ferric carboxymaltose

ferric carboxymaltose

(fer-ik car-box-ee-mal-tose) ,

Injectafer

(trade name)

Classification

Therapeutic: antianemics
Pharmacologic: iron supplements
Pregnancy Category: C

Indications

Treatment of iron deficiency anemia in adults who cannot tolerate/have an unsatisfactory response to oral iron or who have chronic kidney disease (non-dialysis dependent)

Action

A colloidal iron complex that releases iron into circulation.

Therapeutic effects

Iron replacement with improvement in indeces and symptoms of iron deficiency.

Pharmacokinetics

Absorption: Iron released from colloid is rapidly bioavailable.
Distribution: Unk
Metabolism and Excretion: Iron is rapidly cleared from plasma and used in hemoglobin formation. Negligable renal elimination
Half-life: 7–12 hr

Time/action profile (improved indeces)

ROUTEONSET PEAK DURATION
IV1–2 mosunkunk

Contraindications/Precautions

Contraindicated in: Hypersensitivity
Use Cautiously in: Geriatric: Elderly may be more sensitive to effects Obstetric: Use during pregnancy only if potential benefit justifies risk to fetus Lactation: Use cautiously Pediatric: Safe and effective use in children has not been established

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Cardiovascular

  • hypertension
  • hypotension

Gastrointestinal

  • constipation
  • dysgeusia
  • ↑ liver enzymes
  • nausea
  • vomiting

Dermatologic

  • flushing

Fluid and Electrolyte

  • hypophosphatemia

Local

  • extravasation with skin discoloration

Miscellaneous

  • hypersensitivity reactions including anaphylaxis

Interactions

Drug-Drug interaction

None noted

Route/Dosage

Intravenous (Adults ≥ 50 kg) 750 mg, followed at least 7 days later by a second dose of 750 mg (total cumulative dose 1500 mg/course)
Intravenous (Adults < 50 kg) 15 mg/kg, followed at least 7 days later by a second dose of 15 mg/kg (

Availability

Iron complex for intravenous injection: 750 mg/15 ml single-use vial

Nursing implications

Nursing 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 blood pressure 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.
    • May cause ↑ ALT.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Dose is expressed in elemental iron. Each mL of ferric carboxymaltose contain 50 mg of elemental iron.
  • Intravenous Administration
  • Administer undiluted.
  • Rate: Inject over 100 mg (2 mL)/min.
  • Intermittent Infusion: Diluent: Dilute 750 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 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.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Treatment of iron deficiency anemia with improvements in hemoglobin, serum ferritin, and transferrin saturation.
References in periodicals archive ?
The latter implicated that, due to the reduction in personnel costs and expenses related to the use and removal of disposable materials, ferric carboxymaltose may generate a saving for the hospital of between 263.40 and 87.10 [euro] compared to 1 or 2 vials of ferric gluconate per session, respectively.
Ferric carboxymaltose was administered in a dose of 500 mg and the patient tolerated this treatment with no skin lesions, ferritin elevation to 49 [micro]g/L, and increased response to epoetin.
Intravenous iron formulations such as ferric carboxymaltose, iron dextran, ferric gluconate, and iron sucrose may potentially solve these issues and may be more convenient both to healthcare providers and patients, if oral iron therapy does not provide the required correction of iron deficiency or is not well-tolerated by patients [4, 6, 9].
NEW ORLEANS -- Oral iron supplementation was declared ineffective for the treatment of iron deficiency in patients with heart failure with reduced ejection fraction in one major randomized trial while intravenous ferric carboxymaltose improved exercise capacity and quality of life in another study presented at the American Heart Association scientific sessions.
The acquisition of Relypsa is expected to significantly strengthen Vifor Pharma ahead of the planned division of the Galenica Group into two independent companies in 2017, with an extensive specialist product portfolio to include both the intravenous iron deficiency treatment Ferinject (ferric carboxymaltose) and Veltassa.
Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study.
The most common intravenous iron products include iron dextran (Cosmofer[R]), ferric carboxymaltose (Ferinject[R]), and iron sucrose (Venofer[R]) (Murphy et al., 2010).
iron treatment (ferric carboxymaltose, FCM, Vifor Pharma) modulates doxorubicin- (DOX-) induced AIC.
Injectafer[R] (ferric carboxymaltose injection) is an important advance and a new treatment option for the correction of this condition.
Among IV iron formulations, iron isomaltoside, ferric carboxymaltose, and the iron dextrans (IDs) can be administered in total dose infusion (TDI).
Ferric carboxymaltose is another encapsulated IV iron that can be administered as a large-dose rapid injection.
The researchers randomized patients on a two-to-one basis to receive an intravenous, bolus injection of ferric carboxymaltose equivalent to 200 mg iron weekly or placebo.