ferric carboxymaltose

(redirected from Injectafer)

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 ?
Biopharmaceutical company AMAG Pharmaceuticals (NasdaqGS:AMAG) reported on Wednesday the admission of the first patient under its head-to-head, Phase 3 clinical trial to evaluate the safety of Feraheme (ferumoxytol) compared to Injectafer (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA).
The company said the Phase 3 non-inferiority, randomised, double-blind, multicentre clinical trial will evaluate the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis) and moderate to severe hypotension with Feraheme compared to Injectafer in adults with IDA.
New revenue contributors include Pralia, an osteoporosis treatment, which is also being investigated in Phase III studies in breast cancer and rheumatoid arthritis, and subsidiary Luitpold Pharmaceuticals gained FDA approval for Injectafer to treat iron deficiency anemia, a condition that afflicts 7.
The decision was not related to any issues with the Injectafer NDA filing, but with Luitpold s manufacturing facility in Shirley, N.
subsidiary said in a statement on March 12 that the studies are needed to address safety issues with Injectafer, particularly a mortality signal that led the Drug Safety and Risk Management Advisory Committee to vote against its approval in February.
Japan's third-largest drugmaker, failed to win approval for the anemia treatment Injectafer and must perform more tests to address concerns that the medicine may increase the risk of death.
Most of the 17-member panel agreed that these data indicated that Injectafer was associated with a "mortality disadvantage," compared with oral iron.
Most panelists agreed that the data indicated that Injectafer was associated with a "mortality disadvantage," compared with oral iron.
injectable iron market through the launch of Injectafer for iron deficiency anemia.
13 October 2011 - Japanese Daiichi Sankyo Company Limited (TYO:4568) said today its Luitpold Pharmaceuticals Inc subsidiary had filed a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anemia.
Several panelists said they thought that Injectafer was a more practical alternative to the other intravenous iron products currently available, and that more data were available for Injectafer.