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Ferric carboxymaltose: Drug information

Ferric carboxymaltose: Drug information
(For additional information see "Ferric carboxymaltose: Patient drug information" and see "Ferric carboxymaltose: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Injectafer
Pharmacologic Category
  • Iron Preparations
Dosing: Adult

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

Chemotherapy-associated anemia (off-label use): IV: 15 mg/kg (maximum dose: 750 mg) once weekly for 2 doses (Ref).

Iron-deficiency anemia, treatment

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

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

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.

Ferric Carboxymaltose IV Dosing for Iron Deficiency in Patients With Heart Failurea,b

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.

Perioperative iron deficiency anemia

Perioperative iron deficiency anemia (off-label use):

Note: Optimal dose has not been established; example regimen is provided below (Ref).

IV: 15 to 20 mg/kg (maximum dose: 1 g) once on postoperative day 1 (Ref).

Restless legs syndrome

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.

Dosing: Kidney Impairment: Adult

Chronic kidney disease, nondialysis dependent: No dosage adjustment necessary (indicated for use in nondialysis CKD)

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ferric carboxymaltose: Pediatric drug information")

Dosage guidance:

Dosing: Dose is expressed in milligrams of elemental iron.

Iron-deficiency anemia, treatment

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

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.

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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

Contraindications

Hypersensitivity to ferric carboxymaltose or any component of the formulation

Warnings/Precautions

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.

Dosage Forms Considerations

Each mL of Injectafer contains 50 mg of elemental iron

Dosage Forms: US

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)

Generic Equivalent Available: US

No

Pricing: US

Solution (Injectafer Intravenous)

100 mg/2 mL (per mL): $115.68

750 mg/15 mL (per mL): $115.67

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

Iron-deficiency anemia: Treatment of iron-deficiency anemia (IDA) in adults and pediatric patients ≥1 year of age with intolerance to oral iron or unsatisfactory response to oral iron; treatment of IDA in adults with nondialysis-dependent chronic kidney disease (ND-CKD).

Iron deficiency in patients with heart failure: Treatment of iron deficiency with or without anemia in adults with New York Heart Association class II or III heart failure to improve exercise capacity.

Use: Off-Label: Adult

Chemotherapy-associated anemia; Iron-deficiency anemia in inflammatory bowel disease; Perioperative iron deficiency anemia; Restless legs syndrome

Medication Safety Issues
Sound-alike/look-alike issues:

Ferric carboxymaltose may be confused with ferric gluconate, ferumoxytol

Metabolism/Transport Effects

None known.

Drug Interactions

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

Pregnancy Considerations

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).

Breastfeeding Considerations

Iron is present in breast milk.

Endogenous iron concentrations in breast milk vary by postpartum age and are lower than concentrations in the maternal plasma (Dorea 2000; Emmett 1997). Breast milk concentrations of iron are maintained in lactating patients with mild to moderate iron-deficiency anemia (IDA), but concentrations decrease if IDA is moderate to severe (El-Farrash 2012) or severe (Kumar 2008).

Iron concentrations in breast milk increase following maternal administration of ferric carboxymaltose; highest concentrations were observed 24 hours following administration to 11 postpartum patients with IDA (Breymann 2008).

Ferric carboxymaltose has been evaluated in multiple studies for the treatment of postpartum IDA (Sultan 2019; Vanobberghen 2021). Adverse events in breastfed infants were limited and similar to those observed following maternal use of an oral iron preparation (Breymann 2008). In a study of 57 patients with moderate to severe anemia, a single postpartum dose of ferric carboxymaltose was found to treat anemia and replenish iron reserves for up to 6 months (Kaur 2021).

Iron deficiency and IDA are associated with adverse effects in postpartum patients (eg, altered cognition, depression, fatigue) that may influence interactions with the infant. Iron supplementation in the postpartum patient should be initiated as soon as possible following delivery when gestational anemia is a concern (WHO 2016). Parenteral iron therapy may be used in postpartum patients with uncorrected anemia at delivery who cannot tolerate, do not respond to, or are noncompliant with oral iron therapy, or the severity of anemia requires prompt management (BSH [Pavord 2020]).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Hemoglobin and hematocrit, serum ferritin, transferrin saturation, serum phosphate (in patients at risk for hypophosphatemia who require a repeat course of treatment); vital signs (including blood pressure); monitor for signs/symptoms of hypersensitivity (monitor for ≥30 minutes following the end of administration and until clinically stable); monitor infusion site for extravasation.

Chronic kidney disease: Monitor transferrin saturation and ferritin more frequently following a course of IV iron (KDIGO 2013).

Chemotherapy-associated anemia (off-label use): Iron, total iron-binding capacity, transferrin saturation, or ferritin levels at baseline and periodically (Rizzo 2010).

Iron deficient patients should have serum ferritin assessed 2 to 4 weeks after infusion course is completed; if serum ferritin >50 to 100 ng/mL is not achieved, then another iron dose should be administered (DeLoughery 2017).

Reference Range

Anemia:

Hemoglobin, whole blood:

Female: 12 to16 g/dL (SI: 120 to 160 g/L) (ABIM 2023).

Male: 13 to 18 g/dL (SI: 130 to 180 g/L) (ABIM 2023; WHO 2011).

Iron deficiency (ABIM 2023):

Ferritin, serum: Note: Ferritin is an acute phase reactant; levels may be elevated in the presence of inflammation or infection which is independent of iron status (WHO 2020).

Female: 24 to 307 ng/mL (SI: 53.9 to 689.8 picomole/L).

Male: 24 to 336 ng/mL (SI: 53.9 to 755 picomole/L).

Iron, serum: 50 to 150 mcg/dL (SI: 9 to 26.9 micromole/L).

Total iron binding capacity, serum: 250 to 310 mcg/dL (SI: 44.8 to 55.5 micromole/L).

Transferrin saturation: 20% to 50%.

Transferrin, serum: 200 to 400 mg/dL (SI: 24.6 to 49.2 micromole/L).

Chronic kidney disease-associated anemia: To achieve and maintain target hemoglobin for patients with nondialysis-dependent chronic kidney disease, patients with a transferrin saturation (TSAT) ≤30% and a serum ferritin level ≤500 ng/mL (SI: 1,123.5 picomole/L) will often respond to iron supplementation (Gutiérrez 2021; KDIGO 2012).

Mechanism of Action

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).

Pharmacokinetics (Adult Data Unless Noted)

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).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Ferinject;
  • (AR) Argentina: Ferinject;
  • (AT) Austria: Ferinject;
  • (AU) Australia: Ferinject;
  • (BD) Bangladesh: Fematos | Ferinject | Ferintus | Xefer;
  • (BG) Bulgaria: Ferinject;
  • (BR) Brazil: Ferinject;
  • (CH) Switzerland: Ferinject;
  • (CL) Chile: Ferinject;
  • (CO) Colombia: Ferinject;
  • (CZ) Czech Republic: Ferinject;
  • (DE) Germany: Ferinject;
  • (DO) Dominican Republic: Ferinject;
  • (EC) Ecuador: Ferinject;
  • (EE) Estonia: Ferinject;
  • (ES) Spain: Ferinject;
  • (ET) Ethiopia: Haem;
  • (FI) Finland: Ferinject;
  • (FR) France: Ferinject;
  • (GB) United Kingdom: Ferinject;
  • (GR) Greece: Ferinject;
  • (HK) Hong Kong: Ferinject;
  • (HR) Croatia: Ferinject;
  • (HU) Hungary: Ferinject;
  • (ID) Indonesia: Ferinject;
  • (IE) Ireland: Ferinject;
  • (IN) India: Bdcarboxy | Carbinject | Encicarb | Fcmalt | Ferinject | Hosit fcm | Inronx | Paldela | Raricap fcm;
  • (IT) Italy: Ferinject;
  • (JO) Jordan: Ferinject;
  • (JP) Japan: Ferinject;
  • (KR) Korea, Republic of: Ferinject;
  • (KW) Kuwait: Ferinject;
  • (LB) Lebanon: Ferinject;
  • (LT) Lithuania: Ferinject;
  • (LV) Latvia: Ferinject;
  • (MA) Morocco: Ferinject;
  • (MY) Malaysia: Ferinject;
  • (NL) Netherlands: Ferinject;
  • (NO) Norway: Ferinject;
  • (NZ) New Zealand: Ferinject;
  • (PE) Peru: Ferinject;
  • (PH) Philippines: Ferinject;
  • (PK) Pakistan: Boferin | Ferinject;
  • (PL) Poland: Ferinject;
  • (PR) Puerto Rico: Injectafer;
  • (PT) Portugal: Ferinject | Inferject;
  • (QA) Qatar: Ferinject;
  • (RO) Romania: Ferinject;
  • (RU) Russian Federation: Feringect | Ferinject;
  • (SA) Saudi Arabia: Ferinject;
  • (SE) Sweden: Ferinject;
  • (SG) Singapore: Ferinject;
  • (SK) Slovakia: Ferinject;
  • (TR) Turkey: Ferinject;
  • (UA) Ukraine: Ferrinject;
  • (UY) Uruguay: Ferinject;
  • (ZA) South Africa: Ferinject
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  15. DelRosso LM, Picchietti DL, Ferri R. Comparison between oral ferrous sulfate and intravenous ferric carboxymaltose in children with restless sleep disorder. Sleep. 2021;44(2):zsaa155. doi:10.1093/sleep/zsaa155 [PubMed 32840615]
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  21. Ferinject (ferric carboxymaltose) [product information]. Melbourne, Australia: Vifor Pharma Pty Ltd; September 2021.
  22. Ferinject (ferric carboxymaltose) [summary of product characteristics]. Paris, France: Vifor France; June 2021.
  23. Ferinject (ferric carboxymaltose) [summary of product characteristics]. Surrey, UK: Vifor Pharma UK Limited; July 2021.
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