ferric derisomaltose

Therapeutic Classification: antianemics

Pharmacologic Classification: iron supplements

Indications ⬆ ⬇

REMS

Iron deficiency anemia in patients who cannot tolerate/have an unsatisfactory response to oral iron or who have chronic kidney disease (non-dialysis dependent).

Action ⬆ ⬇

A colloidal iron complex that releases iron into circulation.

Therapeutic effects:

Improvement in hemoglobin concentrations.

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Iron is rapidly cleared from plasma and used in hemoglobin formation. Small quantities of iron excreted in urine and feces.

Half-Life: 27 hr.

Time/Action Profile ⬆ ⬇

(serum ferritin concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	7 days	4 wk

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

OB: Severe hypersensitivity reactions may occur which can lead to bradycardia in fetus, especially during second and third trimesters;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may be more sensitive to effects.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

F and E: hypophosphatemia

GI: nausea

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, SHOCK, AND LOSS OF CONSCIOUSNESS)

Interactions ⬆ ⬇

Drug-drug:

None reported

Route/Dosage ⬆ ⬇

IV (Adults ≥50 kg): 1000 mg as single dose; may repeat dose if iron deficiency anemia recurs.
IV (Adults <50 kg): 20 mg/kg (actual body weight) as single dose; may repeat dose if iron deficiency anemia recurs.

Availability ⬆ ⬇

Solution for injection: 100 mg/mL

Assessment ⬆ ⬇

Assess nutritional status and dietary history to determine need for patient teaching.
Monitor for signs and symptoms of hypersensitivity reactions (rash, itching, wheezing, dizziness, swelling, and breathing problems) during and after infusion for at least 30 min and until clinically stable following completion of infusion. Only administer ferric derisomaltose when personnel and equipment are immediately available for treatment of serious hypersensitivity reactions.
Assess for extravasation frequently during infusion. Extravasation may cause long lasting brown discoloration at extravasation site. If extravasation occurs, discontinue infusion at that site.

Lab Test Considerations:

Monitor hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during iron therapy.

Implementation ⬆ ⬇

Dose is expressed in mg of elemental iron. Each mL contains 100 mg of elemental iron.
Intermittent Infusion: Diluent: Dilute dose in 100–500 mL 0.9% NaCl.Concentration: >1 mg iron/mL. Solution is dark brown and non-transparent; do not infuse solutions that are discolored or contain particulate matter. Solution is stable for up to 8 hr at room temperature.
Rate: Infuse over 20 min.
Y-Site Incompatibility: Do not mix with or add to other drugs.

Patient/Family Teaching ⬆ ⬇

Explain purpose of medication to patient.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions occur.
Caution patient to notify health care professional promptly if extravasation at IV site occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Severe maternal reactions (circulatory failure, severe hypotension, shock, anaphylaxis) may occur increasing risk for preterm delivery and low birth weight. May cause fetal bradycardia, especially in 2nd and 3rd trimester. Monitor breastfed infants for GI toxicity (constipation, diarrhea).

Evaluation/Desired Outcomes ⬆ ⬇

Improved hemoglobin concentrations.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

62287- Wasserburger Arzneimittelwerk GmbH
- 62287-931-
  - 62287-931-10- 186 VIAL in 1 TRAY (62287-931-10) / 10 mL in 1 VIAL

73594- Pharmacosmos Therapeutics Inc.
- 73594-9301- Monoferric
  - 73594-9301-2- 5 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3)

73594- Pharmacosmos Therapeutics Inc.
- 73594-9305- Monoferric
  - 73594-9305-1- 1 VIAL in 1 BOX (73594-9305-1) / 5 mL in 1 VIAL

73594- Pharmacosmos Therapeutics Inc.
- 73594-9310- Monoferric
  - 73594-9310-1- 1 VIAL in 1 BOX (73594-9310-1) / 10 mL in 1 VIAL

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Pronunciation ⬇

Classifications ⬆ ⬇