ferric carboxymaltose

General

Pronunciation:
fer-ik car-box-ee-mal-tose


Trade Name(s)

  • Injectafer

Ther. Class.

antianemics

Pharm. Class.

iron supplements

Indications

  • Iron deficiency anemia in patients who have non-dialysis-dependent chronic kidney disease.
  • Iron deficiency anemia in patients who cannot tolerate or have an unsatisfactory response to oral iron.
  • Iron deficiency in patients with New York Heart Association class II or III HF.

Action

A colloidal iron complex that releases iron into circulation.

Therapeutic Effect(s):

  • Improvement in indices and symptoms of iron deficiency.
  • Improvement in exercise capacity in patients with HF.

Pharmacokinetics

Absorption: Iron released from colloid is rapidly bioavailable.

Distribution: Unknown.

Metabolism and Excretion: Iron is rapidly cleared from plasma and used in hemoglobin formation. Negligible renal elimination.

Half-life: 7–12 hr.

TIME/ACTION PROFILE (improved indices)

ROUTEONSET PEAK DURATION
IV1–2 mounknownunknown

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity.

Use Cautiously in:

  • GI disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent/prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, or malnutrition (↑ risk of hypophosphatemia);
  • OB:   Severe hypersensitivity reactions may occur that can lead to bradycardia in fetus, especially during 2nd and 3rd trimesters;
  • Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
  • Pedi:  Children <1 yr (safety and effectiveness not established);
  • Geri:  Older adults may be more sensitive to effects.

Adverse Reactions/Side Effects

CV: hypertension, hypotension

Derm: flushing

F and E: hypophosphatemia

GI: constipation, ↑ liver enzymes, nausea, vomiting

Local: extravasation with skin discoloration

Neuro: dizziness, dysgeusia, headache

Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None reported.

Route/Dosage

Iron Deficiency Anemia in Patients Who Cannot Tolerate or Have an Unsatisfactory Response to Oral Iron

IV (Adults and Children ≥1 yr and ≥50 kg): 750 mg initially, followed at least 7 days later by a second dose of 750 mg (total cumulative dose = 1500 mg/course)  OR  15 mg/kg (max dose = 1000 mg) as a single dose.

IV (Adults and Children ≥1 yr and <50 kg): 15 mg/kg initially, followed at least 7 days later by a second dose of 15 mg/kg.

Iron Deficiency Anemia in Patients with Non-Dialysis-Dependent Chronic Kidney Disease

IV (Adults ≥50 kg): 750 mg initially, followed at least 7 days later by a second dose of 750 mg (total cumulative dose = 1500 mg/course)  OR  15 mg/kg (max dose = 1000 mg) as a single dose.

IV (Adults <50 kg): 15 mg/kg initially, followed at least 7 days later by a second dose of 15 mg/kg.

Iron Deficiency in Heart Failure

IV (Adults ≥70 kg): Hgb >14–<15 g/dL: 500 mg initially, then 500 mg at Wk 12, Wk 24, and Wk 36 if serum ferritin <100 ng/mL or if serum ferritin 100–300 ng/mL with transferrin saturation <20%.  Hgb 10–14 g/dL: 1000 mg initially, then 500 mg at Wk 6, then 500 mg at Wk 12, Wk 24, and Wk 36 if serum ferritin <100 ng/mL or if serum ferritin 100–300 ng/mL with transferrin saturation <20%.  Hgb <10 g/dL: 1000 mg initially, then 1000 mg at Wk 6, then 500 mg at Wk 12, Wk 24, and Wk 36 if serum ferritin <100 ng/mL or if serum ferritin 100–300 ng/mL with transferrin saturation <20%.

IV (Adults <70 kg): Hgb >14–<15 g/dL: 500 mg initially, then 500 mg at Wk 12, Wk 24, and Wk 36 if serum ferritin <100 ng/mL or if serum ferritin 100–300 ng/mL with transferrin saturation <20%.  Hgb 10–14 g/dL: 1000 mg initially, then 500 mg at Wk 12, Wk 24, and Wk 36 if serum ferritin <100 ng/mL or if serum ferritin 100–300 ng/mL with transferrin saturation <20%.  Hgb <10 g/dL: 1000 mg initially, then 500 mg at Wk 6, then 500 mg at Wk 12, Wk 24, and Wk 36 if serum ferritin <100 ng/mL or if serum ferritin 100–300 ng/mL with transferrin saturation <20%.

Availability

Solution for injection: 50 mg/mL

Assessment

  • Monitor for signs and symptoms of hypersensitivity reactions (hypotension, loss of consciousness, pruritus, rash, urticaria, wheezing) for at least 30 min and stable following completion of injection.
  • Monitor for injection site for extravasation. May cause long lasting brown discoloration at site. If extravasation occurs, discontinue and administer at another site.
  • Monitor BP during infusion. May cause transient hypertension. May cause facial flushing, dizziness and nausea. Usually resolved within 30 min following injection.

Lab Test Considerations:

Monitor hemoglobin, serum ferritin, and transferrin saturation prior to and at completion of course of therapy.

  • Correct pre-existing hypophosphatemia prior to starting therapy. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.
  • May cause ↑ ALT.

Implementation

  • Dose is expressed in elemental iron. Each mL of ferric carboxymaltose contain 50 mg of elemental iron.

IV Administration

  • IV Push:  Administer undiluted.
  • Rate: Inject slowly over 100 mg (2 mL)/min.
  • Intermittent Infusion:   Dilution:  Dilute up to 1000 mg of iron in not >250 mL of 0.9% NaCl.  Concentration:  Not <2 mg of iron/mL.Solution should be clear; avoid using solutions that contain particulate matter.
  • Rate: Infuse over 15 min.

Patient/Family Teaching

  • Explain purpose of ferric carboxymaltose to patient. Ask patient if they have a history of reactions to parenteral iron products. Advise patient to read  Patient Information  before starting and periodically during therapy in case of changes.
  • Advise patient to notify health care professional if signs and symptoms of hypersensitivity reaction occurs.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Instruct patient to avoid taking iron supplements during therapy.
  • Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Severe maternal reactions (circulatory failure, severe hypotension, shock, anaphylaxis) may occur, increasing risk for preterm delivery and low birth weight. May cause fetal bradycardia, especially in 2nd and 3rd trimester. Monitor breastfed infants for GI toxicity (constipation, diarrhea).

Evaluation/Desired Outcomes

  • Treatment of iron deficiency anemia with improvements in hemoglobin, serum ferritin, and transferrin saturation.
  • Improvement in exercise capacity in patients with HF.