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Sodium ferric gluconate complex (Injection)

Sodium Ferric Gluconate Complex (SOE-dee-um FER-rik Gloo-koe-nate KOM-plex)

Treats iron deficiency anemia (not enough iron in the blood) in patients with chronic kidney disease (CKD) receiving dialysis and are also receiving medicines (such as erythropoietin) to increase red blood cells.

Brand Name(s):

Ferrlecit, Novaplus Sodium Ferric Gluconate Complex Sucrose

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you have had an allergic reaction to sodium ferric gluconate or to any iron-containing products, or if you have anemia that is not caused by iron deficiency.

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
  • A nurse or other health provider will give you this medicine.

If a dose is missed:

  • This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor or dialysis clinic or doctor for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also taking a multivitamin or an iron supplement.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have ever been treated for any blood disorder. Tell your doctor if you have kidney disease, liver disease, heart problems, low blood pressure, or a condition called iron overload.
  • 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 or your child have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this 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 or your child begin using this medicine, or when the dose is increased.
  • This medicine contains benzyl alcohol which may cause serious reactions (such as gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Back, side, or groin pain.
  • Chest pain, shortness of breath, or coughing up blood.
  • Confusion, body weakness, or numbness or tingling in your hands, feet, or lips.
  • Decrease in how much or how often you urinate, or have burning or painful urination.
  • Fast, slow, pounding, or uneven heartbeats.
  • Lightheadedness, dizziness, or fainting.
  • Numbness or weakness in your arm or leg, or on one side of your body.
  • Pain in your lower leg (calf) or leg swelling.
  • Sudden or severe headache, or new problems with vision, speech, or walking.
  • Swelling in your hands, ankles, or feet.
  • Troubled breathing or wheezing.
  • Unexplained sweating, chills, fever, or flu-like symptoms.
  • Unusual bleeding, bruising, or weakness.
  • Warmth or redness in your face, neck, arms, or upper chest.

If you notice these less serious side effects, talk with your doctor:

  • Headache.
  • Nausea, vomiting, diarrhea, loss of appetite, or stomach pain.
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
  • Rash or itching skin.
  • Sleepiness or unusual drowsiness.
  • Trouble sleeping.
  • Weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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


Last Updated: 9/4/2014


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