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Drug Safety-related Labeling Changes (SrLC)

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Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/04/2022 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials. Trial 1 enrolled adult patients with iron deficiency anemia with intolerance to oral iron or had an unsatisfactory response to oral iron with a clinical need for repletion of iron stores. Eligible subjects were required to have a baseline hemoglobin of less than or equal to 11g/dl, transferrin saturation (TSAT) of less than 20% and serum ferritin level of <100 ng/mL. Trial 2 enrolled adult patients with non-dialysis dependent chronic kidney disease (CKD) with iron deficiency anemia (see Clinical  Studies (14)). Eligible subjects also had to have serum ferritin less than or equal to 100 ng/mL or less than or equal to 300 ng/mL if TSAT less than or equal to 30%.

8 Use in Specific Populations

8.1 Pregnancy

Ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from GD7 to GD20, at doses of 11, 25 and 43 mg Fe/kg/day. The dose of 43 mg Fe/kg/day (approximately 0.8 times the MRHD of 1000 mg, based on BSA) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. Adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain). Fetal malformations and reduced fetal weights were also noted in the 25 mg Fe/kg/day group (approximately 0.5 times the MRHD based on BSA).

09/11/2020 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

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).

Clinical Considerations

Newly added information:

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.