Brand Name
Veozah
Generic Name
Fezolinetant
View Brand Information FDA approval date: May 12, 2023
Classification: Neurokinin 3 Receptor Antagonist
Form: Tablet
What is Veozah (Fezolinetant)?
VEOZAH ® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. VEOZAH is a neurokinin 3 receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Approved To Treat
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A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy
Summary: One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the s...
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Brand Information
VEOZAH (fezolinetant)
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 ≥ 2 x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2 x 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 > 5 x ULN, or if 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 (
1INDICATIONS AND USAGE
VEOZAH
2DOSAGE FORMS AND STRENGTHS
Tablets: 45 mg, round, light red, film-coated tablets, debossed with the Astellas logo and ‘645’ on the same side.
3CONTRAINDICATIONS
VEOZAH is contraindicated in women with any of the following conditions:
- Known cirrhosis
- Severe renal impairment or end-stage renal disease
- Concomitant use with CYP1A2 inhibitors
4ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hepatic Transaminase Elevation and Hepatotoxicity
4.1Clinical Trials Experience
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
In the pooled laboratory data of Trials 1, 2, and 3, elevated hepatic transaminases (> 3 x 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).
4.2Postmarketing Experience
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.
Hepatic: Cases of serious drug-induced hepatotoxicity occurred within 40 days of starting VEOZAH. Patients experienced elevated transaminases (up to 50 x ULN at peak elevation), elevated alkaline phosphatase (up to 4 x ULN at peak elevation), and bilirubin (up to 5 x 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.
5OVERDOSAGE
Treatment of overdose consists of discontinuation of VEOZAH therapy with institution of appropriate symptomatic care.
6DESCRIPTION
VEOZAH (fezolinetant) is a small-molecule NK3 receptor antagonist.
The chemical name of fezolinetant is (4-Fluorophenyl)[(8
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.
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
Evaluation of Hepatic Injury During Treatment with VEOZAH
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
Serious Adverse Reactions with VEOZAH
Inform patients of possible serious adverse reactions of VEOZAH including hepatic transaminase elevation and liver injury
Common Adverse Reactions with VEOZAH
Inform patients of possible less serious but common adverse reactions of VEOZAH including abdominal pain, diarrhea, insomnia, back pain, and hot flush
Drug Interactions
Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements
Distributed by:
Astellas Pharma US, Inc.
Northbrook, IL 60062
© 2024 Astellas Pharma US, Inc. or its affiliates
432095-VEO-USA
8Package/Label Display Panel – VEOZAH Bottle Carton Label
NDC 0469-2660-30
VEOZAH
30 tablets
9Package/Label Display Panel – VEOZAH Sample Bottle Carton Label
NDC 0469-2460-07
PROFESSIONAL SAMPLE-NOT FOR SALE
Rx Only
VEOZAH
7 tablets
10Package/Label Display Panel- VEOZAH Sample Blister Carton Label
NDC 0469-2760-07
PROFESSIONAL SAMPLE-NOT FOR SALE
Rx Only
VEOZAH
7 tablets