Monoferric (ferric derisomaltose)

No dosing information is available for this tab.

Ferric derisomaltose is administered IV. During administration, do not mix the ferric derisomaltose solution with solutions containing other medications.

Extravasation of ferric derisomaltose may cause brown discoloration at the extravasation site, which may be long-lasting. Monitor for extravasation. If extravasation occurs, discontinue ferric derisomaltose administration at that site.

Store vials at 20-25degreesC (excursions permitted between 15-30degreesC).

Once diluted, the solution may be stored at room temperature for up to 8 hours.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal studies examining compatibility of ferric derisomaltose with other drugs have not been performed to date.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Iron/Dimercaprol

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Dimercaprol can complex with iron, forming a chelation compound that is more toxic than iron alone.(1)

CLINICAL EFFECTS: Concurrent use of dimercaprol and iron may result in toxicity, especially renal toxicity.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Medicinal iron should not be administered to patients receiving dimercaprol.(1)

DISCUSSION: Because the dimercaprol-iron complex is more toxic than iron alone, especially to the kidneys, medicinal iron should not be administered to patients receiving dimercaprol.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Hypersensitivity to ferric derisomaltose or any of its components.

• Chronic iron overload

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse reactions reported in >=1% of patients receiving ferric derisomaltose include rash and nausea.

Less Frequent

• Hypersensitivity drug reaction

Rare or Very Rare

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

More Frequent

• Nausea
• Skin rash

Less Frequent

• Injection site sequelae

Rare or 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 enhanced messaging available.

Safety and effectiveness have not been established in pediatric patients.

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.

The manufacturer makes no specific dosage recommendations for geriatric patients.

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.