VELTASSA

1 Dosing Considerations • The onset of action of VELTASSA occurs 4 to 7 hours after administration. VELTASSA should not replace emergency treatment for life threatening hyperkalemia due to its delayed onset of action. • In general, administration of VELTASSA should be separated by 3 hours from other oral medicinal products.

4 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment), or after changes are made to medicinal products that affect serum potassium levels (see 7 WARNINGS AND PRECAUTIONS). • There are limited data on the use of VELTASSA in patients on dialysis.

No special dose and administration guidelines were applied to these patients in clinical studies. 4 g patiromer once daily. The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range.

2 g once VELTASSA® Patiromer Powder for Oral Suspension Page 5 of 28 daily. Multiple sachets may be used to achieve the desired dose. If serum potassium falls below the desired range, the dose should be reduced or discontinued.

Pediatrics (<18 years of age):

Health Canada has not authorized an indication for pediatric use. 3 Pediatrics.

Geriatrics (≥65 years of age):

Geriatric patients should follow the dosage adjustment scheme provided in 0. No additional dosage adjustment considerations are required for geriatric patients. 4 Geriatrics. 3 Reconstitution VELTASSA should be mixed with water, and stirred to a suspension of uniform consistency, according to the following steps: • The complete dose should be poured into a glass containing approximately 40 mL of water, then stirred.

• Another approximately 40 mL of water should be added, and the suspension stirred again thoroughly. The powder will not dissolve. • More water may be added to the mixture as needed for desired consistency. • The mixture should be taken within 1 hour of initial suspension.

• If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately. This may be repeated as needed to ensure the entire dose is administered. , cornstarch) in liquid or soft food, apple sauce, vanilla and chocolate pudding.

1 Adverse Reaction Overview The majority of the adverse reactions (ARs) reported from trials (based on a pooled safety population of 666 patients) were gastrointestinal disorders and hypomagnesemia. Gastrointestinal disorder reactions were generally mild to moderate in nature, generally resolved spontaneously or with treatment, and none were reported as serious.

4 mmol/L. 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 the safety and efficacy clinical trials, 666 adult patients received at least one dose of VELTASSA, including 219 exposed for at least 6 months and 149 exposed for at least one year.

Table 2 provides a summary of the most common adverse reactions (occurring in ≥ 1% of patients) assessed by investigators as related to VELTASSA in these clinical trials. Most adverse reactions were mild to moderate, and occurred within the first 4 weeks of treatment.

5% In the placebo-controlled study RLY5016-202, the ability of VELTASSA to enable concomitant spironolactone treatment was investigated in a randomized, double-blind, placebo-controlled study in heart failure patients. 1 mmol/L. VELTASSA dose was not titrated in this study.

Table 3 provides a summary of the most common adverse events (occurring in ≥ 1% of patients) described by investigator as related to study treatment (VELTASSA or placebo) in patients in this clinical trial. 0 mmol/L 0% For more information on hypokalemia or hypomagnesemia, refer to WARNINGS AND PRECAUTIONS.

). • There are limited data on the use of VELTASSA in patients on dialysis. No special dose and administration guidelines were applied to these patients in clinical studies. 4 g patiromer once daily. The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range.

2 g once VELTASSA® Patiromer Powder for Oral Suspension Page 5 of 28 daily. Multiple sachets may be used to achieve the desired dose. If serum potassium falls below the desired range, the dose should be reduced or discontinued.

Pediatrics (<18 years of age):

Health Canada has not authorized an indication for pediatric use. 3 Pediatrics.

Geriatrics (≥65 years of age):

Geriatric patients should follow the dosage adjustment scheme provided in 0. No additional dosage adjustment considerations are required for geriatric patients. 4 Geriatrics. 3 Reconstitution VELTASSA should be mixed with water, and stirred to a suspension of uniform consistency, according to the following steps: • The complete dose should be poured into a glass containing approximately 40 mL of water, then stirred.

• Another approximately 40 mL of water should be added, and the suspension stirred again thoroughly. The powder will not dissolve. • More water may be added to the mixture as needed for desired consistency. • The mixture should be taken within 1 hour of initial suspension.

• If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately. This may be repeated as needed to ensure the entire dose is administered. , cornstarch) in liquid or soft food, apple sauce, vanilla and chocolate pudding.

The potassium content of liquids or soft foods as those shown above that are used to prepare the mixture should be considered as part of the dietary recommendations on potassium intake for each individual patient. 4 Administration Oral use.

VELTASSA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 0 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

Patients with the rare hereditary condition of fructose intolerance • Sorbitol:

VELTASSA contains approximately 11 g of sorbitol per maximum recommended daily dose.