2%)
1% to 10%:
Cardiovascular: Flushing (children, adolescents, adults: ≤4%), hypertension (1% to 4%), hypotension (≤1%), increased systolic blood pressure (6%)
Dermatologic: Erythema of skin (≤3%), skin rash (children, adolescents: 8%; adults: 1%)
Gastrointestinal: Dysgeusia (1%), gastrointestinal infection (children, adolescents: 3%), nausea (1% to 7%), vomiting (children, adolescents, adults: ≤5%)
Hematologic & oncologic: Decreased platelet count (children, adolescents: 3%), decreased white blood cell count (children, adolescents: 3%)
Hepatic: Increased liver enzymes (children, adolescents, adults: 1% to 3%)
Local: Injection-site reaction (children, adolescents, adults: 3% to 8%; including bleeding at injection site, bruising at injection site, discomfort at injection site, erythema at injection site, hematoma at injection site, injection-site numbness [hypoesthesia], injection-site pruritus, irritation at injection site, pain at injection site, rash at injection site, skin discoloration at injection site [≤1%], and swelling at injection site)
Nervous system: Dizziness (1% to 2%), headache (children, adolescents: 5%; adults: 1%)
Respiratory: Nasopharyngitis (children, adolescents: 3%)
<1%:
Gastrointestinal: Abdominal pain, constipation, diarrhea
Hepatic: Increased gamma-glutamyl transferase
Hypersensitivity: Anaphylaxis, nonimmune anaphylaxis
Nervous system: Paresthesia
Respiratory: Sneezing
Postmarketing:
Cardiovascular: Chest discomfort, syncope, tachycardia
Dermatologic: Pruritus, urticaria
Hypersensitivity: Angioedema, hypersensitivity reaction
Nervous system: Chills
Neuromuscular & skeletal: Arthralgia, back pain, osteomalacia (hypophosphatemic)
Respiratory: Dyspnea
Miscellaneous: Fever
Hypersensitivity to ferric carboxymaltose or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity: Serious hypersensitivity reactions, including anaphylactic-type reactions (some life-threatening and fatal) have been reported. 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.
• Hypophosphatemia: Symptomatic hypophosphatemia, with serious outcomes (eg, fractures, osteomalacia), has been reported. Most cases occurred after repeated exposure in patients without a history of renal impairment and resolved within 3 months; however, may occur after 1 dose. Risk factors may include a history of GI disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, use (current or prior) of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, and malnutrition. Correct hypophosphatemia prior to prescribing initial or repeat treatment.
Other warnings/precautions:
• Laboratory alterations: Lab assays may overestimate serum iron and transferrin bound irons for ~24 hours after infusion.
Each mL of Injectafer contains 50 mg of elemental iron
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Injectafer: 100 mg/2 mL (2 mL); 750 mg/15 mL (15 mL)
No
Solution (Injectafer Intravenous)
100 mg/2 mL (per mL): $115.68
750 mg/15 mL (per mL): $115.67
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Parenteral: IV: In prospective and retrospective pediatric studies, doses were infused over 15 to 30 minutes (Ref). Administer diluted solution over ≥15 minutes (Ref); maximum infusion time of 60 minutes has been reported (Ref). For doses of 750 mg, may administer undiluted as a slow IV push at a rate of ~100 mg/minute; for doses of 1,000 mg, administer over 15 minutes. Avoid extravasation (may cause persistent discoloration at the extravasation site). If extravasation occurs, discontinue administration at that site.
IV: Administer as slow IV push (undiluted) at a rate of ~100 mg/minute (doses ≤750 mg) or over 15 minutes (1 g dose). May also administer as an IV infusion (diluted) over at least 15 minutes.
Avoid extravasation (may cause persistent discoloration at the extravasation site). Monitor; if extravasation occurs, discontinue administration at that site.
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 to 4 mg/mL are stable for 72 hours at room temperature.
Treatment of iron deficiency anemia in patients with intolerance or unsatisfactory response to oral iron (FDA approved in ages ≥1 year and adults); treatment of iron deficiency anemia in patients with nondialysis-dependent chronic kidney disease (FDA approved in adults); treatment of iron deficiency with or without anemia in patients with New York Heart Association class II or III heart failure to improve exercise capacity (FDA approved in adults).
Ferric carboxymaltose may be confused with ferric gluconate, ferumoxytol
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
Ferric carboxymaltose was not found to cross the placenta in an in vitro placental perfusion study (Malek 2010). Iron transfer to the fetus is regulated by the placenta (BSH [Pavord 2020]; NAS 2020).
There is a risk of adverse maternal reactions (eg, anaphylaxis, hypotension, shock) following use of parenteral iron which may result in fetal bradycardia, especially during the second and third trimesters. Although the risk is rare, immediate treatment for anaphylactoid and/or hypersensitivity reactions should be available (BSH [Pavord 2020]).
Maternal iron requirements increase during pregnancy. Untreated iron deficiency and iron-deficiency anemia (IDA) in pregnant patients are associated with adverse pregnancy outcomes, including low birth weight, preterm birth, and increased perinatal mortality (ACOG 2021; BSH [Pavord 2020]). Maternal iron deficiency is also associated with fatigue, increased risk of postpartum depression, and possibly postpartum hemorrhage (BSH [Pavord 2020]).
Oral and parenteral iron are effective at replacing iron stores in pregnant patients (ACOG 2021). Most studies note iron therapy improves maternal hematologic parameters; however, data related to clinical outcomes in the mother and neonate are limited (FIGO 2019; NAS 2020; USPSTF [Siu 2015]). Parenteral iron therapy may be used in pregnant patients who cannot tolerate or respond to oral iron, when iron deficiency occurs later in pregnancy, or when malabsorption is present (ACOG 2021; BSH [Pavord 2020]).
Ferric carboxymaltose has been evaluated for the treatment of IDA during pregnancy (Breymann 2017; Froessler 2018; Khalafallah 2018; Oskovi-Kaplan 2021; Qassim 2018; Rogozińska 2021; Shim 2018; Shin 2021; Wani 2019). Based on available data, adverse developmental outcomes have not been reported following maternal use of ferric carboxymaltose in pregnancy. However, due to limited safety data in early pregnancy, use of intravenous iron is generally not started until the second or third trimester (ACOG 2021; BSH [Pavord 2020]; FIGO 2019).
IV iron may be considered for the treatment of restless legs syndrome in pregnant patients with serum ferritin <30 ng/mL who have failed oral iron; use of IV iron should be avoided during the first trimester (Picchietti 2015; Schneider 2015).
Hemoglobin and hematocrit, serum ferritin, transferrin saturation; serum phosphorous (before repeat treatment in all patients and may consider monitoring at baseline [within 4 weeks] and post-infusion [within 6 weeks] in all patients) (Kirk 2021; manufacturer's labeling); vital signs and signs and symptoms of hypersensitivity (monitor during infusion, for ≥30 minutes following the end of administration, and until clinically stable); signs and symptoms of high blood pressure (following administration); monitor infusion site for extravasation.
Serum iron (AAP [Kleinman 2019]):
≤6 weeks: 100 to 250 mcg/dL.
7 weeks to 11 months: 40 to 100 mcg/dL.
1 to 10 years: 50 to 120 mcg/dL.
≥11 years:
Female: 30 to 160 mcg/dL.
Male: 50 to 170 mcg/dL.
Total iron binding capacity (AAP [Kleinman 2019]):
≤2 months: 59 to 175 mcg/dL.
3 months to 17 years: 250 to 400 mcg/dL.
≥18 years: 240 to 450 mcg/dL.
Chronic kidney disease targets for iron therapy (KDIGO 2013):
Transferrin saturation (TSAT): >20%.
Serum ferritin: >100 ng/mL.
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).
Distribution: Vd: ~3 L.
Half-life elimination:
Children and Adolescents: ~9.7 hours.
Adults: 7 to 12 hours.
Time to peak:
Children and Adolescents: Median: 7 minutes.
Adults: 0.25 to 1.21 hours following administration.
Excretion: Urine (negligible).
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