Venofer

Dosage Forms & Strengths

injectable solution

• 20mg (Fe)/mL

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia associated with chronic kidney disease

Hemodialysis-dependent CKD: 100 mg elemental iron IV (injection or infusion over 2-5 min) per dialysis session not to exceed total cumulative dose of 1000 mg divided in 3 doses/week

Non-dialysis-dependent CKD: 200 mg IV injection for 5 doses in over 14 days (cumulative 1000 mg in 14-day period)

Peritoneal dialysis-dependent CKD: 300 mg IV infusion (1.5 hr) for 2 doses 14 days apart, THEN 400 mg IV infusion (2.5 hr) 14 days later (cumulative 1000 mg divided in 3 doses/week)

Dosage Forms & Strengths

injectable solution

• 20mg (Fe)/mL

Iron Deficiency Anemia

Indicated for maintenance treatment of iron-deficient anemia associated with chronic kidney disease

<2 years: Safety and efficacy not established

≥2 years

• Hemodialysis-dependent: 0.5 mg/kg IV q2weeks for 12 weeks; not to exceed 100 mg/dose
• Non-dialysis dependent or peritoneal-dependent (on erythropoietin): 0.5 mg/kg IV q4weeks for 12 weeks; not to exceed 100 mg/dose

Iron sucrose is given as an injection through a needle placed into a vein or directly into a dialysis line. You will receive this injection in a clinic, hospital, or dialysis setting.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when iron sucrose is injected.

You will be watched closely for at least 30 minutes after receiving an iron sucrose injection, to make sure you do not have an allergic reaction to the medicine.

You may need frequent medical tests to help your doctor determine how long to treat you with iron sucrose.

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

Call your doctor for instructions if you miss an appointment for your iron sucrose injection.

Dosage Forms And Strengths

• 10 mL single-use vial / 200 mg elemental iron (20 mg/mL)
• 5 mL single-use vial / 100 mg elemental iron (20 mg/mL)
• 2.5 mL single-use vial / 50 mg elemental iron (20 mg/mL)

Storage And Handling

Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use 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-Use Vial Packages of 5
NDC-0517-2310-10 200 mg/10 mL Single-Use Vial Packages of 10
NDC-0517-2340-01 100 mg/5 mL Single-Use Vial Individually Boxed
NDC-0517-2340-10 100 mg/5 mL Single-Use Vial Packages of 10
NDC-0517-2340-25 100 mg/5 mL Single-Use Vial Packages of 25
NDC-0517-2340-99 100 mg/5 mL Single-Use Vial Packages of 10
NDC-0517-2325-10 50 mg/2.5 mL Single-Use Vial Packages of 10
NDC-0517-2325-25 50 mg/2.5 mL Single-Use Vial Packages of 25

Contains no preservatives. Store in original carton at 20° to 25°C (68° 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.

Venofer is manufactured under license from Vifor (International) Inc., Switzerland. Revised: Aug 2015

Included as part of the PRECAUTIONS section.

You should not receive this medication if you have ever had an allergic reaction to an iron injection, or if you have iron overload (the buildup of excess iron) or hemochromatosis.

Before you receive iron sucrose injection, tell your doctor if you have low blood pressure, hepatitis, or if you have received many blood transfusions in the past.

Iron sucrose injection can make it harder for your body to absorb iron medications you take by mouth. Tell your doctor if you are taking iron supplements or other iron-based oral medications.

• Has pharmacologic actions similar to those of other parenteral iron preparations (e.g., iron dextran, sodium ferric gluconate).1 4

• Iron sucrose is free of ferrous ions and dextran polysaccharides, which are believed to be antigenic stimuli for anaphylactic reactions.5 7 8

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In the U.S.

• Venofer

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Mineral-Trace Mineral

It is very important that your doctor check you closely while you are receiving this medicine. Blood tests may be needed to check for unwanted effects. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin using this medicine, or when the dose is increased.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Very bad dizziness or passing out.
• Very bad headache.
• Shortness of breath.
• Swelling in the arms or legs.
• Irritation where the shot is given.