FOSRENOL® (lanthanum carbonate)

Indication

FOSRENOL is indicated to reduce serum phosphate in patients with end stage renal disease.

Important Safety Information

• FOSRENOL is contraindicated in patients with bowel obstruction, ileus, and fecal impaction.
• Serious cases of gastrointestinal obstruction, ileus, and fecal impaction have been associated with lanthanum use, some requiring surgery or hospitalization. Risk factors include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications.
• Advise patients to chew or crush the tablet completely to reduce the risk of adverse gastrointestinal events. Advise patients with poor dentition that they may crush tablets completely. Advise patients to take FOSRENOL with or immediately after meals.
• Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, or bowel obstruction were not included in FOSRENOL clinical studies.
• FOSRENOL has radio-opaque properties and may give the appearance typical of an imaging agent during abdominal X-ray procedures.
• The most common reactions seen with FOSRENOL in clinical trials included nausea, vomiting, diarrhea, and abdominal pain.
• There is potential for FOSRENOL to interact with (1) compounds that bind to cationic antacids (ie, aluminum-, magnesium-, or calcium-based agents), (2) oral quinolone antibiotics, and (3) thyroid replacement medication; therefore, such concomitant medications should be dosed separately from FOSRENOL to avoid drug interactions. See specific dosing recommendations in the full Prescribing Information.
• No adequate and well-controlled studies have been conducted in pregnant women and pediatric patients. FOSRENOL is not recommended for use during pregnancy.
• The safety of lanthanum carbonate excreted in human milk is unknown. Caution should be exercised when FOSRENOL is administered to a nursing woman.
• The use of FOSRENOL in the pediatric population is not recommended.

Please see Full Prescribing Information.