Select Language

Stay Up to Date

By signing up below to receive more information, you will receive exclusive email updates about VEOZAH and related materials, and you may be contacted by an Astellas representative.

 

Mandatory fields are denoted by an asterisk (*)
  • You must affirm that you’d like to stay up to date.
Clinic Address:  
 
Terms and Conditions

I have read and agree to the Terms of Use  and Privacy Policy*

I have a medical inquiry.

Thank you

Your request has been submitted. 

Important Safety Information

Indication body title

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.

Important Safety Information

Indication body title

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.

*Comparative clinical significance unknown.

†SKYLIGHT 2 was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, study in which post-menopausal women were randomized to VEOZAH 45 mg (n=167) or placebo (n=167) once daily for 12 weeks. After the 12-week, double-blind treatment period, all patients received VEOZAH for a 40-week extension treatment period with women on placebo re-randomized to VEOZAH to evaluate safety for up to 52 weeks total exposure. The study included post-menopausal women who had a minimum average of 7 moderate to severe VMS per day. The coprimary efficacy endpoints were change from baseline in moderate to severe VMS frequency and severity to weeks 4 and 12. Baseline mean frequency of moderate to severe VMS per 24 hours: 11.8 for VEOZAH, 11.6 for placebo.1

‡Clinical significance is unknown.