Akebia Therapeutics Announces Collaboration Partner's Submission of Supplemental New Drug Application for Use of Riona® (ferric citrate hydrate) to Treat Adult Patients with Iron Deficiency Anemia in Japan
The NDA is based on JT and Torii's Phase 3 clinical study and other clinical studies in adult patients with IDA in
Riona was approved in
"IDA can have a significant impact on the health and quality of life of people living with kidney disease. As an oral drug, Auryxia enables CKD patients not on dialysis, a high-risk population, to be treated for IDA while remaining safely at home," said
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About Auryxia® (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the FDA on
AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
Most common adverse reactions with AURYXIA were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%).
- Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%).
- Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact
Please see full Prescribing Information
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