Triferic AVNU (Intravenous)

Ferric pyrophosphate citrate injection is an iron replacement product used to treat iron deficiency anemia (not enough iron in the blood) in patients with dialysis dependent chronic kidney disease (CKD).

Iron is a mineral that the body needs to make red blood cells. When the body does not get enough iron, it cannot make enough normal red blood cells to keep you healthy. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine should only be given by or under the direct supervision of a doctor.

It is very important that your doctor monitors you closely while you are receiving this medicine. Blood tests may be necessary to check for side effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

Make sure your doctor knows if you are also using other iron supplements. Also, inform your doctor if you have had an allergic reaction to injectable iron products.

In deciding to use a medicine, you need to consider the risks versus the benefits. This is a decision you will make with your doctor. For this medicine, the following factors should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have 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 done on how ferric pyrophosphate citrate injection affects children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the use of ferric pyrophosphate citrate injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may adjust the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Baloxavir Marboxil
• Bictegravir
• Dimercaprol
• Eltrombopag
• Erdafitinib
• Magnesium Sulfate
• Raltegravir

Using this medicine with any of the following may increase the 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
• Zinc

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following may increase the 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Anemia that is not caused by iron deficiency or
• Iron overload—Use is not recommended in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, they may require medical attention.

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

More common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when standing up quickly from a lying or sitting position
• sweating
• swelling of the hands, ankles, feet, or lower legs
• trouble breathing
• unusual tiredness or weakness

Less common

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

Rare

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• 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 healthcare professional may be able to provide ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• headache
• muscle spasm
• pain in the arms or legs

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Triferic AVNU

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.