Usual Adult Dose for Iron Deficiency Anemia

Patients weighing 50 kg or more: 1000 mg elemental iron intravenously over at least 20 minutes as a single dose

• Repeat if iron deficiency anemia reoccurs.

Patients weighing under 50 kg: 20 mg/kg (actual body weight) elemental iron intravenously over at least 20 minutes as a single dose

• Repeat if iron deficiency anemia reoccurs.

Comments:

• Only administer when personnel and therapies for serious hypersensitivity reactions are immediately available.
• Dosing is expressed in elemental iron; each mL of Monoferric(R) contains 100 mg elemental iron.

Uses: Iron deficiency in patients intolerant to, or with an unsatisfactory response to, oral iron, and non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Renal Dose Adjustments

See Usual Adult Dose

Liver Dose Adjustments

Data not available

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• Serious hypersensitivity to any of the ingredients; shock, clinically significant hypotension, loss of consciousness and/or collapse have occurred.

Safety and efficacy have not been established in patients younger than 18 years.
This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Inspect for particulates or discoloration prior to administration.
• Administer intravenously over at least 20 minutes.
• Extravasation may cause brown discoloration (possibly long lasting) at the extravasation site; discontinue administration at extravasation site.
• Only administer when personnel and therapies for serious hypersensitivity reactions are immediately available.

Storage requirements: Store at controlled room temperature; do not freeze.

Reconstitution/preparation techniques:

• Withdraw appropriate volume of drug and dilute in 100 to 500 mL 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• May store at room temperature for up to 8 hours after dilution.

IV compatibility:

• Compatibility with other drugs has not been established.
• Do not mix with or add to solutions containing other drugs.