Sodium ferric gluconate complex

Sodium ferric gluconate is a type of iron. You usually get iron from the foods you eat. In your body, iron becomes part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to your tissues and organs. Myoglobin helps your muscle cells store oxygen.

Sodium ferric gluconate complex is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body) in adults and children who are at least 6 years old. Sodium ferric gluconate complex is for people with kidney disease who are on dialysis.

Sodium ferric gluconate complex may also be used for purposes not listed in this medication guide.

Sodium ferric gluconate complex is given as an infusion into a vein during your dialysis session. This medicine must be given slowly, and the infusion can take at least 1 hour to complete.

You will need frequent medical tests.

Follow all instructions on your medicine label and package. Inform every one of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

You should not use sodium ferric gluconate complex if you are allergic to sodium ferric gluconate complex or benzyl alcohol.

Sodium ferric gluconate complex is not approved for anyone younger than 6 years old. Sodium ferric gluconate complex may have an ingredient that can cause serious side effects or death in very young or premature babies.

Tell your doctor if you have ever had:

• iron overload syndrome; or
• if you receive regular blood transfusions.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, sweating, vomiting; severe lower back pain; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may happen within 30 minutes after an injection. Tell your caregiver if you feel dizzy, nauseous, light-headed, itchy, or sweaty.

Sodium ferric gluconate complex may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, like you might pass out;
• swelling, rapid weight gain;
• feeling very weak or tired;
• shortness of breath;
• severe pain in your chest, back, sides, or groin; or
• flushing (sudden warmth, redness, or tingly feeling).

Common side effects of sodium ferric gluconate complex may include:

• bruising or skin discoloration where an injection was given;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• fast heartbeats;
• chest pain, trouble breathing;
• pain, leg cramps;
• increased blood pressure; or
• abnormal blood tests.

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.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

10 mL in 100 mL 0.9% sodium chloride IV over 1 hour per dialysis sessionOR10 mL (125 mg elemental iron) undiluted slow IV (up to 12.5 mg elemental iron/min) per dialysis sessionComments:-Most patients require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions.-Administer during the dialysis session itself.-Doses over 125 mg elemental iron may have higher incidence or severity of adverse events.Use: Treatment of iron deficiency anemia in patients with chronic kidney disease receiving hemodialysis who are receiving epoetin therapy.

Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure:

6 years and older: 0.12 mL/kg (1.5 mg/kg elemental iron) diluted in 25 mL 0.9% sodium chloride IV over 1 hour per dialysis sessionMaximum dose: 125 mg elemental iron per doseComments:-Administer during the dialysis session itself.-Doses over 125 mg elemental iron may have higher incidence or severity of adverse events.Use: Treatment of iron deficiency anemia in patients with chronic kidney disease receiving hemodialysis who are receiving epoetin therapy.

Since sodium ferric gluconate complex is given during dialysis, sodium ferric gluconate complex does not have a separate dosing schedule.

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

• Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Tell your doctor about all the other medicines you are taking, especially iron supplements. Sodium ferric gluconate complex can make it harder for your body to absorb iron supplements you take by mouth.

Other drugs may affect sodium ferric gluconate complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medicines and any medicine you begin or stop using.