VENOFER (IRON SUCROSE)

VENOFER (IRON SUCROSE)- iron sucrose injection, solution
HF Acquisition Co LLC, DBA HealthFirst

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use
VENOFER ® safely and effectively. See full prescribing information for VENOFER.
Venofer (iron sucrose) injection, for intravenous use Initial U.S. Approval: 2000

INDICATIONS AND USAGE

Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )

DOSAGE AND ADMINISTRATION

HIGHLIGHTS
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DOSAGE FORMS AND STRENGTHS

Injection: 50 mg/2.5 mL, 100 mg/5 mL, or 200 mg/10 mL (20 mg/mL) in single-dose vials. ( 3)

CONTRAINDICATIONS

Known hypersensitivity to Venofer ( 4)

WARNINGS AND 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)

ADVERSE REACTIONS

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.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2020

TABLE OF CONTENTS

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Mode of Administration
2.2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
2.3 Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
2.4 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD)
2.5 Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment
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
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Hypotension
5.3 Iron Overload
6 ADVERSE REACTIONS
6.1 Adverse Reactions in Clinical Trials
6.2 Adverse Reactions from Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Studies Overview
14.2 Study A: Hemodialysis Dependent-Chronic Kidney Disease (HDD–CKD)
14.3 Study B: Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
14.4 Study C: Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
14.5 Study D: Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
14.6 Study E: Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD)
14.7 Study F: Iron Maintenance Treatment Dosing in Pediatric Patients Ages 2 Years and Older with Chronic Kidney Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Stability and Storage 17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & USAGE

Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

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.

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.

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