AURYXIA Film-coated tablet (2019)

Βιβλιογραφική αναφορά

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Keryx Biopharmaceuticals, Inc.

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1. Indications and Usage

Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Iron Deficiency Anemia ...

2. Dosage and Administration

2.1 Dosage for Hyperphosphatemia in Chronic Kidney Disease on Dialysis The recommended starting dose is 2 tablets orally 3 times per day with meals. Monitor serum phosphorus levels and titrate the Auryxia ...

3. Dosage Forms and Strengths

Tablets: Auryxia 210 mg ferric iron, equivalent to 1 g ferric citrate, film-coated, peach-colored, and oval-shaped tablet debossed with KX52.

4. Contraindications

Auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see Warnings and Precautions (5.1)].

5. Warnings and Precautions

5.1 Iron Overload Iron absorption from Auryxia may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to adverse reaction rates in the clinical ...

7. Drug Interactions

Table 2. Oral drugs that can be administered concomitantly with Auryxia: Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol ...

8.1. Pregnancy

Risk Summary There are no available data on Auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using ...

8.2. Lactation

Risk Summary There are no human data regarding the effect of Auryxia in human milk, the effects on the breastfed child, or the effects on milk production. Data from rat studies have shown the transfer ...

8.4. Pediatric Use

The safety and efficacy of Auryxia have not been established in pediatric patients.

8.5. Geriatric Use

Clinical studies of Auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses ...

10. Overdosage

No data are available regarding overdose of Auryxia in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg ferric iron (12 tablets of Auryxia) per day. Iron absorption ...

11. Description

Auryxia (ferric citrate), a phosphate binder and iron replacement product, is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2 hydroxy-), y (H2O) Auryxia ...

12.1. Mechanism of Action

Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. ...

12.2. Pharmacodynamics

Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia reduces serum phosphorus levels and has also been shown to increase serum iron parameters, including ferritin, iron and TSAT. In dialysis ...

12.3. Pharmacokinetics

Absorption and Distribution Formal pharmacokinetic studies have not been performed with Auryxia. Examination of serum iron parameters has shown that there is systemic absorption of iron from Auryxia ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Data from carcinogenesis studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously. Ferric citrate was neither mutagenic in the bacterial ...

14. Clinical Studies

14.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis The ability of Auryxia to lower serum phosphorus in patients with CKD on dialysis was demonstrated in randomized clinical trials: one 56-week, ...

16.1. 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, ...

16.2. Storage and Handling

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.

17. Patient Counseling Information

Dosing Recommendations Instruct 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 ...