Venofer

DRUG 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 (Ill)-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.

What are the possible side effects of iron sucrose injection (Venofer)?

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

Tell your caregivers right away if you have a serious side effect such as:

  • chest pain;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • trouble breathing; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion,...

Read All Potential Side Effects and See Pictures of Venofer

What are the precautions when taking iron sucrose injection (Venofer)?

Before using iron sucrose, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Venofer


Venofer Consumer (continued)

SIDE EFFECTS: Muscle cramps, nausea, vomiting, strange taste in the mouth, diarrhea, constipation, headache, cough, back pain, joint pain, dizziness, or swelling of the arms/legs may occur. Pain, swelling, or redness at the injection site may occur. If these effects continue or worsen, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Severe dizziness or fainting (hypotension) may occur while you are receiving IV iron. This may be helped by giving the medication more slowly or at a lower dose. Follow your doctor's directions carefully.

Tell your doctor right away if you have any serious side effects, including: abdominal pain, chest pain, irregular heartbeat (arrhythmias), pressure in the chest, severe headache and blurred vision (hypertension), problems with your dialysis access site (graft).

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using iron sucrose, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Venofer Patient Information Including Side Effects

Brand Names: Venofer

Generic Name: iron sucrose (injection) (Pronunciation: EYE urn SOO krose)

  • What is iron sucrose injection (Venofer)?
  • What are the possible side effects of iron sucrose injection (Venofer)?
  • What is the most important information I should know about iron sucrose injection (Venofer)?
  • What should I discuss with my healthcare provider before I receive iron sucrose injection (Venofer)?
  • How should I use iron sucrose injection (Venofer)?
  • What happens if I miss a dose (Venofer)?
  • What happens if I overdose (Venofer)?
  • What should I avoid while using iron sucrose injection (Venofer)?
  • What other drugs will affect iron sucrose injection (Venofer)?
  • Where can I get more information?

What is iron sucrose injection (Venofer)?

Iron sucrose is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Iron sucrose injection is used to treat iron deficiency anemia in people with kidney disease. It is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit).

This medication is not for treating other forms of anemia not caused by iron deficiency.

Iron sucrose injection may also be used for other purposes not listed in this medication guide.

What are the possible side effects of iron sucrose injection (Venofer)?

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

Tell your caregivers right away if you have a serious side effect such as:

  • chest pain;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • trouble breathing; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • muscle cramps;
  • weakness, tired feeling;
  • dizziness, anxiety, headache;
  • nausea, vomiting, stomach pain;
  • diarrhea, constipation;
  • ear pain;
  • sore throat, sinus pain or congestion;
  • decreased sense of taste;
  • joint pain; or
  • pain, swelling, burning, or irritation around the IV needle.

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.

What is the most important information I should know about iron sucrose injection (Venofer)?

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.

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