카르복시말토오스수산화제이철착염

Ferric carboxymaltose injection is indicated for the treatment of: • Iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • Iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Ferric carboxymaltose injection is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. ( 1 ) adult patients who have non-dialysis dependent chronic kidney disease. ( 1 ) • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. ( 1 )

Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose injection or any of its components [see Warnings and Precautions ( 5.2) ]. Hypersensitivity to ferric carboxymaltose injection or any of its inactive components.

Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose injection administration for at least 30 minutes and until clinically stable following completion of each administration. ( 5. 2) Hypertension: Monitor patients closely for signs and symptoms of hypertension following each ferric carboxymaltose injection administration. ( 5.3 ) 5.1 Symptomatic Hypophosphatemia Symptomatic hypophosphatemia, including severe cases, with serious outcomes such as osteomalacia and fractures requiring clinical intervention have occurred in patients treated with ferric carboxymaltose injection in the post-marketing setting. These cases have occurred after single and multiple doses of ferric carboxymaltose injection. Risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). However, individuals without apparent risk factors have experienced symptomatic hypophosphatemia. In most cases, hypophosphatemia resolved within three months. Check serum phosphate levels prior to a repeat course of treatment if the patient is at risk for low serum phosphate or if the patient will receive a repeat course of …

8.1 Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [ see Warnings and Precautions ( 5.2 )], which may have serious consequences, such as fetal bradycardia ( see Clinical Considerations ). Advise pregnant women of the potential risk to a fetus. Published studies and available data from postmarketing reports with intravenous ferric carboxymaltose injection are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations). In …