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For the treatment of moderate to severe Vasomotor Symptoms (VMS)—commonly referred to as hot flashes and night sweats—due to menopause1,2

Woman spraying VEOZAH™ (fezolinetant) logo fire extinguisher at VMS fire in living room with man sitting and watching

TREAT THE HEAT with 1 TABLET A DAY

Dosing and administration

VEOZAH™ (fezolinetant) sample box, sample bottle, and tablet

Tablet is not actual size.

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Take VEOZAH with liquids and swallow whole. Do not cut, crush, or chew tablets.1

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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.1

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Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if the concentration of ALT or AST is ≥2x ULN or if the total bilirubin is elevated (eg, ≥2x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is <2x ULN and the total bilirubin is normal, VEOZAH can be started.1

Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.1

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.1

ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, ULN=upper limit of normal.

VEOZAH™ (fezolinetant) sample box, sample bottle, and tablet

Tablet is not actual size.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. Concomitant use with CYP1A2 inhibitors

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. Concomitant use with CYP1A2 inhibitors
INDICATIONS AND USAGE

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

WARNINGS AND PRECAUTIONS

Hepatic Transaminase Elevation and Hepatotoxicity

In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x the upper limit of normal (ULN) occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo. No elevations in serum total bilirubin (> 2x ULN) occurred. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Women with cirrhosis were not studied.

In the postmarketing setting, a case of acute mixed hepatocellular cholestatic drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin with symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine occurred in a woman receiving VEOZAH. The individual’s signs and symptoms gradually resolved after discontinuation of the drug.

Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if the concentration of ALT or AST is ≥ 2x ULN or if the total bilirubin is elevated (e.g., ≥ 2x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is < 2x ULN and the total bilirubin is normal, VEOZAH can be started.

Perform follow-up hepatic laboratory tests monthly for 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: New onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or upper right quadrant pain.

Discontinue VEOZAH if:

  1. Transaminase elevations are > 5x ULN 
  2. Transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN

If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.

Exclude alternative causes of hepatic laboratory test elevations.

ADVERSE REACTIONS

The most common adverse reactions with VEOZAH ≥ 2% and > placebo (VEOZAH % vs. placebo %) are: abdominal pain (4.3% vs. 2.1%), diarrhea (3.9% vs. 2.6%), insomnia (3.9% vs. 1.8%), back pain (3.0% vs. 2.1%), hot flush (2.5% vs. 1.6%), and hepatic transaminase elevation (2.3% vs. 0.8%).

Please click here for full Prescribing Information for VEOZAH (fezolinetant).

REFERENCES: 1. VEOZAH [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician’s Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55.

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