VEOZAH (Page 4 of 5)

14.2 Effects on Endometrium in Postmenopausal Women

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


45 mg




Endometrial Hyperplasia and Carcinoma, n (%)

One-sided upper limit of 95% CI

— Simple hyperplasia without atypia

— Endometrial adenocarcinoma

2 (0.6%)








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.


16.1 How Supplied

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:

Bottles of 30 tablets with child resistant closure and desiccant, (NDC 0469-2660-30)
Bottles of 90 tablets with child resistant closure and desiccant, (NDC 0469-2660-90)

16.2 Storage and Handling

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].


Advise patients to read the FDA-approved patient labeling (Patient Information).

Evaluation of Liver Enzymes with VEOZAH

Inform patients that they will have to have a blood test to evaluate their liver before beginning VEOZAH and while using VEOZAH at 3 months, 6 months, and 9 months of use, and when clinically indicated to evaluate symptoms of liver abnormalities such as nausea, vomiting, or yellowing of the skin or eyes [see Warnings and Precautions (5.1)].

Serious Adverse Reactions with VEOZAH

Inform patients of possible serious adverse reactions of VEOZAH including hepatic transaminase elevation [see Warnings and Precautions (5.1)].

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 [see Adverse Reactions (6.1)].

Drug Interactions

Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements [see Drug Interactions (7.1)].

Distributed by:

Astellas Pharma US, Inc.

Northbrook, IL 60062

VEOZAH is a trademark of Astellas US LLC.

© 2023 Astellas Pharma US, Inc.


VEOZAH (vee-O-zah)


tablets, for oral use

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:

have cirrhosis.
have severe kidney problems or kidney failure.
are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure.

Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you:

have liver disease or liver problems.
have kidney problems.
have any medical conditions that may become worse while you are using VEOZAH.

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?

Take VEOZAH exactly as your healthcare provider tells you to take it.
Take 1 VEOZAH tablet by mouth with or without food at about the same time each day.
Swallow the VEOZAH tablet whole with liquid. Do not cut, crush, or chew the tablet.
If you miss a dose of VEOZAH, take the missed dose as soon as possible on the same day, with at least 12 hours before the next scheduled dose. Return to your normal schedule the following day.

What are the possible side effects of VEOZAH?

VEOZAH can cause serious side effects, including:

increased liver blood test values. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test at month 3, month 6, and month 9 after you start taking VEOZAH.

Call your healthcare provider right away if you have the following signs and symptoms of liver problems:

yellowing of the eyes or skin (jaundice)
pain in the right upper stomach (abdomen)

Common side effects of VEOZAH include:

stomach (abdominal) pain
difficulty sleeping (insomnia)
back pain
hot flashes or hot flushes

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?

Store VEOZAH at room temperature between 68°F to 77°F (20°C to 25°C).
Dispose of the unused medicine through a take-back option, if available. See for more information.
Keep VEOZAH and all medicines out of the reach of children.

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

Distributed by:

Astellas Pharma US, Inc.

Northbrook, IL 60062

VEOZAH is a trademark of Astellas US LLC.

© 2023 Astellas Pharma US, Inc.

For more information, go to or call 1-800-727-7003.

This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: 5/2023

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