Ferric pyrophosphate is an iron replacement product. You normally get iron from the foods you eat. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs.

Ferric pyrophosphate is used to treat iron deficiency in people with chronic kidney disease who are on dialysis.

Ferric pyrophosphate may also be used for purposes not listed in this medication guide.

You should not use ferric pyrophosphate if you have ever had a severe allergic reaction to any injected iron product.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ferric pyrophosphate.

Ferric pyrophosphate is added directly to the dialyzer fluid and given during hemodialysis.

You will be watched closely to make sure you do not have an allergic reaction.

A healthcare provider will give you this injection. Ferric pyrophosphate is not for use with home hemodialysis.

You will need frequent medical tests.

Usual Adult Dose for hemodialysis:

Add to bicarbonate concentrate for a 2 micromolar (110 mcg/L) concentration of iron (III) in the final hemodialysate

Comments:
-This drug is not intended for use in peritoneal dialysis.
-This drug has not been studied in home hemodialysis.

Use: Replacement of iron to maintain hemoglobin in hemodialysis-dependent kidney disease (HDD-CKD)

Usual Adult Dose for Iron Deficiency:

Add to bicarbonate concentrate for a 2 micromolar (110 mcg/L) concentration of iron (III) in the final hemodialysate

Comments:
-This drug is not intended for use in peritoneal dialysis.
-This drug has not been studied in home hemodialysis.

Use: Replacement of iron to maintain hemoglobin in hemodialysis-dependent kidney disease (HDD-CKD)

You should not use ferric pyrophosphate if you have ever had a severe allergic reaction to any injected iron product.

Tell your doctor if you have ever had:

• liver disease; or

• high blood pressure.

Ferric pyrophosphate may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 2 weeks after your last dose.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Because you will receive ferric pyrophosphate with your hemodialysis, you are not likely to miss a dose.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Ferric pyrophosphate may cause serious side effects. Call your doctor at once if you have:

• bleeding around your dialysis vein access point;

• blue-colored skin, bulging purple-colored veins that you can see through your skin;

• swelling in your arms, legs, or fingers;

• unusual bleeding or bruising, coughing up blood;

• a light-headed feeling, like you might pass out;

• fever; or

• pain or burning when you urinate.

Common side effects of ferric pyrophosphate may include:

• headache, dizziness;

• swelling in your hands or feet;

• weakness, tiredness;

• muscle pain;

• feeling short of breath; or

• pain in your back, arms, or legs.

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.

Other drugs may affect ferric pyrophosphate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.