FOSRENOL

Absorption and Distribution - Following single- or multiple-dose oral administration of FOSRENOL to healthy subjects, the concentration of lanthanum in plasma was very low (bioavailability <0.002%). Following oral administration in patients, the mean lanthanum C max was 1.0 ng/mL. During long-term administration (52 weeks) in patients with ESRD, the mean lanthanum concentration in plasma was approximately 0.6 ng/mL. There was a minimal increase in plasma lanthanum concentrations with increasing ...

The effectiveness of FOSRENOL in reducing serum phosphorus in patients with ESRD was demonstrated in one short-term, placebo-controlled, double-blind dose-ranging study; two placebo-controlled, randomized withdrawal studies; and two long-term, active-controlled, open-label studies in patients undergoing either hemodialysis or peritoneal dialysis. 14.1 Double-Blind Placebo-Controlled Studies One-hundred and forty-four patients with chronic renal failure undergoing hemodialysis and with elevated phosphate levels were randomized to double-blind treatment at a fixed dose of lanthanum carbonate of ...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal Adverse Effects [see Warnings and Precautions (5.1) ] In controlled trials, the most common adverse reactions that were more frequent (≥5% difference vs. placebo) in FOSRENOL were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of FOSRENOL: constipation, dyspepsia, allergic skin reactions, and tooth injury ...

Contraindicated in patients with: - hypersensitivity to FOSRENOL or to any ingredient in the formulation. - bowel obstruction, including ileus and fecal impaction. Hypersensitivity to FOSRENOL or to any ingredient in the formulation. ( 4 ) Bowel obstruction, ileus, and fecal impaction. ( 4 )

Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction. Risks include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications. Advise patients to chew or crush the tablet completely. ( 5.1 ) FOSRENOL has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.2 ) 5.1 Gastrointestinal Adverse Effects Serious cases of gastrointestinal o...

7 DRUG INTERACTIONS There is a potential for FOSRENOL to interact with compounds that bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based); therefore, do not take such compounds within 2 hours of dosing with FOSRENOL. ( 7.1 ) Oral quinolone antibiotics must be taken at least 1 hour before or 4 hours after FOSRENOL. ( 7.2 ) Do not take thyroid hormone replacement therapy within...