Ferrlecit (Ferric Gluconate)

Ferrlecit

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Important Safety Information

Ferrlecit (ferric gluconate) is a prescription infusion medication used to treat iron deficiency anemia in adult patients, as well as pediatric patients who are six years of age and older.

If you receive regular blood transfusions or are pregnant or breastfeeding, please contact your doctor before taking Ferrlecit.

If you are allergic to Ferrlecit or benzyl alcohol, you should not take Ferrlecit.

What is the most important information I should know about Ferrlecit?

Typical Ferrlecit transfusions take at least an hour to complete. Ferrlecit is typically given at the same time as dialysis. The medication may cause adverse reactions when combined with other drugs. Therefore, tell your doctor about all medications you’re currently taking — whether they’re prescription, over-the-counter, herbal supplements, or vitamins.

Do not use Ferrlecit if you have hypersensitivity to sodium ferric gluconate or any of its components. Doing so could result in anaphylaxis. Seek emergency medical care immediately if you experience skin reactions (such as hives, flushed skin, or itching), breathing difficulties, dizziness, a weak or rapid pulse, tightness of the throat, chest pain or tightness, and/or swelling of the tongue, lips, and/or face. Even if your reactions are mild or seem to subside, seeking care can prevent a second wave (biphasic anaphylaxis).

Side Effects of Ferrlecit

Common side effects of Ferrlecit include:

  • Bruising and skin discoloration at the site of injection
  • Nausea, diarrhea, or vomiting
  • Increased heart rate
  • Headache or dizziness
  • Muscle cramps, especially in the legs
  • Increased blood pressure

In some cases, allergic reactions may occur. Symptoms may include:

  • Lower back pain
  • Hives
  • Sweating
  • Weakness and fatigue
  • Shortness of breath
  • Severe pain in chest, groin, back, or sides
  • Sudden redness or flushing

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Adverse Reactions

  • Hypersensitivity – 0.8% of post-marketing patients experienced hypersensitivity reactions, such as anaphylactic and life-threatening conditions. Ferrlecit should only be administered when personnel and therapies are immediately available for treatment of these hypersensitivity conditions.
  • Hypotension – In some cases, Ferrlecit can cause clinical hypertension, as indicated by fatigue, lightheadedness, muscle weakness, etc. Most of these reactions resolve within a couple of hours.
  • Iron Overload – Excessive iron therapy can lead to iatrogenic hemosiderosis. Ferrlecit patients should be monitored during their therapy to make sure iron and hematologic levels are within acceptable limits.

Indications

Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients aged 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.

Please refer to the full prescribing information.