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Mechanism of action (MOA) flashcard

Mechanism of action (MOA) flashcard

Quickly reference the mechanism of action of VEOZAH.

MOA video

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Watch the mechanism of action of VEOZAH.

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Menopause Foundation of Canada

The Menopause Foundation of Canada (MFC) was created to raise awareness of the impact of menopause on your patients and society.

Frequently asked questions

VEOZAH is used for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes and night sweats.1,2

VEOZAH is a selective neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the hypothalamus.1

VEOZAH’s efficacy profile assessed the change from baseline to Weeks 4 and 12 in the frequency and severity of moderate to severe VMS compared to placebo.1

 

The efficacy of VEOZAH was evaluated in the first 12-week, randomized, placebo-controlled, double-blind portion of two identical Phase 3 studies. In each of these two trials, after the first 12 weeks, women on placebo were then re-randomized to VEOZAH for a 40-week extension to evaluate safety for up to 52 weeks total exposure.1

VEOZAH should be administered orally once daily at about the same time each day, with or without food, and taken with liquids.
VEOZAH should be swallowed whole. Do not cut, crush, or chew tablets.1

The most common adverse drug reaction during the 12-week placebo-controlled period in SKYLIGHT 1 and SKYLIGHT 2 (≥3% in patients receiving VEOZAH 45 mg and greater than placebo) was liver test elevation (3.2%).1

 

During the 52-week placebo-controlled period in SKYLIGHT 4, the most frequent adverse drug reactions (≥3% in patients receiving VEOZAH 45 mg and greater than placebo) were headache (9.7%), liver test elevation (5.3%), abdominal pain (4.4%), diarrhea (3.9%), insomnia (3.9%), and nausea (3.1%).1

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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.

REFERENCES: 1. VEOZAH Product Monograph. Markham, ON: Astellas Pharma Canada, Inc. 2. 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.