Ferric derisomaltose
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Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Monoferric is single-dose only. Discard unused portion. Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
Final diluted concentration should be more than 1 mg iron/mL. Compatibility of Monoferric with other drugs has not been established. Monoferric should not be mixed with or physically added to solutions containing other drugs. Administer the prepared solution via intravenous infusion over at least 20 minutes. Following dilution with 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored at room temperature for up to 8 hours.
Extravasation of Monoferric may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Monoferric administration at that site.
Contraindications
Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1) , Description (11) ) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Serious hypersensitivity to Monoferric or any of its components. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ferric derisomaltose. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on Monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see Data ) .
There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ) . Iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. The findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency.
Animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (MRHD) of 1000 mg, respectively, based on body surface area ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA includes increased risk for preterm delivery and low birth weight.
Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Monoferric) which may cause fetal bradycardia, especially during the second and third trimester. Data Animal Data Iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. The highest recommended…
Breastfeeding (LactMed)
Limited data indicate that breastmilk iron is increased 3 days after an intravenous infusion of ferric derisomaltose (formerly called iron isomaltoside), but levels remain within the normal range. By 7 days after the dose, breastmilk iron levels were similar to that of mothers taking oral iron. Ferric derisomaltose appears to be acceptable to use in nursing mothers with no special precautions required. For additional information on iron use during breastfeeding, see the monograph on Iron Salts.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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