Drug Guide
Ferric Derisomaltose
Classification
Therapeutic: Iron deficiency anemia treatment
Pharmacological: Intravenous iron preparation
FDA Approved Indications
- Treatment of iron deficiency anemia in adult patients when oral iron is ineffective or not tolerated
Mechanism of Action
Ferric derisomaltose provides an immediate source of iron, which is used for the synthesis of hemoglobin in iron-deficient erythropoiesis. It delivers bioavailable iron directly to the reticuloendothelial system, replenishing iron stores and supporting erythropoiesis.
Dosage and Administration
Adult: Based on dosing calculations considering patient weight and baseline iron levels; typically administered as a single IV infusion. Specific dosing guidelines are provided in the prescribing information.
Pediatric: Safety and efficacy not established for pediatric patients; use in this population is not recommended unless in clinical trials or under special circumstances.
Geriatric: No specific dosage adjustment required, but caution advised due to potential comorbidities and concurrent medications.
Renal Impairment: No dose adjustment necessary, but careful monitoring is recommended.
Hepatic Impairment: No specific data; use with caution and monitor hepatic function.
Pharmacokinetics
Absorption: Not applicable, as administered intravenously.
Distribution: Iron is distributed to various tissues, primarily to the bone marrow for erythropoiesis.
Metabolism: Metabolized within the reticuloendothelial system to release free iron, which is then incorporated into hemoglobin, ferritin, or used in other cellular processes.
Excretion: Iron is excreted mainly via the reticuloendothelial system; minimal renal excretion.
Half Life: Approximately 8-10 hours in the plasma.
Contraindications
- Hypersensitivity to ferric derisomaltose or any component of the formulation.
Precautions
- Use with caution in patients with active infections, as iron can promote bacterial growth. Monitor for allergic reactions and hypersensitivity. Avoid administration in cases of iron overload or hemochromatosis.
Adverse Reactions - Common
- Headache (Common)
- Gastrointestinal discomfort, nausea, or abdominal pain (Common)
- Hypersensitivity reactions, including anaphylaxis (Uncommon)
Adverse Reactions - Serious
- Anaphylactic reactions (Rare)
- Hypersensitivity reactions include skin rash, itching, swelling, dizziness (Rare)
Drug-Drug Interactions
- Concurrent use with other IV iron products or blood products without proper monitoring.
Drug-Food Interactions
- Food does not significantly affect IV administration but verify with prescribing info.
Drug-Herb Interactions
- Limited data; use caution with herbal supplements that affect iron absorption or bleeding risk.
Nursing Implications
Assessment: Monitor for signs of hypersensitivity during and after infusion. Assess baseline iron status, hemoglobin, and hematocrit.
Diagnoses:
- Risk for allergic reaction related to IV administration.
- Impaired tissue perfusion related to hypersensitivity reactions.
Implementation: Administer IV iron per protocol, ensuring appropriate infusion rates and emergency medications are available.
Evaluation: Observe for adverse reactions during and after infusion. Assess improvement in anemia and patient symptoms.
Patient/Family Teaching
- Report any signs of allergic reactions immediately.
- Inform about potential side effects, such as headache, nausea, or flushing.
- Discuss the importance of follow-up blood tests to assess response and iron status.
Special Considerations
Black Box Warnings:
- Severe allergic reactions, including anaphylaxis, can occur. Preparedness for emergency treatment is essential.
Genetic Factors: No specific genetic considerations documented.
Lab Test Interference: May affect serum iron, ferritin, and transferrin saturation levels temporarily; interpret with caution.
Overdose Management
Signs/Symptoms: Potential for iron overload, including abdominal pain, hypotension, tachycardia, or dizziness.
Treatment: Discontinue infusion, provide supportive care, and consider chelation therapy with deferoxamine in severe cases.
Storage and Handling
Storage: Store at room temperature, away from direct sunlight.
Stability: Stable until expiration date when stored properly.