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Ferric Carboxymaltose

Medically reviewed on March 25, 2018

Pronunciation

(FER ik kar box ee MAWL tose)

Index Terms

  • Ferinject
  • Iron Carboxymaltose
  • Iron Dextri-Maltose
  • VIT 45

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Injectafer: 750 mg/15 mL (15 mL)

Brand Names: U.S.

  • Injectafer

Pharmacologic Category

  • Iron Salt

Pharmacology

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

Excretion

Urine (negligible)

Time to Peak

0.25 to 1.2 hours following administration

Half-Life Elimination

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

Restless legs syndrome

The American Academy of Neurology guidelines for the treatment of restless legs syndrome (RLS) recommend the use of ferric carboxymaltose, regardless of ferritin level, for the improvement of RLS symptoms in patients with moderate to severe RLS.

Contraindications

Hypersensitivity to ferric carboxymaltose or any component of the formulation

Dosing: Adult

Note: Dose expressed as elemental iron

Iron-deficiency anemia: IV:

<50 kg: 15 mg/kg elemental iron on day 1; repeat dose after at least 7 days (maximum: 1,500 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: 1,500 mg per course). May repeat course if anemia reoccurs.

Restless legs syndrome (off-label use): IV: 500 mg on day 1; repeat after 5 days (AAN [Winkelman 2016])

Dosing: Geriatric

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

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

Reconstitution

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).

Administration

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.

Storage

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.

Drug Interactions

Bictegravir: Iron Salts may decrease the serum concentration of Bictegravir. Management: Bictegravir, emtricitabine, and tenofovir alafenamide can be administered with iron salts under fed conditions, but coadministration with or 2 hours after an iron salt is not recommended under fasting conditions. Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Avoid combination

Test Interactions

Serum or transferrin bound iron levels may be falsely elevated if assessed within 24 hours of ferric carboxymaltose administration.

Adverse Reactions

>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%, postmarketing, and/or case reports: Abdominal pain, anaphylaxis, angioedema, arthralgia, back pain, chest discomfort, chills, diarrhea, dyspnea, erythema, fever, hypersensitivity, increased gamma-glutamyl transferase, irritation at injection site, pain at injection site, paresthesia, pruritus, skin rash, sneezing, syncope, tachycardia, urticaria

Warnings/Precautions

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Laboratory alterations: Lab assays may overestimate serum iron and transferrin bound irons for ~24 hours after infusion.

Monitoring Parameters

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 Considerations

Ferric carboxymaltose has been evaluated for the treatment of iron deficiency anemia (IDA) during pregnancy (Aporta Rodriguez 2016; Breymann 2017; Froessler 2014; Pels 2015) and postpartum (Breymann 2008).

Untreated IDA is associated with adverse pregnancy outcomes including low birth weight, preterm delivery, and maternal postpartum anemia.

Iron requirements increase during pregnancy. All females should be screened for iron deficiency during pregnancy; if IDA is present, supplemental iron (in addition to prenatal vitamins) should be administered. Oral preparations are generally sufficient, however parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008).

Patient Education

• 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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