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Divide the total daily dose of LANTHANUM CARBONATE and take with or immediately after meals. The recommended initial total daily dose of LANTHANUM CARBONATE is 1,500 mg. Titrate the dose every 2 to 3 weeks until an acceptable serum phosphate level is reached. Monitor serum phosphate levels as needed during dose titration and on a regular basis thereafter. LANTHANUM CARBONATE has the potential to bind other orally administered drugs; consider separating the administration of other oral medications [see Drug Interactions (7) ] . In clinical studies of patients with ESRD, LANTHANUM CARBONATE doses up to 4,500 mg were evaluated. Most patients required a total daily dose between 1,500 mg and 3,000 mg to reduce plasma phosphate levels to less than 6.0 mg/dL. Doses were generally titrated in increments of 750 mg/day. Chew or crush LANTHANUM CARBONATE completely before swallowing. Do not swallow intact LANTHANUM CARBONATE Chewable Tablets. Consider using the oral powder formulation in patients with poor dentition or who have difficulty chewing tablets. The recommended initial total daily dose of LANTHANUM CARBONATE is 1,500 mg in divided doses. Titrate every 2 to 3 weeks based on serum phosphate level. ( 2 ) Take LANTHANUM CARBONATE with or immediately after meals. ( 2 ) Chew or crush tablet completely before swallowing. ( 2 )

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 LANTHANUM CARBONATE were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of LANTHANUM CARBONATE: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall, the safety profile of LANTHANUM CARBONATE has been studied in over 5,200 subjects in completed clinical trials. The most common adverse reactions for LANTHANUM CARBONATE were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing. In double-blind, placebo-controlled studies where a total of 180 and 95 patients with ESRD were…

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

The symptoms associated with overdose are adverse reactions such as headache, nausea and vomiting. In clinical trials in healthy adults, gastrointestinal (GI) symptoms were reported with daily doses up to 6,000 mg/day of lanthanum carbonate administered with food. Given the topical activity of lanthanum in the gut, and the excretion of the majority of the dose in feces, supportive therapy is recommended for overdosage. Lanthanum carbonate was not acutely toxic in animals by the oral route. No deaths and no adverse effects occurred in mice, rats, or dogs after single oral doses of 2,000 mg/kg (1.7, 3.4, and 11.3 times the MRHD, respectively, on a mg/m 2 basis).

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

There is a potential for LANTHANUM CARBONATE 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 LANTHANUM CARBONATE. ( 7.1 ) Oral quinolone antibiotics must be taken at least 1 hour before or 4 hours after LANTHANUM CARBONATE. ( 7.2 ) Do not take thyroid hormone replacement therapy within 2 hours of dosing with LANTHANUM CARBONATE. Monitoring of TSH levels is recommended in patients receiving both medicinal agents. ( 7.3 ) For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. ( 7.4 ) 7.1 Drugs Binding to Antacids There is a potential for LANTHANUM CARBONATE to interact with compounds which bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based); therefore, do not administer such compounds within 2 hours of dosing with LANTHANUM CARBONATE. Examples of relevant classes of compounds where antacids have been demonstrated to reduce bioavailability include antibiotics (such as quinolones, ampicillin, and tetracyclines), thyroid hormones, ACE inhibitors, statin lipid regulators, and anti-malarials. 7.2 Quinolone Antibiotics Co-administration of LANTHANUM CARBONATE with quinolone antibiotics may reduce the extent of their absorption. The bioavailability of oral ciprofloxacin was decreased by approximately 50% when taken with LANTHANUM CARBONATE in a single-dose study in healthy volunteers. Administer oral quinolone antibiotics at least 1 hour before or 4 hours after LANTHANUM CARBONATE. When oral quinolones are given for short courses, consider eliminating the doses of LANTHANUM CARBONATE that would normally be scheduled near the time of quinolone intake to improve quinolone absorption [see Clinical Pharmacology (12.3) ] . 7.3 Levothyroxine The bioavailability of levothyroxine was decreased by approximately 40% when taken together with LANTHANUM CARBONATE. Administer thyroid hormone replacement therapy at least 2 hours before or 2 hours after dosing with LANTHANUM CARBONATE and monitor thyroid stimulating hormone (TSH) levels [see Clinical Pharmacology (12.3) ] . 7.4 Use with Other Oral Medications There are no empirical data on avoiding drug interactions between LANTHANUM CARBONATE and most concomitant oral drugs. For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate-release or an extended-release product. Consider monitoring clinical responses or blood levels of concomitant medications that have a narrow therapeutic range.