Full Prescribing Information Important Safety Information
CLOSE
SAFETY
MENU

GET CONNECTED

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

Woman holding VEOZAH™ (fezolinetant) logo fire extinguisher

studied for safety and tolerability for 1 year

The safety of VEOZAH was evaluated in three 52-week clinical trials with 1100 women receiving VEOZAH1

Study designs

Trial descriptions

TRIALS 1&2

TWO identical Phase 3 efficacy and safety studies that were randomized, placebo-controlled, double-blind for 12 weeks, followed by rerandomization of women previously receiving placebo to VEOZAH (women on VEOZAH remained on VEOZAH) for an additional 40 weeks of uncontrolled treatment.1

TRIAL 3

ONE Phase 3, 52-week, randomized, placebo-controlled, double-blind study evaluating safety.1

REFERENCE: 1. VEOZAH [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

ADVERSE EVENTS IN TRIAL 3

(≥2% in VEOZAH 45 mg and > placebo)1*
ADVERSE REACTION VEOZAH 45 mg (n=609)   Total person-years=504.2 n (%, EAIR) PLACEBO (n=610)
Total person-years=475.0 n (%, EAIR)
Abdominal pain†26 (4.3%, 5.2)13 (2.1%, 2.7)
Diarrhea24 (3.9%, 4.8)16 (2.6%, 3.4)
Insomnia24 (3.9%, 4.8)11 (1.8%, 2.3)
Back pain18 (3.0%, 3.6) 13 (2.1%, 2.7)
Hot flush15 (2.5%, 3.0)10 (1.6%, 2.1)
Hepatic transaminase elevation‡14 (2.3%, 2.8) 5 (0.8%, 1.1)

In the pooled laboratory data of Trials 1, 2, and 3, elevated hepatic transaminases (>3x the ULN) occurred in 25 women (2.3%, 2.7 EAIR) exposed to VEOZAH 45 mg (n=1100, 912.1 total person-years) as compared to 8 women (0.9%, 1.5 EAIR) exposed to placebo (n=952, 549.1 total person-years).1

EAIR=exposure-adjusted incidence rate.

* Measured as EAIR, meaning the number of individuals experiencing an adverse event divided by exposure time (total person-years) x 100.1

† Abdominal pain (including abdominal pain, abdominal pain lower, abdominal pain upper).1

‡ Hepatic transaminase elevations (including alanine aminotransferase [ALT] abnormal, ALT increased, aspartate aminotransferase [AST] abnormal, AST increased).1

Liver icon

Clinical trials

  • In 3 clinical trials, elevations in serum ALT and/or AST >3x the ULN occurred in 2.3% of patients receiving VEOZAH (EAIR of 2.7 per 100 person-years) and 0.9% (EAIR of 1.5 per 100 person-years) of patients receiving placebo. No elevations in serum total bilirubin (>2x the 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

Postmarketing experience

  • Cases of serious drug-induced hepatotoxicity occurred within 40 days of starting VEOZAH
    • Patients experienced elevated transaminases (up to 50x the ULN at peak elevation), elevated ALP (up to 4x the ULN at peak elevation), and bilirubin (up to 5x the ULN at peak elevation) coupled with symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine
    • After discontinuation of VEOZAH, these abnormalities gradually resolved

Hepatic laboratory testing and discontinuation criteria

  • 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 ALT or AST is ≥2x the ULN or if the total bilirubin is ≥2x the ULN for the evaluating laboratory
  • 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, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain)
  • Discontinue VEOZAH if transaminase elevations are >5x the ULN, or if transaminase elevations are >3x the ULN and the total bilirubin level is >2x the ULN
  • If transaminase elevations >3x the ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution
  • Exclude alternative causes of hepatic laboratory test elevations

ALP=alkaline phosphatase, ULN=upper limit of normal.

Endometrial safety icon

In patients receiving VEOZAH 45 mg across the Phase 3 studies,

  • Endometrial biopsy assessments identified 1 case of endometrial hyperplasia and 1 case of endometrial malignancy
  • The rate of these events was ≤1%, with the upper bound of the one-sided 95% confidence limit being ≤4%
  • Disordered proliferative endometrium was reported in 5 patients receiving VEOZAH 45 mg (EAIR of 1.4 per 100 person-years) and 4 patients receiving placebo (EAIR of 2.0 per 100 person-years)

 

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

EXPAND COLLAPSE

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

WARNING: RISKS OF HEPATOTOXICITY

Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.

  • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
  • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
  • 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, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
  • Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if 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.

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

WARNING: RISKS OF HEPATOTOXICITY

Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.

  • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
  • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
  • 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, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
  • Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if 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.
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.

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

WARNINGS AND PRECAUTIONS

Hepatotoxicity

In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x 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, cases of drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin occurred within 40 days of starting VEOZAH. Patients reported a general sense of feeling unwell and symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine. The patients’ signs and symptoms gradually resolved after discontinuation of VEOZAH.

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 ALT or AST is ≥ 2x ULN or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.

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

See BOXED WARNING for full hepatic laboratory testing protocol and discontinuation criteria. 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, including BOXED WARNING, 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.