Sodium Ferric Gluconate Injection

Sodium ferric gluconate injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults and children 6 years of age and older with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) who are on dialysis and are also receiving the medication epoetin (Epogen, Procrit). Sodium ferric gluconate injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.

Sodium ferric gluconate injection comes as a solution (liquid) to inject intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic. It is usually injected over approximately 10 minutes or may be mixed with another fluid and infused over 1 hour. Sodium ferric gluconate injection is usually given during 8 consecutive dialysis sessions for a total of 8 doses. If your iron levels become low after you finish your treatment, your doctor may prescribe this medication again.

Sodium ferric gluconate injection may cause severe or life-threatening reactions during and shortly after you receive the medication. Your doctor will watch you carefully while you receive each dose of sodium ferric gluconate injection and for at least 30 minutes afterwards. Tell your doctor if you experience any of the following symptoms during or after your injection: shortness of breath; wheezing; difficulty swallowing or breathing; hoarseness; facial flushing; swelling of the face, throat, tongue, lips, or eyes; hives; rash; itching; fainting; lightheadedness; dizziness; weakness; severe pain in the chest, back, thighs, or groin; sweating; cold, clammy skin; rapid, weak pulse; slow heartbeat; or loss of consciousness. If you experience a severe reaction, your doctor will stop your infusion immediately and provide emergency medical treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving sodium ferric gluconate injection,

• tell your doctor and pharmacist if you are allergic to sodium ferric gluconate injection, any other medications, benzyl alcohol, or any of the ingredients in sodium ferric gluconate injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements (including oral iron supplements), and herbal products you are taking or plan to take while you are receiving sodium ferric gluconate injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving sodium ferric gluconate injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive sodium ferric gluconate injection, call your doctor as soon as possible.

Sodium ferric gluconate injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• loss of appetite
• stomach pain
• leg cramps
• swelling of the hands, feet, ankles, or lower legs
• headache
• extreme tiredness
• fever
• numbness or tingling
• soreness, redness, or burning at the injection site

Sodium ferric gluconate injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure and order certain lab tests to check your body's response to sodium ferric gluconate injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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