Venofer injection

• Known hypersensitivity to Venofer

The following serious adverse reactions associated with Venofer are described in other sections [See Warnings and Precautions (5.1, 5.2 and 5.3)].

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 Adult 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. Treatment-emergent 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.

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 (14.6)], at least one treatment-emergent 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 1.0 mg/kg, and 55% (26/47) of the patients receiving Venofer 2.0 mg/kg.

A total of 5 (11%) subjects in the Venofer 0.5 mg/kg group, 10 (21%) patients in the Venofer 1.0 mg/kg group, and 10 (21%) patients in the Venofer 2.0 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common treatment-emergent 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%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).

Adverse Reactions from Post-Marketing Experience

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.

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: Anaphylactic-type reactions, shock, loss of consciousness, collapse, bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, back pain, bradycardia, and chromaturia.

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.

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.

Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-use vials (200 mg elemental iron per 10 mL), 5 mL single-use vials (100 mg elemental iron per 5 mL), and 2.5 mL single-use vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.

NDC 0517-2325-10

10 x 2.5 mL Single-Use Vials

VENOFER®
(IRON SUCROSE INJECTION, USP)

50 mg Elemental Iron per 2.5 mL (20 mg/mL)

2.5 mL Single-Use 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).  pH 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. 10/12

VENOFER 2.5 ML CARTON (10 PACK)

NDC 0517-2340-01

VENOFER®
(IRON SUCROSE INJECTION, USP)

100 mg Elemental Iron per 5 mL (20 mg/mL)

5 mL Single-Use Vial

Discard Unused Portion 

FOR INTRAVENOUS USE ONLY

Rx Only

VENOFER 5 ML CONTAINER (1 PACK)

NDC 0517-2340-25

25 X 5 mL Single-Use 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). pH 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. 10/12 

VENOFER 5 ML CARTON (25 PACK)

You should not be treated with Venofer if you have ever had an allergic reaction to an iron injection.

To make sure Venofer is safe for you, tell your doctor if you have:

• iron overload (the buildup of excess iron), or hemochromatosis.

Venofer injection is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether iron sucrose passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction to Venofer: hives, itching; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• chest pain;

• a light-headed feeling, like you might pass out; or

• increased blood pressure (severe headache, pounding in your neck or ears, anxiety, confusion).

Common Venofer side effects may include:

• headache, dizziness;

• nausea, vomiting;

• diarrhea;

• muscle or joint pain, back pain;

• pain in an arm or leg;

• itching; or

• bruising or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Common side effects of Venofer include: hypotension. See below for a comprehensive list of adverse effects.