VEOZAH Dosing

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Recommended dosing and administration¹

45 mg orally once daily, with or without food

Take VEOZAH with liquids at about the same time every day, and swallow whole. Do not cut, crush, or chew tablets.

Missed dose guidance

If a dose is missed or not taken at the usual time, patients should take the missed dose as soon as possible, unless there are fewer than 12 hours before the next scheduled dose. Return to the regular schedule the following day.

Special populations

Hepatic Impairment

VEOZAH is contraindicated in individuals with cirrhosis.
VEOZAH is not recommended for use in individuals with Child-Pugh Class B (moderate) chronic hepatic impairment.
VEOZAH has not been studied in individuals with Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population.
No dose modification is recommended for individuals with Child-Pugh Class A (mild) chronic hepatic impairment.

Renal Impairment

VEOZAH is contraindicated in individuals with severe* renal impairment.
VEOZAH has not been studied in individuals with end-stage renal disease^† and is contraindicated in this population.
No dose modification is recommended for individuals with mild^‡ or moderate^§ renal impairment.

* eGFR less than 30 mL/min/1.73 m²
† eGFR less than 15 mL/min/1.73 m²
‡ eGFR 60 to less than 90 mL/min/1.73 m²
§ eGFR 30 to less than 60 mL/min/1.73 m²

Dosing considerations¹

Perform baseline bloodwork to evaluate hepatic function and assess for injury including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct) before initiating treatment with VEOZAH.
Do not start VEOZAH if ALT or AST is equal to or exceeds
2 times the upper limit of normal (ULN) or if the total bilirubin is elevated (is equal to or exceeds 2 x ULN). Proceed with caution if ALT or AST is between >1.5 x ULN and <2 x ULN.
While using VEOZAH, perform follow-up evaluations of hepatic transaminase concentration monthly during the first 3 months, at 6 months, and 9 months after initiation of therapy.
Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury.
- Signs or symptoms that may suggest liver injury include new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.
Discontinue VEOZAH if transaminase elevations are ≥5 x ULN and/or transaminase elevations are ≥3 x ULN and the total bilirubin level is ≥2 x ULN.
- If transaminase elevations ≥3 x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.
- Exclude alternative causes of hepatic laboratory test elevations.

Consider once-daily VEOZAH for your patients

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Important Safety Information

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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

Read less

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:

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ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase.

*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.

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