Iron Sucrose

Trade Names:
Venofer
- Injection 20 mg/mL

Pharmacology

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Replenishes Hgb and depleted iron stores.

Pharmacokinetics

Distribution

The apparent Vd is 10 L and the Vd _ss is 7.9 L.

Metabolism

Dissociated into iron and sucrose by the reticuloendothelial system.

Elimination

Sucrose component mainly excreted in the urine. The t _½ is 6 h. The Cl is 1.2 L/h.

Indications and Usage

Treatment of iron deficiency anemia in non-dialysis dependent-chronic kidney disease (CKD) patients either receiving or not receiving an erythropoietin, hemodialysis dependent-CKD patients receiving an erythropoietin, or peritoneal dialysis-CKD patients receiving an erythropoietin.

Contraindications

Iron overload; anemia not caused by iron deficiency; hypersensitivity to any component of product.

Dosage and Administration

IV Either undiluted as a 100 mg slow injection over 2 to 5 min or as an infusion of 100 mg, diluted in a maximum of 100 mL of sodium chloride 0.9% over a period of at least 15 min/consecutive hemodialysis session for a total cumulative 1,000 mg dose.

IV Total cumulative dose of 1,000 mg over a 14day period as a 200 mg slow injection undiluted over 2 to 5 min on 5 different occasions within the 14day period.

IV Total cumulative dose of 1,000 mg in 3 divided doses, given by slow infusion, within a 28day period: 2 infusions of 300 mg over 1.5 h 14 days apart followed by one 400 mg infusion over 2.5 h 14 days later.

General Advice

• Discontinue oral iron preparations before administering parenteral iron products. Coadministration of parenteral iron preparations may reduce absorption of oral iron.
• The dosage is expressed in terms of elemental iron.
• For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration.
• Medication is administered 1 to 3 times/wk. Do not administer more than 3 times/wk.
• For IV infusion in adults, dilute contents of 1 vial in 100 mL sodium chloride 0.9% injection immediately prior to infusion and infuse over 15 min.
• Discard any unused diluted solution. Do not save unused solution for future use.
• Do not administer if particulate matter or discoloration noted.

Storage/Stability

Store vials at controlled room temperature (59° to 86°F). Protect from freezing. Use immediately after dilution in saline.

Drug Interactions

Absorption of oral iron may be reduced.

Incompatibility

Do not mix with other medication or add to parenteral nutrition solutions for IV infusion.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (8%); hypotension (3%); cardiac murmur (2%); congestive cardiac failure (postmarketing).

CNS

Headache (13%); dizziness (7%); fatigue (6%); asthenia (3%); hypoesthesia (2%).

Dermatologic

Pruritus (9%); rash (2%).

EENT

Pharyngitis (7%); conjunctivitis, nasopharyngitis (3%); allergic rhinitis, ear pain, nasal congestion (2%).

GI

Nausea (15%); constipation (13%); diarrhea (10%); vomiting (9%); dysgeusia (8%); abdominal pain (7%).

Genitourinary

UTI (5%).

Lab Tests

Positive fecal occult blood (4%).

Local

Edema (11%); catheter site infection (9%); injection site burning (4%); extravasation, pain (2%).

Metabolic-Nutritional

Hypoglycemia (4%); fluid overload, gout, hyperglycemia (3%).

Musculoskeletal

Muscle cramp (30%); pain in extremity (7%); arthralgia, arthritis, back pain, myalgia (4%).

Respiratory

Dyspnea, sinusitis (4%); cough, upper respiratory tract infection (3%).

Miscellaneous

Peritoneal infection (11%); graft complication (10%); edema (7%); chest pain (6%); feeling abnormal, pyrexia (3%); peripheral edema (at least 2%); anaphylactoid reactions including life-threatening reactions (eg, anaphylactic shock, bronchospasm with dyspnea, convulsion, loss of consciousness or collapse), sepsis (postmarketing).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity.

Hypersensitivity

Potentially fatal hypersensitivity reactions, including anaphylactic shock, may occur.

Hypotension

Hypotension related to the rate of administration and total dose administered may occur.

Iron overload

Exercise caution and withhold iron administration if there is evidence of tissue iron overload.

Overdosage

Symptoms

Abdominal and muscle pain, CV collapse, dizziness, dyspnea, edema, headache, hypotension, joint aches, nausea, paresthesia, vomiting.

Patient Information

• Advise patient that medication will be prepared and administered by health care provider during dialysis sessions and that medication will not be administered at home.
• Instruct patient to immediately inform health care provider if any of the following occur during or shortly after the administration of drug: anxiety; chest, back, flank, or groin pain; itching; lightheadedness; rapid heart beat; rash; shortness of breath or difficulty breathing; sweating; swelling of the throat; weakness.
• Caution patient not to take oral iron supplements while receiving IV iron.

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