Ferric pyrophosphate citrate Route Not Applicable

In the U.S.

• Triferic

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Iron Supplement

Ferric pyrophosphate citrate is used as an iron replacement to prevent anemia in patients with chronic kidney disease who are on dialysis.

ferric pyrophosphate citrate is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ferric pyrophosphate citrate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ferric pyrophosphate citrate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ferric pyrophosphate citrate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ferric pyrophosphate citrate in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving ferric pyrophosphate citrate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ferric pyrophosphate citrate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dimercaprol
• Eltrombopag

Using ferric pyrophosphate citrate with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Delafloxacin
• Minocycline
• Mycophenolic Acid
• Zinc

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ferric pyrophosphate citrate with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ferric pyrophosphate citrate, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

A doctor or other healthcare professional will give you ferric pyrophosphate citrate in a dialysis clinic or hospital. ferric pyrophosphate citrate is added to the dialysis solution.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• rapid weight gain
• sweating
• tingling of the hands or feet
• trouble breathing
• unusual tiredness or weakness
• unusual weight gain or loss

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• lower back or side pain

• Cough
• difficulty with breathing or swallowing
• hives, itching, or skin rash
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• muscle spasms
• pain in the arms or legs

• Back pain
• lack or loss of strength

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: