Venofer (iron Sucrose)
Generic Name: venofer (iron sucrose)
Brand Names:
Venofer (iron Sucrose)
11 DESCRIPTION Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide.
Overview
11 DESCRIPTION Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide.
Uses
1 INDICATIONS & USAGE Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
Dosage
2 DOSAGE & ADMINISTRATION Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron. 2.1 Mode of Administration Administer Venofer only intravenously by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] Iron Overload [see Warnings and Precautions ( 5.3 )] 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. Adverse Reactions in Adults Patients with CKD The frequency of adverse reactions associated with the use of Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD.
Interactions
7 DRUG INTERACTIONS Venofer may reduce the absorption of concomitantly administered oral iron preparations.
Warnings
5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer. 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 Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. 4 CONTRAINDICATIONS Known hypersensitivity to Venofer.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-dose vials. Each 10 mL vial contains 200 mg elemental iron, each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL). 16.2 Stability and Storage Contains no preservatives.
Frequently Asked Questions
What is Venofer (iron Sucrose) used for?▼
1 INDICATIONS & USAGE Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
What are the side effects of Venofer (iron Sucrose)?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] Iron Overload [see Warnings and Precautions ( 5.3 )] 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. Adverse Reactions in Adults Patients with CKD The frequency of adverse reactions associated with the use of Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD.
What are the important warnings for Venofer (iron Sucrose)?▼
5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer. 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 Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. 4 CONTRAINDICATIONS Known hypersensitivity to Venofer.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.