Select Language
Woman on the beach with wind in her face. Refine how you treat menopausal VMS
Woman on the beach with wind in her face. Refine how you treat menopausal VMS
A woman and a man walks hand in hand near by the beach

EFFICACY AND SAFETY PROFILES

Explore the efficacy and safety profiles of VEOZAH from the SKYLIGHT pivotal trials1

The 2023 nonhormone therapy position statement of the North American Menopause Society recommends fezolinetant as an option for non-hormonal therapy for vasomotor symptoms in women who are not candidates for hormone therapy because of contraindications or personal preference.2

 

Refer to the full 2023 nonhormone therapy position statement of The North American Menopause Society for further information.

Get to know VEOZAH

 

VEOZAH is a selective neurokinin 3 (NK3) receptor antagonist.1‡
A woman and a man walks hand in hand near by the beach

MOA

Watch the mechanism of action (MOA)

VEOZAH selectively binds to the neurokinin 3 (NK3) receptor to block NKB from binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron.1-3‡

Sign up for exclusive VEOZAH updates and product information

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.

Qualifiers
ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; LS: least squares.

 

*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.

REFERENCES: 1. VEOZAH Product Monograph. Markham, ON: Astellas Pharma Canada, Inc. 2. The North American Menopause Society (NAMS). Menopause. 2023;30(6):573-590. 3. Data on File. 4. Yuksel N, Evaniuk D, Huang L, et al. Guideline No. 422a: Menopause: vasomotor symptoms, prescription therapeutic agents, complementary and alternative medicine, nutrition, and lifestyle. J Obstet Gynaecol Can. 2021 Oct;43(10):1188-1204.e1.