MONOFERRIC (ferric derisomaltose)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Chronic iron overload

There are 0 severe contraindications.

There are 0 moderate contraindications.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypersensitivity drug reaction

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Angioedema Bronchospastic pulmonary disease Extravasation injury Hemosiderosis Hypertension Hypophosphatemia Hypotension Seizure disorder Unconsciousness

There are 34 less severe adverse reactions.

More Frequent	Less Frequent
Nausea Skin rash	Injection site sequelae

Rare/Very Rare
Acute abdominal pain Arthralgia Back pain Blurred vision Chest pain Chills Constipation Cough Diarrhea Dizziness Dyschromia Dysgeusia Dyspepsia Dyspnea Exfoliative dermatitis Fatigue Fever Flu-like symptoms Flushing Headache disorder Hyperhidrosis Malaise Muscle spasm Myalgia Pain Paresthesia Pruritus of skin Symptoms of anxiety Tachycardia Urticaria Vomiting

No data are available to inform the drug-associated risk of ferric derisomaltose use in pregnancy. Published data on IV iron use in human pregnancies have not reported an association with adverse developmental outcomes; however, these studies were not designed to assess for the risk of birth defects. Untreated iron deficiency anemia in pregnancy has been associated with negative outcomes, including postpartum maternal anemia, an increased risk of preterm delivery, and low birth weight.

However, providers and patients should be aware that the use of parenteral iron products in pregnant women can cause serious adverse reactions including severe hypotension and shock, which can result in fetal bradycardia. Iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals; however, these findings could be a result of iron overload from excessive iron administration, and may not be applicable to patients with anemia. Animal studies of ferric derisomaltose administration during organogenesis resulted in structural abnormalities and embryo-fetal lethality when doses of approximately 0.09-0.4

times the maximum recommended human dose of 1000 mg (based on body surface area) were administered.

Available data indicate that iron is present in the breast milk of lactating women. The effects on breast-fed infants or on the production of milk are not known. Consider the benefits of breastfeeding and the potential for adverse effects from ferric derisomaltose exposure to the breast-fed infant, along with the mother's clinical need for ferric derisomaltose. Monitor breast-fed infants for gastrointestinal toxicities such as constipation and diarrhea.

In clinical studies of ferric derisomaltose, 29% and 13% of patients were >=65 and >=75 years of age, respectively. No overall differences in safety or efficacy have been observed between these patients and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out.