Medically reviewed by Drugs.com. Last updated on Apr 22, 2020.
(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 Preparations
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
Time to Peak
0.25 to 1.2 hours following administration
7 to 12 hours
Use: Labeled Indications
Iron deficiency anemia: Treatment of iron deficiency anemia (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)
Off Label Uses
Abdominal surgery, major (perioperative anemia management)
Data from a randomized, controlled trial comparing ferric carboxymaltose therapy to usual perioperative care (eg, no treatment, continued observation, oral iron recommendations, and allogeneic blood transfusion) in patients with iron deficiency anemia scheduled for abdominal surgery supports the use of ferric carboxymaltose in perioperative patients. Results showed a reduced need for blood transfusion in the perioperative period, a shorter hospital stay, enhanced restoration of iron stores, and higher mean hemoglobin concentration 4 weeks after surgery in those receiving intravenous iron [Froessler 2016].
Data from a prospective observational study in adult patients with active malignancy and absolute or functional iron deficiency suggests ferric carboxymaltose (with or without concomitant erythropoiesis-stimulating agents [ESAs]) may be utilized to correct anemia [Steinmetz 2013].
Iron deficiency anemia in inflammatory bowel disease
Data from a multicenter, randomized, controlled, open-label trial supports the use of ferric carboxymaltose in patients with inflammatory bowel disease (IBD) and iron deficiency anemia (Evstatiev 2011). Clinical experience also supports the use of ferric carboxymaltose in this patient population. Intravenous iron therapy is indicated when IBD is active, anemia is moderate to severe, the patient is intolerant to oral iron, erythropoietin agents are being used, or a rapid response (ie, planned surgery) is needed [Aksan 2017], [Gomollón 2013].
Iron deficiency in heart failure with reduced ejection fraction
Data from two randomized, double-blind, placebo-controlled trials (Fair-HF and CONFIRM-HF) in patients with New York Heart Association (NYHA) functional class II or III heart failure with reduced ejection fraction and iron deficiency (with or without anemia) support the use of ferric carboxymaltose for improvement in symptoms, functional capacity, and quality of life [Anker 2009], [Ponikowski 2015].
The European Society for Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure and the ACC/AHA/HFSA guidelines for the management of heart failure suggest that ferric carboxymaltose may be considered in symptomatic patients with heart failure associated with reduced ejection fraction (HFrEF) and iron deficiency to improve symptoms as well as exercise capacity and quality of life [ACC/AHA/HFSA [Yancy 2017]], [ESC [Ponikowski 2016]].
Restless legs syndrome
Data from double-blind randomized, placebo-controlled studies support the use of ferric carboxymaltose in the treatment of restless legs syndrome (RLS), regardless of serum ferritin concentrations [Allen 2011], [Cho 2016], [Trenkwalder 2017].
Based on the guidelines from the International Restless Legs Syndrome Study Group, the European Restless Legs Syndrome Study Group and the Restless Legs Syndrome Foundation, iron supplementation is recommended for RLS patients with low iron stores [Garcia-Borreguero 2016]. Based on the American Academy of Neurology guidelines for the treatment of restless legs syndrome in adults, ferric carboxymaltose likely improves RLS symptoms in patients with moderate to severe RLS regardless of ferritin level [AAN [Winkelman 2016]].
Hypersensitivity to ferric carboxymaltose or any component of the formulation
Note: Dose expressed as elemental iron.
Abdominal surgery, major (perioperative anemia management) (off-label use): IV: 15 mg/kg prior to surgery; maximum dose: 1,000 mg. Postoperatively (within 2 days of surgery), patients received 0.5 mg ferric carboxymaltose per 1 mL of blood loss (if blood loss was at least 100 mL) (Froessler 2016).
Chemotherapy-associated anemia (off-label use): IV: Median total ferric carboxymaltose dose: 1,000 mg (range: 600 to 1,500 mg) (Steinmetz 2013); consider dividing larger doses to a maximum single dose of 750 mg and separate by 7 days.
Iron deficiency anemia: IV:
<50 kg: 15 mg/kg on day 1; repeat dose after at least 7 days (maximum: 750 mg/single dose; 1,500 mg 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: 750 mg/single dose; 1,500 mg per course). May repeat course of therapy if anemia reoccurs.
Iron deficiency anemia in inflammatory bowel disease (off-label use): IV: 500 or 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 (Evstatiev 2011)
Iron deficiency in heart failure with reduced ejection fraction (off-label use): Note: Patients may or may not be anemic. Iron deficiency in clinical trials was defined as a serum ferritin level <100 mcg/L or a serum ferritin level of 100 to 300 mcg/L if transferrin saturation is <20% (Anker 2009; Ponikowski 2015).
IV: 200 mg once weekly (until iron repletion is achieved), and then 200 mg once every 4 weeks during maintenance (starting at week 8 or 12, depending on the required iron-repletion dose) (Anker 2009) or 500 or 1,000 mg/dose at baseline and week 6, followed by 500 mg/dose at weeks 12, 24, and 36 if iron deficiency is still present (dose based on screening weight and hemoglobin values; refer to protocol for specific details; Ponikowski 2015).
Restless legs syndrome (off-label use): IV: 1,000 mg administered over 15 minutes (Cho 2016; Trenkwalder 2017).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
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 to a concentration of 2 to 4 mg/mL; concentration should be ≥2 mg/mL. Discard unused portion of vial (single-use).
IV: Administer as slow IV push (undiluted) at a rate of ~100 mg/minute or 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 2-4 mg/mL are stable for 72 hours at room temperature.
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Avoid combination
Serum or transferrin bound iron levels may be falsely elevated if assessed within 24 hours of ferric carboxymaltose administration.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Endocrine & metabolic: Hypophosphatemia (<2 mg/dL: 27%; transient)
1% to 10%:
Cardiovascular: Increased systolic blood pressure (6%; transient), flushing (4%), hypertension (4%), hypotension (1%)
Dermatologic: Skin discoloration at injection site (1%)
Gastrointestinal: Nausea (7%), vomiting (2%), dysgeusia (1%)
Hepatic: Increased serum alanine aminotransferase (1%)
Nervous system: Dizziness (2%), headache (1%)
<1%: Abdominal pain, anaphylaxis, diarrhea, increased gamma-glutamyl transferase, irritation at injection site, nonimmune anaphylaxis, pain at injection site, paresthesia, skin rash, sneezing
Postmarketing: Angioedema, arthralgia, back pain, chest discomfort, chills, constipation, dyspnea, erythema of skin, fever, hypersensitivity reaction, osteomalacia (hypophosphatemic), pruritus, syncope, tachycardia, urticaria
Concerns related to adverse effects:
• Hypersensitivity: Serious hypersensitivity reactions, including anaphylactic-type reactions (some life-threatening and fatal) have been reported. Monitor during and for at least 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.
• Hypophosphatemia: Symptomatic hypophosphatemia has been reported. Most cases occurred after repeated exposure in patients without a history of renal impairment and resolved within 3 months. Risk factors may include a history of GI disorders associated with malabsorption of fat-soluble vitamins or phosphate, use (current or prior) of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, and malnutrition. Monitor serum phosphate levels in patients at risk for hypophosphatemia who require a repeat course of treatment.
• Laboratory alterations: Lab assays may overestimate serum iron and transferrin bound irons for ~24 hours after infusion.
Hemoglobin and hematocrit, serum ferritin, iron 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).
Ferric carboxymaltose was not found to cross the placenta in an in vitro placental perfusion study (Malek 2010).
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. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001). Untreated iron deficiency and iron deficiency anemia (IDA) in a pregnant patient may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; BSH [Pavord 2020]; IOM 2001).
In general, treatment of iron deficiency or IDA in pregnancy is the same as in nonpregnant patients (USPSTF [Siu 2015]). The majority of studies note iron therapy improves maternal hematologic parameters, however, information related to clinical outcomes in the mother and neonate is limited (FIGO 2019; Qassim 2018; USPSTF [Siu 2015]). Oral preparations are generally sufficient; however, parenteral iron therapy may be used in pregnant patients who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008; BSH [Pavord 2020]).
Ferric carboxymaltose has been evaluated for the treatment of IDA during pregnancy (Aporta Rodriguez 2016; Breymann 2017; Froessler 2018; Khalafallah 2018; Qassim 2018; Shim 2018). 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 (BSH [Pavord 2020]; FIGO 2019).
What is this drug used for?
• It is used to treat anemia.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Low phosphate like vision changes, confusion, mood changes, muscle pain, muscle weakness, shortness of breath, trouble breathing, or trouble swallowing
• Passing out
• Vision changes
• Injection site leaking of fluid
• Severe headache
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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