Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 20mg (Fe)/mL
Iron Deficiency Anemia
Indicated for treatment of iron deficiency anemia associated with chronic kidney disease
Hemodialysis-dependent CKD: 100 mg elemental iron IV (injection or infusion over 2-5 min) per dialysis session not to exceed total cumulative dose of 1000 mg divided in 3 doses/week
Non-dialysis-dependent CKD: 200 mg IV injection for 5 doses in over 14 days (cumulative 1000 mg in 14-day period)
Peritoneal dialysis-dependent CKD: 300 mg IV infusion (1.5 hr) for 2 doses 14 days apart, THEN 400 mg IV infusion (2.5 hr) 14 days later (cumulative 1000 mg divided in 3 doses/week)
Dosage Forms & Strengths
injectable solution
- 20mg (Fe)/mL
Iron Deficiency Anemia
Indicated for maintenance treatment of iron-deficient anemia associated with chronic kidney disease
<2 years: Safety and efficacy not established
≥2 years
- Hemodialysis-dependent: 0.5 mg/kg IV q2weeks for 12 weeks; not to exceed 100 mg/dose
- Non-dialysis dependent or peritoneal-dependent (on erythropoietin): 0.5 mg/kg IV q4weeks for 12 weeks; not to exceed 100 mg/dose
Dosing Considerations
Iron replacement treatment in pediatric patients has not been established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Hypotension (36%)
Muscle cramps (23%)
Headache
Nausea
1-10%
Dizziness
Fatigue
Arthralgia
Back pain
Hypertension
Fluid overload
Peripheral edema
Cough
Vomiting
Diarrhea
Constipation
Pruritus
Frequency Not Defined
Potentially fatal anaphylaxis (rare)
Iron overload
Immune system disorders: Anaphylactic-type reactions, angioedema
Psychiatric disorders: Confusion
Nervous system disorders: Convulsions, collapse, light-headedness, loss-of-consciousness
Cardiac disorders: Bradycardia
Vascular disorders: Shock
Respiratory, thoracic and mediastinal disorders: Bronchospasm, dyspnea
Musculoskeletal and connective tissue disorders: Back pain, swelling of the joints
Renal and urinary disorders: Chromaturia
General disorders and administration site conditions: Hyperhidrosis
Warnings
Contraindications
Hypersensitivity
Anemia not caused by iron deficiency
Iron overload
Cautions
Risk of hypotension
Withhold therapy in tissue iron overload
Hypersensitivity
- Serious hypersensitivity reactions reported, including anaphylactic-type reactions, some of which have been life-threatening and fatal
- Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse
- If hypersensitivity reactions or signs of intolerance occur during administration, stop infusion immediately
- Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion
Pregnancy & Lactation
Pregnancy
Published studies on intravenous iron sucrose treatment after first trimester of pregnancy not shown adverse maternal or fetal outcomes; available reports of intravenous iron sucrose use in pregnant women during first trimester are insufficient to assess risk of major birth defects and miscarriage; iron deficiency anemia during pregnancy should be treated because there are risks to mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy; risks to fetus associated with maternal severe hypersensitivity reactions
Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products which may cause fetal bradycardia, especially during second and third trimester
Animal data
- Animal reproduction studies of iron sucrose administered to rats and rabbits during period of organogenesis at elemental iron doses equivalent to maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus; adverse outcomes in pregnancy occur regardless of health of mother or use of medications
- Iron deficiency anemia during pregnancy should be treated; untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight
Lactation
Iron sucrose is present in human milk, and available published reports following exposure to 100-300 mg intravenous iron sucrose have not reported adverse reactions in breastfed infants; there are no data on effects on milk production
Developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for treatment and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin
Pharmacokinetics
Half-life elimination: 6 hr
Vd: 7.9-10 L
Clearance: 1.2 L/hr
Excretion: Urine (5%)
Administration
IV Incompatibilities
Do not mix with other medications or add to parenteral nutrition solutions for IV infusion
IV Compatibilities
Solution: 0.9% NaCl
IV Preparation
Do not dilute to concentrations below 1 mg/mL
Add dose to 0.9% NaCl infusion bags (PVC or non-PVC); final concentrations range is 1-2 mg of elemental iron/mL
Visually inspect for particulate matter and discoloration prior to infusion
Stable for 7 days at controlled room temperature (25°C)
Adults
- HD-dependent and non-dialysis-dependent CKD: Dilute with up to 100 mL of 0.9% NaCl
- PD-dependent CKD: Dilute with up to 250 mL of 0.9% NaCl
Pediatrics
- Dilute in 25 mL of 0.9% NaCl
IV Administration
Adults
HD-dependent CKD
- Undiluted: Administer by slow IV injection over 2-5 min
- Diluted solutions: Administer IV over 15 min
Non-dialysis-dependent CKD
- Undiluted: Administer by slow IV injection over 2-5 min
- Diluted solutions: Administer IV over 15 min
PD-dependent CKD
- 300 mg doses: Infuse IV over 1.5 hr
- 400 mg dose: Infuse IV over 2.5 hr
Pediatric
- Undiluted: Administer by slow IV injection over 5 minutes
- Diluted solutions: Administer IV over 5-60 minutes
Storage
Unused vials
- Store in original carton at 20-25°C (68-77° F); excursions permitted to 15- 30°C (59-86°F)
- Do not freeze
Diluted solutions
- Syringe: Store at room temperature (25°C) or under refrigeration (4°C) for up to 7 days
- IV infusion: Store at room temperature (25°C) for up to 7 days
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Formulary
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