iron sucrose injection
Venofer

Pharmacologic classification: polynuclear iron(III)-hydroxide in sucrose
Therapeutic classification: hematinic
Pregnancy risk category B


Available forms
Available by prescription only
Injection: 20 mg/ml of elemental iron

Indications and dosages
 Iron deficiency anemia in patients undergoing long-term hemodialysis who are receiving supplemental erythropoietin therapy. Adults: 100 mg (5 ml) of elemental iron I.V. directly in the dialysis line either by slow injection (1 ml per minute) or by infusion over 15 minutes during the dialysis session one to three times weekly to a total of 1,000 mg in 10 doses. Repeat if needed.

Pharmacodynamics
Iron replacement action: Iron is essential to the synthesis of hemoglobin to maintain oxygen transport and to the function and formation of other physiologically important heme and non-heme compounds. Following administration, drug is dissociated by the reticuloendothelial system into iron and sucrose. The released iron component eventually replenishes depleted body iron stores, resulting in significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity.

Pharmacokinetics
Absorption: Administered I.V.
Distribution: Distributed mainly in blood and somewhat in extravascular fluid. A significant amount of iron is also distributed in the liver, spleen, and bone marrow.
Metabolism: Drug is dissociated by the reticuloendothelial system into iron and sucrose.
Excretion: About 75% of sucrose and 5% of the iron component are eliminated by urinary excretion in 24 hours. In healthy adults, elimination half-life is 6 hours.

Route Onset Peak Duration
I.V. Unknown Unknown Variable


Interactions
Drug-drug. Oral iron preparations: Reduces absorption of these compounds. Avoid use together.

Adverse reactions
CNS: headache, asthenia, malaise, dizziness, fever, pain.
CV: hypotension, chest pain, hypertension, fluid retention.
GI: nausea, vomiting, diarrhea, abdominal pain.
Musculoskeletal: leg cramps, bone and muscle pain.
Respiratory: dyspnea, pneumonia, cough.
Skin: pruritus, application site reaction.
Other: accidental injury.

Effects on lab test results
• May increase liver enzyme levels.

Overdose and treatment
Signs and symptoms of overdose or too-rapid infusion include hypotension, headache, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and CV collapse.
 Administering the solution more slowly and treating with I.V. fluids, hydrocortisone, or antihistamines may alleviate most symptoms.

Contraindications and precautions
Contraindicated in patients with evidence of iron overload, patients hypersensitive to drug or any of its inactive components, and patients with anemia not caused by iron deficiency.

Special considerations
• Rare but fatal hypersensitivity reactions characterized by anaphylaxis, loss of consciousness, collapse, hypotension, dyspnea, or seizures have been reported.
• For administration by slow injection, administer at 1 ml (20 mg elemental iron) undiluted solution per minute, not exceeding one vial (100 mg elemental iron) per injection.
• For administration by infusion, dilute to a maximum of 100 ml in normal saline solution immediately before infusion, and infuse 100 mg elemental iron over at least 15 minutes.
• Administering by infusion may reduce the risk of hypotension.
• Transferrin saturation values increase rapidly after I.V. administration of iron sucrose. Obtain serum iron values 48 hours after I.V. dosing.
• Monitor hemoglobin, hematocrit, serum ferritin, and transferrin saturation.
• Withhold dose in patients with evidence of iron overload.
• Don’t mix with other medications or add to parenteral nutrition solutions of I.V. infusion.
• Inspect for particulate matter and discoloration before administration.
Breast-feeding patients
• It’s not known whether drug appears in breast milk. Use cautiously in breast-feeding women.
Pediatric patients
• Safety and efficacy haven’t been established.
Geriatric patients
• Dose selection in elderly patients should be conservative because of the possibility that they have decreased hepatic, renal, and cardiac function; concomitant disease; and other drug therapy.

Patient education
• Instruct patient to call if symptoms of overdose occur, such as headache, nausea, dizziness, joint aches, paresthesia, or abdominal and muscle pain.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use