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VEOZAH (fezolinetant) is a small-molecule NK3 receptor antagonist.
The chemical name of fezolinetant is (4-Fluorophenyl)[(8R)-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]methanone having a molecular formula of C16H15FN6OS and a molecular weight of 358.39. The structural formula of fezolinetant is:
 |
Fezolinetant is a white powder. It is very slightly soluble in water (0.29 mg/mL).
Each VEOZAH (fezolinetant) tablet for oral use contains 45 mg of fezolinetant and the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
VEOZAH® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Take a single 45 mg VEOZAH tablet orally once daily with or without food.
Take VEOZAH with liquids and swallow whole. Do not cut, crush, or chew tablets.
Administer VEOZAH orally at about the same time each day. If a dose of VEOZAH is missed or not taken at the usual time, administer the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose. Return to the regular schedule the following day.
Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with VEOZAH. Do not start VEOZAH if ALT or AST is ≥ 2 x ULN or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory.
While using VEOZAH, 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 [see WARNINGS AND PRECAUTIONS].
Tablets: 45 mg, round, light red, film-coated tablets, debossed with the Astellas logo and ‘645’ on the same side.
VEOZAH (fezolinetant) 45 mg tablets are supplied as round, light red, film-coated tablets, debossed with the Astellas logo and ‘645’ on the same side.VEOZAH tablets are available in the following package sizes:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Distributed by: Astellas Pharma US, Inc. Northbrook, IL 60062. Revised: Dec 2024
The following serious adverse reactions are discussed elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of VEOZAH was evaluated in three 52-week clinical trials [see Clinical Studies]. Across the three clinical trials, a total of 1100 women received VEOZAH. Trials 1 and 2 were placebo-controlled for the first 12 weeks, followed by re-randomization of women previously receiving placebo to VEOZAH (women on VEOZAH remained on VEOZAH) for an additional 40 weeks of uncontrolled treatment. Trial 3 was a randomized, placebo-controlled, double-blind safety study evaluating the safety of VEOZAH for 52 weeks. The adverse reactions reported in at least 2% in VEOZAH 45 mg and greater than placebo in Trial 3 are presented in Table 1.
Table 1: Adverse Reactions Reported in at Least 2% in VEOZAH 45 mg and Greater Than Placebo in a PlaceboControlled, Double-Blind 52-Week Trial (Trial 3)
| Adverse Reaction | VEOZAH 45 mg (n=609) Total Person-Years=504.2 n (%, EAIR1) |
Placebo (n=610) Total Person-Years=475.0 n (%, EAIR1) |
| Abdominal pain2 | 26 (4.3%, 5.2) | 13 (2.1%, 2.7) |
| Diarrhea | 24 (3.9%, 4.8) | 16 (2.6%, 3.4) |
| Insomnia | 24 (3.9%, 4.8) | 11 (1.8%, 2.3) |
| Back pain | 18 (3.0%, 3.6) | 13 (2.1%, 2.7) |
| Hot flush | 15 (2.5%, 3.0) | 10 (1.6%, 2.1) |
| Hepatic transaminase elevation3 | 14 (2.3%, 2.8) | 5 (0.8%, 1.1) |
| 1. EAIR = Number of individuals experiencing an adverse event divided by exposure time (total person-years) x 100. 2. Abdominal pain (including Abdominal pain, Abdominal pain lower, Abdominal pain upper). 3. Hepatic transaminase elevations (including Alanine aminotransferase abnormal, Alanine aminotransferase increased, Aspartate aminotransferase abnormal, Aspartate aminotransferase increased). |
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In the pooled laboratory data of Trials 1, 2, and 3, elevated hepatic transaminases (greater than 3 times 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).
The following adverse reactions have been identified during postapproval use of VEOZAH. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
A case of serious drug-induced hepatotoxicity with elevated transaminases (greater than 10 times the ULN at peak elevation), elevated alkaline phosphatase (greater than 4 times the ULN at peak elevation), and bilirubin (greater than 3 times the ULN at peak elevation) coupled with symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine occurred within 40 days of starting VEOZAH. After discontinuation of VEOZAH, these abnormalities gradually resolved.
VEOZAH is a substrate of CYP1A2. Concomitant use of VEOZAH with drugs that are weak, moderate, or strong CYP1A2 inhibitors, increase the plasma Cmax and AUC of VEOZAH [see CLINICAL PHARMACOLOGY].
VEOZAH is contraindicated in individuals using CYP1A2 inhibitors.
Included as part of the "PRECAUTIONS" Section
In three clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3 x the upper limit of normal (ULN) occurred in 2.3% [exposure adjusted incidence rate (EAIR) of 2.7 per 100 person-years] of women receiving VEOZAH and 0.9% (EAIR of 1.5 per 100 person-years) of women receiving placebo. No elevations in serum total bilirubin (> 2 x 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 [see ADVERSE REACTIONS].
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 [see ADVERSE REACTIONS].
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 ≥ 2 x ULN or if the total bilirubin is ≥ 2 x 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:
Discontinue VEOZAH if:
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.
Advise patients to read the FDA-approved patient labeling (PATIENT INFORMATION).
Inform patients that they will have to have a blood test to evaluate their liver function before beginning VEOZAH and while using VEOZAH monthly for the first 3 months, at 6 months, and 9 months after initialization 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 abnormalities such as new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain [see WARNINGS AND PRECAUTIONS].
Inform patients of possible serious adverse reactions of VEOZAH including hepatic transaminase elevation and liver injury [see WARNINGS AND PRECAUTIONS].
Inform patients of possible less serious but common adverse reactions of VEOZAH including abdominal pain, diarrhea, insomnia, back pain, and hot flush [see ADVERSE REACTIONS].
Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements [see DRUG INTERACTIONS].
In a 2-year female rat carcinogenicity study and a 26-week carcinogenicity study in rasH2 transgenic mice, there was no evidence of drug-related carcinogenicity at 186-fold and 47-fold the human AUC24 at the human therapeutic dose of 45 mg, respectively.
Fezolinetant showed no genotoxic potential by the bacterial reverse mutation test, chromosomal aberration test, or in vivo micronucleus test.
Fezolinetant had no effect on female fertility or early embryonic development up to 100 mg/kg/day in rats (143-fold the human AUC24 at the human therapeutic dose). In the pre- and post-natal development study in rats, the F1 male showed incomplete balanopreputial separation at doses greater than or equal to 30 mg/kg/day (36-fold the human AUC24 at the human therapeutic dose), which delayed male reproductive maturation and affected fertility. These effects were not observed following dosing at 10 mg/kg/day (11-fold the human AUC24 at the human therapeutic dose) [see Use In Specific Populations].
There are no data on VEOZAH use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In embryo-fetal toxicity animal studies with fezolinetant, embryo-lethality occurred at high doses above the human therapeutic dose in rats and rabbits, but no teratogenicity was observed. In the pre- and post-natal development animal study, delayed parturition and embryo-lethality occurred at high doses above the human therapeutic dose in rats. Additionally, in the male offspring delayed male reproductive maturation was observed, characterized by incomplete preputial separation, which affected male fertility at doses above the human therapeutic dose in rats [see Data].
In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Animal Data
In embryo-fetal development toxicity studies in rats and rabbits, embryo-lethality was noted at the highest doses (128- and 174-fold the human AUC24 at the human therapeutic dose for rats and rabbits, respectively). The no observed adverse effect level (NOAEL) for embryo-fetal development was 50 mg/kg/day in rats and 45 mg/kg/day in rabbits (62- and 16fold the human AUC24 at the human therapeutic dose for rats and rabbits, respectively). Fezolinetant showed no effects on fertility and early embryonic development in rats [see Nonclinical Toxicology].
In the pre- and post-natal development study in rats, the NOAEL for maternal and fetal toxicity was 30 mg/kg/day (36fold the human AUC24 at the human therapeutic dose) based on delayed parturition and embryo-lethality at 100 mg/kg/day. The NOAEL for F1 generation development was determined to be 100 mg/kg/day for females (204-fold the human AUC24 at the human therapeutic dose) and 10 mg/kg/day for males (11-fold the human AUC24 at the human therapeutic dose). The F1 male showed delayed male reproductive maturation, characterized as incomplete balanopreputial separation at time of mating, at doses of greater than or equal to 30 mg/kg/day (36-fold the human AUC24 at the human therapeutic dose), which affected male fertility [see Nonclinical Toxicology].
There are no data on the presence of fezolinetant in human milk, the effects on the breastfed child, or the effects on milk production. It is not known if fezolinetant is present in human milk.
Animal Data
Following administration of radiolabeled fezolinetant to lactating rats, the radioactivity concentration in milk was higher than that in the plasma at all time points, indicating that fezolinetant-derived components transferred to the tissues in infant rats via breast milk.
The efficacy and safety of VEOZAH in individuals less than 18 years of age have not been established.
There have not been sufficient numbers of geriatric women involved in clinical trials utilizing VEOZAH to determine whether those over 65 years of age differ from younger women in their response to VEOZAH.
VEOZAH is contraindicated in individuals with severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2) [see CLINICAL PHARMACOLOGY]. No dose adjustment of VEOZAH is recommended for individuals with mild (eGFR 60 to less than 90 mL/min/1.73 m2) or moderate (eGFR 30 to less than 60 mL/min/1.73 m2) renal impairment.
Child-Pugh Class A or B hepatic impairment increased the exposure of VEOZAH [see CLINICAL PHARMACOLOGY]. VEOZAH has not been studied in individuals with Child-Pugh Class C hepatic impairment.
VEOZAH is contraindicated in individuals with cirrhosis [see CLINICAL PHARMACOLOGY].
Treatment of overdose consists of discontinuation of VEOZAH therapy with institution of appropriate symptomatic care.
VEOZAH is contraindicated in women with any of the following conditions:
VEOZAH is a 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. Fezolinetant has high affinity for the NK3 receptor (Ki value of 19.9 to 22.1 nmol/L), which is more than 450-fold higher than binding affinity to NK1 or NK2 receptors.
Treatment with fezolinetant did not show any clear trends in sex hormones measured (follicle-stimulating hormone, testosterone, estrogen, and dehydroepiandrosterone sulfate) in menopausal women. Transient decrease of luteinizing hormone (LH) levels was observed at peak concentrations of fezolinetant.
At a dose 20 times the maximum approved recommended dose, fezolinetant does not prolong the QT interval to any clinically relevant extent.
In healthy women, fezolinetant Cmax and AUC increased proportionally over a dosage range from 20 to 60 mg once daily (0.44 to 1.33 times the approved recommended dosage).
Steady-state plasma concentrations of fezolinetant were reached after two once daily doses, with minimal fezolinetant accumulation.
The median (range) time to reach fezolinetant Cmax is 1.5 (1 to 4) hours in healthy women.
Effect of Food
No clinically significant differences in fezolinetant pharmacokinetics were observed following administration with a high-calorie, high-fat meal containing approximately 1000 calories (500-600 calories from fat, 250 calories from carbohydrates, and 150 calories from protein).
The mean apparent volume of distribution (Vz/F) of fezolinetant is 189 L. The plasma protein binding of fezolinetant is 51%. The blood-to-plasma ratio is 0.9.
The effective half-life (t1/2) of fezolinetant is 9.6 hours in women with vasomotor symptoms. The apparent clearance at steady-state of fezolinetant is 10.8 L/h.
Metabolism
Fezolinetant is primarily metabolized by CYP1A2 and to a lesser extent by CYP2C9 and CYP2C19. A major metabolite of fezolinetant, ES259564, was identified in plasma. ES259564 is approximately 20-fold less potent than the parent. The metabolite-to-parent ratio ranges from 0.7 to 1.8.
Excretion
Following oral administration of fezolinetant, 76.9% of the dose was excreted in urine (1.1% unchanged) and 14.7% in feces (0.1% unchanged).
There were no substantive differences in the pharmacokinetics of VEOZAH based on race and body weight (93 to 278 pounds).
Following single-dose administration of 30 mg fezolinetant, there was no effect on VEOZAH exposure (Cmax and AUC) in women with mild (eGFR 60 to less than 90 mL/min/1.73 m2) to severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment. The AUC of ES259564 (a major metabolite of fezolinetant) in women with moderate (eGFR 30 to less than 60 mL/min/1.73 m2) and severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment increased by approximately 75% and 380%, respectively. VEOZAH has not been studied in individuals with end-stage renal disease (eGFR less than 15 mL/min/1.73 m2).
Following single-dose administration of 30 mg fezolinetant in women with mild Child-Pugh Class A cirrhosis, the mean Cmax increased by 23% and AUCinf increased by 56%, relative to women with normal hepatic function. In women with moderate Child-Pugh Class B cirrhosis, the mean Cmax of fezolinetant decreased by 15% and AUCinf increased by 96%. The Cmax of ES259564 decreased in both mild and moderate cirrhosis while AUCinf and AUClast increased less than 15%. VEOZAH has not been studied in individuals with severe Child-Pugh Class C cirrhosis.
Strong CYP1A2 Inhibitors
Fezolinetant Cmax increased by 80% and AUC increased by 840% following concomitant use with fluvoxamine (strong CYP1A2 inhibitor).
Moderate CYP1A2 Inhibitors
Fezolinetant Cmax increased by 40% and AUC increased by 360% following concomitant use with mexiletine (moderate CYP1A2 inhibitor) 400 mg every 8 hours.
Weak CYP1A2 Inhibitors
Fezolinetant Cmax increased by 30% and AUC increased by 100% following concomitant use with cimetidine (weak CYP1A2 inhibitor) 300 mg every 6 hours.
No clinically significant differences in fezolinetant exposure were observed in smokers (moderate CYP1A2 inducer).
Cytochrome P450 (CYP) Enzymes
Fezolinetant and ES259564 are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Fezolinetant and ES259564 are not inducers of CYP1A2, CYP2B6, and CYP3A4.
Fezolinetant is not a substrate nor an inhibitor of P-glycoprotein (P-gp). ES259564 is a substrate of P-gp, but not an inhibitor of P-gp.
Both fezolinetant and ES259564 are not a substrate of BCRP, OATP1B1, and OATP1B3. In addition, ES259564 is not a substrate of OAT1, OAT3, OCT2, MATE1, and MATE2-K.
Repeat dose toxicity studies were conducted in intact female rats and cynomolgus monkeys. In female rats, daily administration of fezolinetant for 26 weeks at doses equal to or greater than 30 mg/kg/day (56-fold the human AUC24 at the human therapeutic dose) showed uterine atrophy and epithelial mucification of the vagina and cervix. In female cynomolgus monkeys, daily administration for 39 weeks at doses equal to or greater than 10 mg/kg/day (19-fold the human AUC24 at the human therapeutic dose) showed reduced ovarian activity.
The efficacy of VEOZAH for the treatment of moderate to severe vasomotor symptoms due to menopause was evaluated in the first 12-week, randomized, placebo-controlled, double-blind portion of each of two phase 3 clinical trials. 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.
In Trials 1 (NCT04003155) and 2 (NCT04003142), 1022 women (522 in Trial 1 and 500 in Trial 2) who had a minimum average of 7 moderate to severe vasomotor symptoms per day were randomized to one of two doses of fezolinetant (including the 45 mg dosage strength) or placebo. Randomization was stratified by smoking status.
The mean age of the postmenopausal women was 54 years. Women self-identified as Caucasian (81%), African American (17%), Asian (1%), and Hispanic/Latina ethnicity (24%). The study population included menopausal women with one or more of the following: prior hysterectomy (32.1%), prior oophorectomy (21.6%), or prior hormone therapy use (19.9%). Those who were on prior hormone therapy underwent a wash-out period prior to trial participation.
The co-primary efficacy endpoints for both trials were the mean change from baseline in moderate to severe vasomotor symptoms frequency and severity to Weeks 4 and 12. Data from each trial demonstrated statistically significant and clinically meaningful (≥ 2 hot flashes over 24 hours) reduction from baseline in the frequency of moderate to severe vasomotor symptoms for VEOZAH 45 mg compared to placebo at Weeks 4 and 12. Data from each trial also demonstrated a statistically significant reduction from baseline in the severity of moderate to severe vasomotor symptoms (over 24 hours) at Weeks 4 and 12 for VEOZAH 45 mg compared to placebo.
Results of the co-primary endpoint for change from baseline to Weeks 4 and 12 in mean frequency of moderate to severe vasomotor symptoms over 24 hours from Trials 1 and 2 are shown in Table 2.
Table 2: Mean Baseline and Change from Baseline to Weeks 4 and 12 for Mean Frequency of Moderate to Severe Vasomotor Symptoms over 24 Hours in Women Treated with VEOZAH in Trials 1 and 2
| Parameter | Trial 1 | Trial 2 | ||
| VEOZAH 45 mg (n=174) |
Placebo (n=175) |
VEOZAH 45 mg (n=167) |
Placebo (n=167) |
|
| Baseline | ||||
| Mean (SD) | 10.4 (3.92) | 10.5 (3.79) | 11.8 (8.26) | 11.6 (5.02) |
| Change from Baseline to Week 4 | ||||
| LS Mean (SE) | -5.4 (0.30) | -3.3 (0.29) | -6.3 (0.33) | -3.7 (0.33) |
| Difference vs Placebo (95% CI) | -2.1 (-2.9, -1.3) | -- | -2.6 (-3.5, -1.6) | -- |
| P-value | < 0.0011 | -- | < 0.0011 | -- |
| Change from Baseline to Week 12 | ||||
| LS Mean (SE) | -6.4 (0.31) | -3.9 (0.31) | -7.5 (0.39) | -5.0 (0.39) |
| Difference vs Placebo (95% CI) | -2.6 (-3.4, -1.7) | -- | -2.5 (-3.6, -1.5) | -- |
| P-value | < 0.0011 | -- | < 0.0011 | -- |
| 1. Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment. LS Mean: Least Squares Mean estimated from a mixed model for repeated measures analysis of covariance; SD: Standard Deviation; SE: Standard Error. |
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Results of the co-primary endpoint for change from baseline to Weeks 4 and 12 in mean severity of moderate to severe vasomotor symptoms over 24 hours from Trials 1 and 2 are shown in Table 3.
Table 3: Mean Baseline and Change from Baseline to Weeks 4 and 12 for Mean Severity of Moderate to Severe Vasomotor Symptoms over 24 Hours in Women Treated with VEOZAH in Trials 1 and 2
| Parameter | Trial 1 | Trial 2 | ||
| VEOZAH 45 mg (n=174) |
Placebo (n=175) |
VEOZAH 45 mg (n=167) |
Placebo (n=167) |
|
| Baseline | ||||
| Mean (SD) | 2.4 (0.35) | 2.4 (0.35) | 2.4 (0.34) | 2.4 (0.32) |
| Change from Baseline to Week 4 | ||||
| LS Mean (SE) | -0.5 (0.04) | -0.3 (0.04) | - 0.6 (0.05) |
2.4 (0.32) |
| Difference vs Placebo (95% CI) | -0.2 (-0.3, -0.1) | -- | -0.3 (-0.4, -0.2) | -- |
| P-value | 0.0021 | -- | < 0.0011 | -- |
| Change from Baseline to Week 12 | ||||
| LS Mean (SE) | -0.6 (0.05) | -0.4 (0.05) | - 0.8 (0.06) |
-0.5 (0.06) |
| Difference vs Placebo (95% CI) | -0.2 (-0.4, -0.1) | -- | -0.3 (-0.5, -0.1) | -- |
| P-value | 0.0071 | -- | < 0.0011 | -- |
| 1.Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment. LS Mean: Least Squares Mean estimated from a mixed model for repeated measures analysis of covariance; SD: Standard Deviation; SE: Standard Error. |
||||
In the VEOZAH 45 mg dose group across Trials 1, 2, and 3, endometrial biopsy assessments identified one case of endometrial hyperplasia and one case of endometrial malignancy. 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%.
Table 4: Incidence of Endometrial Hyperplasia or Carcinoma after 12 Months of Treatment in Trials 1, 2, and 3
| Final Diagnosis | VEOZAH 45 mg (n=350) |
Placebo (n=186) |
| Endometrial Hyperplasia and Carcinoma, n (%) | 2 (0.6%) | 0 |
| One-sided upper limit of 95% CI | 1.8% | 1.6% |
|
1 | 0 |
|
1 | 0 |
Five cases of disordered proliferative endometrium were reported in women receiving VEOZAH 45 mg and four cases were reported in women receiving placebo across the three clinical trials. The EAIR was 1.4 per 100 person-years in VEOZAH 45 mg versus 2.0 per 100 person-years in the placebo group.
VEOZAH®
(vee-O-zah)
(fezolinetant) tablets, for oral use
What is the most important information I should know about VEOZAH?
VEOZAH can cause serious side effects, including:
Stop VEOZAH right away and call your healthcare provider if you have the following signs or symptoms ofliver problems:
See “What are the possible side effects of VEOZAH?” for more information about side effects.
What is VEOZAH?
VEOZAH is a prescription medicine used to reduce moderate to severe vasomotor symptoms due to menopause. VEOZAH is not a hormone. Vasomotor symptoms are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating (“hot flashes” or “hot flushes”).
Do not use VEOZAH if you:
Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take VEOZAH?
What are the possible side effects of VEOZAH?
VEOZAH can cause serious side effects, including:
Common side effects of VEOZAH include:
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of VEOZAH.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VEOZAH?
General information about the safe and effective use of VEOZAH.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VEOZAH for a condition for which it was not prescribed. Do not give VEOZAH to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about VEOZAH. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about VEOZAH that is written for healthcare professionals.
What are the ingredients in VEOZAH?
Active ingredient: fezolinetant
Inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide
This Patient Information has been approved by the U.S. Food and Drug Administration.
