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 therapy within three months of the prior course [see Dosage and Administration (2.1, 2.3)]. Correct pre-existing hypophosphatemia prior to administering ferric carboxymaltose injection. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Treat hypophosphatemia as medically indicated.

Consider permanent discontinuation of ferric carboxymaltose injection for severe symptomatic hypophosphatemia or persistent hypophosphatemia.