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Monoferric Generic Name & Formulations
Legal Class
Rx
General Description
Elemental iron (as ferric derisomaltose) 100mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Hematinic.
How Supplied
Single-dose vials (1mL)—5; (5mL, 10mL)—1
Manufacturer
Generic Availability
NO
Monoferric Indications
Indications
Iron deficiency anemia (IDA) in adults who have intolerance to oral iron or unsatisfactory response to oral iron; or have non-hemodialysis dependent chronic kidney disease (CKD).
Monoferric Dosage and Administration
Adult
Give by IV infusion over ≥20mins. <50kg: 20mg/kg (of actual body wt.) once as a single dose. ≥50kg: 1000mg once as a single dose. Both: repeat if IDA reoccurs.
Children
Not established.
Monoferric Contraindications
Not Applicable
Monoferric Boxed Warnings
Not Applicable
Monoferric Warnings/Precautions
Warnings/Precautions
Administer only when personnel and medical support are immediately available. Monitor for hypersensitivity reactions during and after administration for ≥30mins and until clinically stable. Monitor hemoglobin, hematocrit, serum ferritin, and transferrin saturation. Avoid in those with iron overload. Monitor for extravasation; discontinue if occurs. Elderly. Neonates. Pregnancy. Nursing mothers: monitor infants for GI toxicity.
Monoferric Pharmacokinetics
See Literature
Monoferric Interactions
Not Applicable
Monoferric Adverse Reactions
Adverse Reactions
Rash, nausea; hypersensitivity reactions, hypophosphatemia, possible iatrogenic hemosiderosis or hemochromatosis.
Monoferric Clinical Trials
See Literature
Monoferric Note
Not Applicable
Monoferric Patient Counseling
See Literature
