ferric carboxymaltose (Rx)

Brand and Other Names:Injectafer
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Safety and efficacy not established

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Adverse 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

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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
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Pregnancy & Lactation

Pregnancy

Studies on use in pregnant women have not reported adverse developmental outcomes; however, these studies cannot establish or exclude absence of any drug-related risk during pregnancy because studies were not designed to assess for risk of major birth defects; there are risks to mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy

Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight

Lactation

Available published data on use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk; however, the data do not inform the full potential exposure of iron for breastfed infant; among breastfed infants, there were no adverse events reported that were considered related to ferric carboxymaltose exposure through breastmilk; there is no information on effects of ferric carboxymaltose on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy in addition to any potential adverse effects on breastfed child from drug or from underlying maternal condition

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.

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Pharmacology

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

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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

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.