Drug Facts
Composition & Profile
Identifiers & Packaging
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). NDC-0517-2310-05 200 mg/10 mL Single-Dose Vial Packages of 5 NDC-0517-2340-01 100 mg/5 mL Single-Dose Vial Individually Boxed NDC-0517-2340-10 100 mg/5 mL Single-Dose Vial Packages of 10 NDC-0517-2340-25 100 mg/5 mL Single-Dose Vial Packages of 25 NDC-0517-2325-10 50 mg/2.5 mL Single-Dose Vial Packages of 10 16.2 Stability and Storage Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe Stability : Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C). Intravenous Admixture Stability: Venofer, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C). Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.; PRINCIPAL DISPLAY PANEL - 2.5 ML CARTON (10 PACK) NDC 0517-2325-10 10 x 2.5 mL Single-Dose Vials VENOFER ® (Iron Sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL) 2.5 mL Single-Dose Vial - Discard Unused Portion For Intravenous Use Only Rx Only Each 2.5 mL contains: 50 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/2020 2.5 mL Carton; PRINCIPAL DISPLAY PANEL - 5 ML CONTAINER NDC 0517-2340-01 VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) 5 mL Single-Dose Vial Discard Unused Portion For Intravenous Use Only Rx Only Container Label (5 mL); PRINCIPAL DISPLAY PANEL - 5 ML CARTON (1 PACK) NDC 0517-2340-01 5 mL Single-Dose Vial Discard Unused Portion VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) Rx Only For Intravenous Use Only Each 5 mL contains: 100 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. Venofer® is manufactured under license from Vifor (International) Inc., Switzerland. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/2020 5 mL Carton (1 pack); PRINCIPAL DISPLAY PANEL - 5 ML CARTON (10 PACK) NDC 0517-2340-10 10 x 5 mL Single-Dose Vials VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) 5 mL Single-Dose Vial - Discard Unused Portion For Intravenous Use Only Each 5 mL contains: 100 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. Distributed by : AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 8/2024 Venofer 5 mL (10 pack) Carton - updated; PRINCIPAL DISPLAY PANEL - 5 ML CARTON (25 PACK) NDC 0517-2340-25 25 X 5 mL Single-Dose Vials Discard Unused Portion VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) Rx Only For Intravenous Use Only Each 5 mL contains: 100 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. Venofer® is manufactured under license from Vifor (International) Inc., Switzerland. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/2020 5 mL Carton (25 pack); PRINCIPAL DISPLAY PANEL - 10 ML CONTAINER NDC 0517-2310-01 VENOFER ® (Iron Sucrose) Injection, USP 200 mg Elemental Iron per 10 mL (20 mg/mL) 10 mL Single-Dose Vial Discard Unused Portion For Intravenous Use Only Rx Only Container Label (10 mL); PRINCIPAL DISPLAY PANEL - 10 ML CARTON NDC 0517-2310-05 5 x 10 mL Single-Dose Vials VENOFER ® Iron Sucrose Injection, USP 200 mg Elemental Iron per 10 mL (20 mg/mL) 10 mL Single-Dose Vial - Discard Unused Portion For Intravenous Use Only Each 10 mL contains: 200 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 3/2021 10 mL Carton Labeling; Serialization Label - 2325-10 2325-10 Serialization Label; Serialization Label - 2340-01 2340-01 Serialization Label; Serialization Label - 2340-10 2340-10 Serialization Label; Serialization Label - 2340-25 2340-25 Serialization Label; Serialization Label - 2310-05 2310-05 - Serialization Label
- 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). NDC-0517-2310-05 200 mg/10 mL Single-Dose Vial Packages of 5 NDC-0517-2340-01 100 mg/5 mL Single-Dose Vial Individually Boxed NDC-0517-2340-10 100 mg/5 mL Single-Dose Vial Packages of 10 NDC-0517-2340-25 100 mg/5 mL Single-Dose Vial Packages of 25 NDC-0517-2325-10 50 mg/2.5 mL Single-Dose Vial Packages of 10 16.2 Stability and Storage Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe Stability : Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C). Intravenous Admixture Stability: Venofer, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C). Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.
- PRINCIPAL DISPLAY PANEL - 2.5 ML CARTON (10 PACK) NDC 0517-2325-10 10 x 2.5 mL Single-Dose Vials VENOFER ® (Iron Sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL) 2.5 mL Single-Dose Vial - Discard Unused Portion For Intravenous Use Only Rx Only Each 2.5 mL contains: 50 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/2020 2.5 mL Carton
- PRINCIPAL DISPLAY PANEL - 5 ML CONTAINER NDC 0517-2340-01 VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) 5 mL Single-Dose Vial Discard Unused Portion For Intravenous Use Only Rx Only Container Label (5 mL)
- PRINCIPAL DISPLAY PANEL - 5 ML CARTON (1 PACK) NDC 0517-2340-01 5 mL Single-Dose Vial Discard Unused Portion VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) Rx Only For Intravenous Use Only Each 5 mL contains: 100 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. Venofer® is manufactured under license from Vifor (International) Inc., Switzerland. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/2020 5 mL Carton (1 pack)
- PRINCIPAL DISPLAY PANEL - 5 ML CARTON (10 PACK) NDC 0517-2340-10 10 x 5 mL Single-Dose Vials VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) 5 mL Single-Dose Vial - Discard Unused Portion For Intravenous Use Only Each 5 mL contains: 100 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. Distributed by : AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 8/2024 Venofer 5 mL (10 pack) Carton - updated
- PRINCIPAL DISPLAY PANEL - 5 ML CARTON (25 PACK) NDC 0517-2340-25 25 X 5 mL Single-Dose Vials Discard Unused Portion VENOFER ® (Iron Sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL) Rx Only For Intravenous Use Only Each 5 mL contains: 100 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. Venofer® is manufactured under license from Vifor (International) Inc., Switzerland. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/2020 5 mL Carton (25 pack)
- PRINCIPAL DISPLAY PANEL - 10 ML CONTAINER NDC 0517-2310-01 VENOFER ® (Iron Sucrose) Injection, USP 200 mg Elemental Iron per 10 mL (20 mg/mL) 10 mL Single-Dose Vial Discard Unused Portion For Intravenous Use Only Rx Only Container Label (10 mL)
- PRINCIPAL DISPLAY PANEL - 10 ML CARTON NDC 0517-2310-05 5 x 10 mL Single-Dose Vials VENOFER ® Iron Sucrose Injection, USP 200 mg Elemental Iron per 10 mL (20 mg/mL) 10 mL Single-Dose Vial - Discard Unused Portion For Intravenous Use Only Each 10 mL contains: 200 mg elemental iron (as iron sucrose) in water for injection. The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. Osmolarity 1,250 mOsmol/L. Contains no preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sterile. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 3/2021 10 mL Carton Labeling
- Serialization Label - 2325-10 2325-10 Serialization Label
- Serialization Label - 2340-01 2340-01 Serialization Label
- Serialization Label - 2340-10 2340-10 Serialization Label
- Serialization Label - 2340-25 2340-25 Serialization Label
- Serialization Label - 2310-05 2310-05 - Serialization Label
Overview
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: [Na 2 Fe 5 O 8 (OH) ·3(H 2 O)] n ·m(C 12 H 22 O 11 ) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.
Indications & Usage
Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )
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. Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD-CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion 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. 2.2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session [see How Supplied/Storage and Handling ( 16.2 ).] Administer Venofer early during the dialysis session (generally within the first hour). The usual total treatment course of Venofer is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs. 2.3 Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Administer Venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Venofer, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on Day 1 and Day 14 [see How Supplied/Storage and Handling ( 16.2 ).] Venofer treatment may be repeated if iron deficiency reoccurs. 2.4 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) Administer Venofer in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Venofer in a maximum of 250 mL of 0.9% NaCl [see How Supplied/Storage and Handling ( 16.2 ).] Venofer treatment may be repeated if iron deficiency reoccurs. 2.5 Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL [see How Supplied/Storage and Handling [ 16.2 ].) Venofer treatment may be repeated if necessary. The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established. 2.6 Pediatric Patients (2 Years of Age and Older) with NDD-CKD or PDD-CKD who are on Erythropoietin Therapy for Iron Maintenance Treatment For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL [see How Supplied/Storage and Handling ( 16.2 ).] Venofer treatment may be repeated if necessary. The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.
Warnings & Precautions
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration. ( 5.2 ) Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer to patients with iron overload. ( 5.3 ) 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. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion [see Adverse Reactions ( 6.1 and 6.2 )]. 5.2 Hypotension Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to the rate of administration and/or total dose administered [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.2 )]. 5.3 Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing [see Dosage and Administration ( 2 ) and Overdosage ( 10 )].
Contraindications
Known hypersensitivity to Venofer. Known hypersensitivity to Venofer ( 4 )
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 )] Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 ) Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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. Adverse reactions reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Venofer exceeds the rate for comparator are listed by indication in Table 1. Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered. Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks. Table 1. Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator * EPO=Erythropoietin Body System/Adverse Reactions HDD-CKD NDD-CKD PDD-CKD Venofer Venofer Oral Iron Venofer EPO* Only (N=231) (N=139) (N=139) (N=75) (N=46) % % % % % Subjects with any adverse reaction 78.8 76.3 73.4 72.0 65.2 Ear and Labyrinth Disorders Ear Pain 0 2.2 0.7 0 0 Eye Disorders Conjunctivitis 0.4 0 0 2.7 0 Gastrointestinal Disorders Abdominal pain 3.5 1.4 2.9 4.0 6.5 Diarrhea 5.2 7.2 10.1 8.0 4.3 Dysgeusia 0.9 7.9 0 0 0 Nausea 14.7 8.6 12.2 5.3 4.3 Vomiting 9.1 5.0 8.6 8.0 2.2 General Disorders and Administration Site Conditions Asthenia 2.2 0.7 2.2 2.7 0 Chest pain 6.1 1.4 0 2.7 0 Feeling abnormal 3.0 0 0 0 0 Infusion site pain or burning 0 5.8 0 0 0 Injection site extravasation 0 2.2 0 0 0 Peripheral edema 2.6 7.2 5.0 5.3 10.9 Pyrexia 3.0 0.7 0.7 1.3 0 Infections and Infestations Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis 2.6 2.2 4.3 16.0 4.3 Injury, Poisoning and Procedural Complications Graft complication 9.5 1.4 0 0 0 Metabolism and Nutrition Disorders Fluid overload 3.0 1.4 0.7 1.3 0 Gout 0 2.9 1.4 0 0 Hyperglycemia 0 2.9 0 0 2.2 Hypoglycemia 0.4 0.7 0.7 4.0 0 Musculoskeletal and Connective Tissue Disorders Arthralgia 3.5 1.4 2.2 4.0 4.3 Back pain 2.2 2.2 3.6 1.3 4.3 Muscle cramp 29.4 0.7 0.7 2.7 0 Myalgia 0 3.6 0 1.3 0 Pain in extremity 5.6 4.3 0 2.7 6.5 Nervous System Disorders Dizziness 6.5 6.5 1.4 1.3 4.3 Headache 12.6 2.9 0.7 4.0 0 Respiratory, Thoracic and Mediastinal Disorders Cough 3.0 2.2 0.7 1.3 0 Dyspnea 3.5 5.8 1.4 1.3 2.2 Nasal congestion 0 1.4 2.2 1.3 0 Skin and Subcutaneous Tissue Disorders Pruritus 3.9 2.2 4.3 2.7 0 Vascular Disorders Hypertension 6.5 6.5 4.3 8.0 6.5 Hypotension 39.4 2.2 0.7 2.7 2.2 One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had prior other intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Venofer there were no occurrences of adverse reactions that precluded further use of Venofer [see Warning and Precautions ( 5 )]. Adverse Reactions in Pediatric Patients with CKD (ages 2 years and older) In a randomized, open-label, dose-ranging trial for iron maintenance treatment with Venofer in pediatric patients with CKD on stable erythropoietin therapy [see Clinical Studies ( 14.7 )] , at least one adverse reaction was experienced by 57% (27/47) of the patients receiving Venofer 0.5 mg/kg, 53% (25/47) of the patients receiving Venofer 1 mg/kg, and 55% (26/47) of the patients receiving Venofer 2 mg/kg. A total of 5 (11%) subjects in the Venofer 0.5 mg/kg group, 10 (21%) patients in the Venofer 1 mg/kg group, and 10 (21%) patients in the Venofer 2 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common adverse reactions (>2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%). 6.2 Adverse Reactions from Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Venofer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by >1% were cardiac failure congestive, sepsis and dysgeusia. Immune system disorders: anaphylactic-type reactions, angioedema Psychiatric disorders: confusion Nervous system disorders: convulsions, collapse, light-headedness, loss-of-consciousness Cardiovascular System : bradycardia, shock, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction 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 Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection. Reactions have occurred following the first dose or subsequent doses of Venofer. Symptoms may respond to intravenous fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms. Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.
Drug Interactions
Venofer may reduce the absorption of concomitantly administered oral iron preparations.
Storage & Handling
16.2 Stability and Storage Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe Stability : Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C). Intravenous Admixture Stability: Venofer, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C). Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.