NAT-LANTHANUM

1 Dosing Considerations Serum phosphorus levels should be monitored as needed during titration until an optimal serum phosphorus level is reached, and then on a regular basis thereafter. 2 Recommended Dose and Dosage Adjustment The recommended initial daily dose of NAT-LANTHANUM (lanthanum carbonate dihydrate) for adults is 750 mg-1500 mg.

The dose should be titrated every 2-3 weeks to a level that achieves maintenance of acceptable serum phosphorus levels. The daily dose should be divided and taken with or immediately after meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake.

NAT-LANTHANUM is presented as a chewable tablet, therefore avoiding the need to take additional fluid. NAT-LANTHANUM Product Monograph Page 5 of 33 In clinical studies in ESRD patients, lanthanum carbonate doses up to 4500 mg were evaluated.

92 mmol/L). Doses were generally titrated in increments of 750 mg/day. Health Canada has not authorized an indication for pediatric use. 4 Administration Tablets should be chewed completely before swallowing. The tablets may be crushed as an aid to chewing.

Intact tablets should not be swallowed. Consider crushing tablets completely for patients with poor dentition. 5 Missed Dose A missed dose should be taken at the next scheduled dose with a meal. Taking a dose at a time other than mealtime may lead to nausea and vomiting.

Patients should not double-up the dose to catch up.

1 Adverse Reaction Overview Gastrointestinal symptoms including, but not limited to, nausea, vomiting, abdominal cramps and diarrhea were observed in patients taking lanthanum carbonate. These symptoms were less frequent when taking NAT-LANTHANUM with or immediately after food.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In three placebo-controlled studies in end stage renal disease (ESRD) patients, the most common adverse events for lanthanum carbonate were gastrointestinal events such as nausea and vomiting, and they generally abated over time with continued dosing.

Adverse events that were more frequent (≥5% difference) in the lanthanum carbonate group are presented in Table 2. 0 WHOART = World Health Organization Adverse Reactions Thesaurus, NW = non-WHOART term developed by Sponsor for the clinical development program NAT-LANTHANUM Product Monograph Page 9 of 33 The safety of lanthanum carbonate was studied in two long-term clinical trials that included 1215 patients treated with lanthanum carbonate and 944 with alternative therapy.

Sixteen percent (16%) of patients in these comparative, open-label studies discontinued in the lanthanum carbonate-treated group due to adverse events. Gastrointestinal adverse events, such as nausea, diarrhea and vomiting, were the most common type of event leading to discontinuation.

The number of withdrawals and the most common adverse events (≥5% in either treatment group) in both the long-term (2 year), open-label, active-controlled, study of lanthanum carbonate vs. alternative therapy (Study A) and the 6-month, comparative study of lanthanum carbonate vs.

, Gastrointestinal 08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…………………………………………………………………………………………. 2 TABLE OF CONTENTS ..............................................................................................................

2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................

4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................

5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 8 8 ADVERSE REACTIONS ..................................................................................................

11 NAT-LANTHANUM Product Monograph Page 3 of 33 9 DRUG INTERACTIONS ................................................................................................ 14 10 CLINICAL PHARMACOLOGY .......................................................................................

15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 17 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 17 PART II: SCIENTIFIC INFORMATION .......................................................................................

NAT-LANTHANUM (lanthanum carbonate dihydrate) is contraindicated in: • Patients with bowel obstruction, ileus and fecal impaction • Patients with hypophosphatemia • Patients with hypersensitivity to lanthanum carbonate or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.