Ferric Carboxymaltose (ferric carboxymaltose)

Dosage of ferric carboxymaltose is expressed in terms of elemental iron. Each mL of ferric carboxymaltose injection contains the equivalent of 50 mg of elemental iron.

Ferric carboxymaltose is administered by slow IV injection or IV infusion only. When given by slow IV injection, the drug is administered undiluted at a rate of approximately 100 mg (2 mL)/minute. When given by IV infusion, up to 750 mg of iron should be diluted in no more than 250 mL of 0.9% sodium chloride injection, providing a concentration of no less than 2 mg/mL of iron; the diluted solution should be administered over at least 15 minutes.

When added to an infusion bag containing 0.9% sodium chloride injection, ferric carboxymaltose solutions containing 2-4 mg/mL of iron are physically and chemically stable for 72 hours when stored at room temperature. Any unused portion of the diluted or undiluted ferric carboxymaltose solution should be discarded. Ferric carboxymaltose injection and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to administration.

Extravasation of ferric carboxymaltose should be avoided. Extravasation of the drug may cause brown discoloration of the extravasation site, which may be long lasting. The injection site should be monitored for extravasation during administration of ferric carboxymaltose. If extravasation occurs, ferric carboxymaltose administration at the affected site should be discontinued.

Patients should be monitored for hypersensitivity reactions during and for at least 30 minutes after administration of ferric carboxymaltose until clinically stable. Ferric carboxymaltose should be administered only when appropriate agents and personnel for the treatment of serious hypersensitivity reactions are readily available.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal studies examining drug interactions with ferric carboxymaltose have not been performed to date.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Iron/Dimercaprol

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Dimercaprol can complex with iron, forming a chelation compound that is more toxic than iron alone.(1)

CLINICAL EFFECTS: Concurrent use of dimercaprol and iron may result in toxicity, especially renal toxicity.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Medicinal iron should not be administered to patients receiving dimercaprol.(1)

DISCUSSION: Because the dimercaprol-iron complex is more toxic than iron alone, especially to the kidneys, medicinal iron should not be administered to patients receiving dimercaprol.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to ferric carboxymaltose or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

• Hypophosphatemia

• Hypertension

Adverse effects reported in at least 1% of patients receiving ferric carboxymaltose in 2 randomized clinical trials include nausea, hypertension, flushing/hot flush, hypophosphatemia, dizziness, vomiting, injection site discoloration, headache, increased serum ALT concentration, dysgeusia, and hypotension.

More Frequent

• Hypertension
• Hypophosphatemia

Less Frequent

• Abnormal hepatic function tests
• Hypotension
• Increased alanine transaminase

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Dyspnea
• Hypersensitivity drug reaction

More Frequent

• Dizziness
• Flushing
• Nausea
• Urticaria

Less Frequent

• Acute abdominal pain
• Arthralgia
• Chest pain
• Diarrhea
• Dyschromia
• Dysgeusia
• Edema
• Headache disorder
• Injection site sequelae
• Muscle spasm
• Pharyngitis
• Vomiting

Rare or Very Rare

• Back pain
• Chills
• Constipation
• Erythema
• Fever
• Paresthesia
• Pruritus of skin
• Skin rash
• Sneezing
• Syncope
• Tachycardia

No enhanced messaging available.

Safety and efficacy of ferric carboxymaltose have not been established in pediatric patients.

Category C. (See Users Guide.)

In lactating women with postpartum iron deficiency anemia, mean breast milk iron concentrations were higher in women receiving IV ferric carboxymaltose than in those receiving oral ferrous sulfate. Ferric carboxymaltose should be used with caution in nursing women.

In overall clinical trials of ferric carboxymaltose, 50% of patients were 65 years of age or older, while 25% were 75 years of age and older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience has revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.