Class: Iron Preparations
Chemical Name: iron saccharate
CAS Number: 8047-67-4
Brands: Venofer
Hematinic agent; a polynuclear iron (III)-hydroxide sucrose complex.
Uses for Iron Sucrose
Iron Deficiency Anemia in Patients with Chronic Kidney Disease
Treatment of iron deficiency anemia in patients with chronic kidney disease (CKD), including those who are undergoing dialysis (hemodialysis or peritoneal) and those who do not require dialysis.
In patients with CKD on hemodialysis, IV iron superior to orally administered iron in increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route of iron administration is preferred in such patients.
Available data suggest that iron sucrose and sodium ferric gluconate may be associated less frequently with serious adverse effects (e.g., hypersensitivity reactions) than iron dextran.
Iron sucrose injection also used as iron maintenance therapy in children with dialysis-dependent (hemodialysis or peritoneal dialysis) or non-dialysis-dependent CKD. (See Pediatric Use under Cautions.)
Iron Sucrose Dosage and Administration
General
- Although manufacturer makes no specific recommendations regarding test doses, test doses of iron sucrose (20–25 or 50 mg) have been administered in some patients. (See Sensitivity Reactions under Cautions.)
- Ensure immediate availability of personnel trained to provide emergency treatment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction when administering iron sucrose injection.
Administration
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer (diluted) by IV infusion or (undiluted) by slow IV injection.
Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion.
Dilution
For IV infusion, dilute in 0.9% sodium chloride injection; specific recommendations for dilution vary depending on the intended patient population (see Dosage). Do not dilute to concentrations <1 mg/mL.
Dosage
Dosage expressed in terms of mg of elemental iron. Iron sucrose injection contains the equivalent of 20 mg of elemental iron per mL.
Pediatric Patients
Iron Maintenance Treatment in Patients with Hemodialysis-dependent CKD
IV
Children ≥2 years of age: 0.5 mg/kg (not to exceed 100 mg per dose) every 2 weeks for 12 weeks; may administer undiluted by slow IV injection over 5 minutes or diluted in 25 mL of 0.9% sodium chloride injection over 5–60 minutes.
Repeat treatment if necessary.
Iron Maintenance Treatment in Patients with Non-dialysis-dependent CKD Receiving ESAs
IV
Children ≥2 years of age: 0.5 mg/kg (not to exceed 100 mg per dose) every 4 weeks for 12 weeks; may administer undiluted by slow IV injection over 5 minutes or diluted in 25 mL of 0.9% sodium chloride injection over 5–60 minutes.
Repeat treatment if necessary.
Iron Maintenance Treatment in Patients with Peritoneal Dialysis-dependent CKD Receiving ESAs
IV
Children ≥2 years of age: 0.5 mg/kg (not to exceed 100 mg per dose) every 4 weeks for 12 weeks; may administer undiluted by slow IV injection over 5 minutes or diluted in 25 mL of 0.9% sodium chloride injection over 5–60 minutes.
Repeat treatment if necessary.
Adults
Patients with Hemodialysis-dependent CKD
IV
100 mg by slow IV injection (over 2–5 minutes) or by IV infusion (diluted in a maximum of 100 mL of 0.9% sodium chloride injection and administered over at least 15 minutes) during each consecutive hemodialysis session. Administer early during dialysis procedure.
A cumulative dose of 1 g of iron sucrose usually is required.
Repeat treatment if necessary.
Patients with Non-dialysis-dependent CKD
IV
200 mg by slow IV injection (over 2–5 minutes) or IV infusion (diluted in a maximum of 100 mL of 0.9% sodium chloride injection and administered over 15 minutes) for a total of 5 doses; administer the doses on 5 different occasions over a 14-day period.
Also has been administered in a dosage of 500 mg by IV infusion (diluted in a maximum of 250 mL of 0.9% sodium chloride injection) on days 1 and 14; administer each dose over 3.5–4 hours.
Repeat treatment if necessary.
Patients with Peritoneal Dialysis-dependent CKD
IV
Administer a series of 3 doses, each dose spaced 14 days apart, over 28 days. For the first 2 doses, administer 300 mg by IV infusion (diluted in a maximum of 250 mL of 0.9% sodium chloride injection and administered over 1.5 hours); follow with a dose of 400 mg (diluted in a maximum of 250 mL of 0.9% sodium chloride injection and administered over 2.5 hours).
Repeat treatment if necessary.
Prescribing Limits
Pediatric Patients
IV
Do not exceed 100 mg per dose.
Special Populations
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and/or other drug therapies.
Cautions for Iron Sucrose
Contraindications
- Known hypersensitivity to iron sucrose or any ingredient in the formulation.
Warnings/Precautions
Warnings
Sensitivity Reactions
Hypersensitivity reactions, including anaphylactic shock, loss of consciousness, collapse, hypotension, dyspnea, and seizures have been reported; sometimes fatal. Immediately discontinue drug and obtain medical attention if symptoms of hypersensitivity or drug intolerance occur. Monitor patients for at least 30 minutes after completion of infusions. (See Dosage and Administration.)
Cardiovascular Effects
Possible hypotension associated with IV administration; may be minimized by adhering to recommended total doses and rates of administration. (See Dosage and Administration.)
General Precautions
Iron Toxicity
Do not administer in patients with evidence suggesting iron overload because body iron excretion is limited and excessive iron in tissues can be hazardous. Periodically monitor laboratory values indicative of iron storage in the body (e.g., transferrin saturation, serum ferritin concentrations, hemoglobin, hematocrit) to detect iron accumulation.
Specific Populations
Pregnancy
Category B.
Lactation
Not known whether iron sucrose is distributed into milk; use caution in nursing women.
Pediatric Use
Efficacy and safety for iron maintenance therapy established in pediatric patients ≥2 years of age with dialysis-dependent or non-dialysis-dependent CKD.
Safety and efficacy for iron replacement therapy in pediatric patients with CKD not established.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; use caution in dosage selection and adjustment.
Concomitant Disease States
Clinical studies generally excluded patients with serious underlying disease, inflammatory conditions, or active infections; use with caution.
Common Adverse Effects
Diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, extremity pain, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, peripheral edema.
Interactions for Iron Sucrose
Oral Iron Preparations
No formal drug interaction studies to date.
Like other parenteral iron preparations, iron sucrose injection may be expected to reduce absorption of concomitantly administered oral iron.
Iron Sucrose Pharmacokinetics
Distribution
Extent
Distributed into liver, spleen, and bone marrow.
Elimination
Metabolism
Following IV administration, dissociated into iron and sucrose by the reticuloendothelial system.
Elimination Route
Sucrose component is eliminated mainly by urinary excretion.
Half-life
6 hours.
Special Populations
Serum clearance of iron expected to be more rapid in iron-deficient patients than in healthy individuals.
Stability
Storage
Parenteral
Injection
20–25°C (may be exposed to 15–30°C); do not freeze.
When diluted with 0.9% sodium chloride injection at concentrations of 2–10 mg of elemental iron per mL and stored in a plastic syringe, stable for 7 days at controlled room temperature (25 ± 2°C) or under refrigeration (4 ± 2°C).
When stored undiluted in a plastic syringe at a concentration of 20 mg of elemental iron per mL, stable for 7 days at 25 ± 2°C or 4 ± 2°C.
When added to IV infusion bags containing 0.9% sodium chloride injection at concentrations of 1–2 mg of elemental iron per mL, stable for 7 days at 25 ± 2°C.
Contains no preservatives; use immediately after opening vial(s).
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Iron sucrose injection should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.
Actions
- Has pharmacologic actions similar to those of other parenteral iron preparations (e.g., iron dextran, sodium ferric gluconate).
- Iron sucrose is free of ferrous ions and dextran polysaccharides, which are believed to be antigenic stimuli for anaphylactic reactions.
Advice to Patients
- Risk of potentially fatal sensitivity (e.g., anaphylactoid) reactions.
- Risk of hypotension.
- Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
- Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
- Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
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Iron Sucrose |
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Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
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Parenteral |
For injection, for IV infusion |
equivalent to 20 mg/mL of elemental iron |
Venofer |
American Regent |