Clinical use:

• Pediatrics (<18 years of age): not indicated.
• Geriatrics (≥65 years of age): no data available; therefore, an indication has not been recommended.

Contraindications:

• Known cirrhosis
• Severe renal impairment or end-stage renal disease
• Patients using concomitant moderate or strong CYP1A2 inhibitors
• Known or suspected pregnancy

Relevant warnings and precautions:

• Benefit-risk consideration to treat women with known or previous breast cancer or other estrogen-dependent malignancies
• Not recommended in Child-Pugh Class B (moderate) chronic hepatic impairment; not studied in Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population
• Risk of hepatic transaminase elevation and hepatotoxicity
• Perform baseline bloodwork to evaluate hepatic function and assess for injury (including serum ALT, serum AST, serum ALP, and serum bilirubin [total and direct]) prior to initiating VEOZAH. Perform hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy
• Incidence of other malignancies; a causal relationship between VEOZAH and increased risk of malignancies has not been established
• Risk of endometrial hyperplasia and endometrial carcinoma. In the VEOZAH 45 mg dose group across the three phase 3 studies, endometrial biopsy assessments identified one case of endometrial hyperplasia and one case of endometrial malignancy (0.6% with a one-sided upper limit of 95% confidence of 1.8%). The rate of these events in the VEOZAH 45 mg dose group was ≤1% with the upper bound of the one-sided 95% confidence limit being ≤4%. There was no case of endometrial hyperplasia or carcinoma in the placebo group
• Not recommended in breast-feeding women

For more information:

Consult the Product Monograph at www.veozahmonograph.ca for important information relating to adverse reactions, drug interactions and dosing information. The Product Monograph is also available by calling 1-888-338-1824.