Iron Solution for hemodialysis

What is this medicine?

FERRIC PYROPHOSPHATE CITRATE (FER ik pye roe FOS fate SI trate) ADDITIVE FOR DIALYSIS is an iron replacement that is added to the solution used in hemodialysis machines. It is used to treat low iron levels in patients who are receiving hemodialysis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to ferric pyrophosphate citrate or other iron products, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of urinary tract infection like fever or chills, blood in the urine, pain or trouble passing urine, pain in the lower back or side

• swelling of the ankles, feet, hands

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• headache

• muscle cramps

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Iron Solution for injection

What is this medicine?

SODIUM FERRIC GLUCONATE COMPLEX (SOE dee um FER ik GLOO koe nate KOM pleks) is an iron replacement. It is used with epoetin therapy to treat low iron levels in patients who are receiving hemodialysis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:

• anemia that is not from iron deficiency

• high levels of iron in the body

• an unusual or allergic reaction to iron, benzyl alcohol, other medicines, foods, dyes, or preservatives

• pregnant or are trying to become pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• deferoxamine

• dimercaprol

• other iron products

This medicine may also interact with the following medications:

• chloramphenicol

• deferasirox

• medicine for blood pressure like enalapril

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

Visit your doctor for check-ups as directed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in hearing

• changes in vision

• chills, flushing, or sweating

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever, flu-like symptoms

• high or low blood pressure

• pain, tingling, numbness in the hands or feet

• severe pain in the chest, back, flanks, or groin

• swelling of the ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cramps

• dark colored stools

• diarrhea

• headache

• nausea, vomiting

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.