Auryxia

Name: Auryxia

What Is Auryxia?

Ferric citrate is a phosphate binder that helps prevent hypocalcemia (low levels of calcium in the blood) caused by elevated phosphorus.

Ferric citrate is used to control phosphorus levels in people with chronic kidney disease who are on dialysis.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use ferric citrate if you are allergic to it.

To make sure ferric citrate is safe for you, tell your doctor if you have:

  • iron overload disorder (hemochromatosis);
  • liver disease;
  • a stomach or intestinal disorder;
  • if you have recently had stomach or intestinal surgery; or
  • if you take thyroid replacement medicine (levothyroxine, Synthroid, and others).

Ferric citrate is not expected to harm an unborn or nursing baby. Tell your doctor if you are pregnant or breast-feeding.

This medicine is not approved for use by anyone younger than 18 years old.

Warnings

Contraindications

Iron overload syndromes (eg, hemochromatosis)

Cautions

Iron absorption from ferric citrate may lead to excessive elevations in iron stores

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 yr; keep out of the reach of children

Patients with inflammatory bowel disease or active, symptomatic GI bleeding were excluded from clinical trials; safety has not been established in these populations

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of iron can be fatal to a child who accidentally consumes this medicine.

Auryxia Pharmacokinetics

Absorption

Formal pharmacokinetic studies not performed.1 Changes in serum iron indices indicate iron from ferric citrate is systemically absorbed.1

Advice to Patients

  • Importance of adhering to instructions about diet.1

  • Importance of taking ferric citrate as directed with meals.1

  • Importance of instructing patients about any concomitantly used drugs that should be taken at a different time of day than when ferric citrate is taken.1

  • Potential for ferric citrate to cause discolored (dark) stools.1

  • Potential for ferric citrate to cause diarrhea, nausea, constipation, and vomiting.1 Importance of reporting severe or persistent GI symptoms to clinician.1

  • Risk of fatal iron poisoning in children <6 years of age.1 Importance of keeping ferric citrate out of reach of children.1 Contact a clinician or poison control center immediately in case of accidental overdosage.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Before Using Auryxia

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 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 citrate in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 taking this medicine, 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 this medicine 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 this medicine 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.

  • Carbidopa
  • Cefdinir
  • Delafloxacin
  • Demeclocycline
  • Dolutegravir
  • Doxycycline
  • Gatifloxacin
  • Grepafloxacin
  • Levodopa
  • Levofloxacin
  • Levothyroxine
  • Lomefloxacin
  • Methyldopa
  • Minocycline
  • Moxifloxacin
  • Mycophenolic Acid
  • Norfloxacin
  • Ofloxacin
  • Omeprazole
  • Penicillamine
  • Temafloxacin
  • Tetracycline
  • Trovafloxacin Mesylate
  • 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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Dairy Food
  • Phytic Acid Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hemochromatosis (a genetic disorder which causes too much iron in the blood)—Should not be used in patients with this condition.
  • Inflammatory bowel disease or
  • Stomach or bowel problem (eg, bleeding)—This medicine has not been studied in patients with these conditions, but should be monitored for more serious side effects.

Proper Use of Auryxia

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Take this medicine with meals.

If you are taking doxycycline, take it at least 1 hour before you take ferric citrate.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For control of phosphorus levels in patients with chronic kidney disease on dialysis:
      • Adults—At first, 2 tablets three times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very upset stomach or throwing up.
  • Very loose stools (diarrhea).
  • Very hard stools (constipation).

How Supplied/Storage and Handling

How Supplied

Tablets: Auryxia 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. The 210 mg ferric iron tablets are film-coated, peach-colored, and oval-shaped tablets debossed with “KX52.”

1 Bottle of 200-count 210 mg ferric iron tablets (NDC 59922-631-01)

Storage and Handling

Storage: Store at 20 to 25°C (68 to 77°F): excursions permitted to 15° to 30°C (59°F to 86°F) [See USP controlled room temperature]. Protect from moisture.

Patient Counseling Information

Dosing Recommendations

Inform patients to take Auryxia as directed with meals and adhere to their prescribed diets. Instruct patients on concomitant medications that should be dosed apart from Auryxia.

Adverse Reactions

Advise patients that Auryxia may cause discolored (dark) stools, but this staining of the stool is considered normal with oral medications containing iron.

Auryxia may cause diarrhea, nausea, constipation and vomiting. Advise patients to report severe or persistent gastrointestinal symptoms to their physician.


Manufactured for and Distributed by:

Keryx Biopharmaceuticals, Inc.
One Marina Park Drive, 12th Floor Boston, MA 02210, USA


Issued 11/2016 Rev 3.3

PRINCIPAL DISPLAY PANEL - NDC: 59922-631-01 - 210 mg 200-ct Bottle

PRINCIPAL DISPLAY PANEL - NDC: 59922-631-91 - 210 mg 200-ct Professional Samples Bottle

PRINCIPAL DISPLAY PANEL - NDC: 59922-631-92 - 210 mg 50-ct Professional Samples Bottle

Auryxia 
ferric citrate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59922-631
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRAFERRIC TRICITRATE DECAHYDRATE (FERRIC CATION) FERRIC CATION 210 mg
Product Characteristics
Color PINK Score no score
Shape OVAL Size 19mm
Flavor Imprint Code KX52
Contains     
Packaging
# Item Code Package Description
1 NDC:59922-631-01 200 TABLET, COATED in 1 BOTTLE
2 NDC:59922-631-91 200 TABLET, COATED in 1 BOTTLE
3 NDC:59922-631-92 50 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205874 09/17/2014
Labeler - Keryx Biopharmaceuticals, Inc. (073504263)
Revised: 11/2016   Keryx Biopharmaceuticals, Inc.
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