Uses

Sucroferric oxyhydroxide is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels.

Sucroferric oxyhydroxide contains a form of iron which is not absorbed by your body. It works by binding to phosphate in your diet. The phosphate then passes out of your body in your stool.

How To Use

See also Drug Interactions section.

Take this medication by mouth as directed by your doctor, usually 3 times daily, with or right after a meal. Chew thoroughly before swallowing each dose. You may crush the tablets to make it easier to chew them. Do not swallow the tablets whole. This medication does not need to be swallowed with water.

Use this medication regularly to get the most benefit from it. The dosage is based on your medical condition and response to treatment.

Side Effects

Nausea or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

The iron in this medication may cause your stools to turn black. This effect is harmless.

This medication may stain your teeth. You may also notice an unusual taste from the medication.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking sucroferric oxyhydroxide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• stomach/intestinal problems
• liver problems
• high level of iron in the blood
• problems chewing tablets

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication.

It is unknown if this medication passes into breast milk. However, it is unlikely to pass into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• levothyroxine

Sucroferric oxyhydroxide may interfere with the absorption of certain other medications taken by mouth (including doxycycline). Take these other medications at least 1 hour before taking sucroferric oxyhydroxide. Talk to your pharmacist for more details.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Your doctor may tell you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely.

Do not share this medication with others.

Lab and/or medical tests (such as phosphate/calcium blood levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.