iron sucrose (Rx)

>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

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

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.

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%)

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