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)

ROUTE	ONSET	PEAK	DURATION
IV	1–2 mos	unk	unk

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 ?

Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.

Current Considerations for Recognizing and Treating Iron Deficiency Anemia in Women

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).

AMAG Pharmaceuticals enrolls first patient under head-to-head, Phase 3 clinical trial to evaluate the safety of Feraheme in adults with iron deficiency anemia

The Food and Drug Administration has issued a "not approvable" letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.

FDA finds injectable anemia drug 'not approvable'

But Daiichi Sankyo Co., 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.

Astellas Pharma Inc

-- Concerns about off-label use and a mortality safety signal associated with treatment in clinical trials swayed a federal advisory panel against supporting the approval of ferric carboxymaltose injection (Injectafer), a new intravenous iron product, as a first-line treatment for iron deficiency anemia in postpartum women and in women with heavy uterine bleeding.

Concerns about off-label use may derail approval of IV iron

-- A federal advisory panel voted against supporting the approval of ferric carboxymaltose injection (Injectafer), a new intravenous iron product, as a first-line treatment for iron deficiency anemia in postpartum women and in women with heavy uterine bleeding.

Panel favors restricted use of IV iron product

We believe that this broad approval, together with the recent clinical trial data on Feraccru that showed it to be non-inferior in treatment effect to Ferinject/ Injectafer, the leading IV iron therapy, can lead to a change in the current paradigm for the treatment iron deficiency anaemia.'

Shield Therapeutics PLC - FDA approves Feraccru with a broad label of treating iron deficiency in adults

An alternative regimen is to administer 750 mg of ferrous carboxymaltose (Injectafer, Luitpold Pharmaceuticals) over 15 minutes, which is an FDA-approved regimen.

Recognize and treat iron deficiency anemia in pregnant women: By measuring ferritin levels and treating with oral and IV iron, obstetricians can close the gap in the care of pregnant women with iron deficiency anemia

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 7.5 million people in the U.S.

21 Daiichi Sankyo

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.

Daiichi Sankyo's Luitpold seeks FDA nod for IV iron replacement therapy Injectafer

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.

ferric carboxymaltose