Veozah

Veozah is a nonhormonal prescription medicine used to reduce moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause.

Before a woman enters menopause, a balance exists between the estrogen hormones and a brain chemical called neurokinin B (NKB), that works to regulate the body’s temperature. During menopause, estrogen levels decline and this balance is disrupted, leading to vasomotor symptoms.

Veozah contains a drug called fezolinetant. Fezolinetant is a neurokinin 3 (NK3) receptor antagonist that works to reduce the frequency and intensity of hot flashes by restoring the balance between estrogen and NKB by blocking NKB in the temperature control center of the brain.

Veozah is used for the treatment of moderate to severe vasomotor symptoms due to menopause.

Vasomotor symptoms are intense feelings of heat ("hot flashes" or "hot flushes"), night sweats, and feelings of warmth in the face, neck, and chest that can occur frequently in women transitioning through menopause.

Menopause is the natural change in a woman’s life when her period stops, usually between the ages 45 and 55. Up to 80% of menopausal women are thought to experience hot flashes, which can include periods of sweating, flushing and chills lasting for several minutes.

• Take Veozah tablets exactly as your healthcare provider tells you to take it.
• Take one Veozah tablet by mouth with or without food at about the same time each day.
• Swallow the tablet whole with liquid. Do not cut, crush, or chew the tablet.
• If you miss a dose, 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.

RISKS OF HEPATOTOXICITY

Using Veozah has a risk of hepatotoxicity.

It is important to have a liver laboratory tests before starting treatment to check your liver function and any signs of liver injury.

• You should have follow-up liver laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
• Patients will be advised to stop 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).
• Do not start VEOZAH if either aminotransferase is ≥ 2 x ULN or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory.
• 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.

Do not use Veozah if you:

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

Before you start treatment, 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 during treatment.

Pregnancy

There are no data for Veozah use during pregnancy.

Breastfeeding

There are no data for Veozah use during breastfeeding.

The most common side effects of Veozah include:

• stomach (abdominal) pain
• diarrhea
• difficulty sleeping (insomnia)
• back pain
• hot flashes (also called hot flushes).

Serious side effects and warnings

Veozah can cause serious side effects, including serious liver injury and increased liver blood test values.

Veozah can cause rare but serious liver injury. Your healthcare provider will do a blood test to check your liver before you start treatment and repeat this monthly for the next 2 months, and then at months 3, 6, and 9 of treatment. Stop Veozah and call your healthcare provider right away if you have the following signs or symptoms of liver problems:

• feeling more tired than you do usually
• nausea
• vomiting
• itching
• yellowing of the eyes or skin (jaundice)
• pale feces
• dark urine
• pain in the right upper stomach (abdomen).

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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Vasomotor Symptoms Due to Menopause

45 mg orally once daily

Use: - treatment of moderate to severe vasomotor symptoms due to menopause.

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 vice versa. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Especially tell your healthcare provider if you are taking certain medicines called CYP1A2 inhibitors.

CYP1A2 inhibitors include:

• fluvoxamine
• ciprofloxacin
• enoxacin
• methoxsalen
• mexiletine
• oral contraceptives
• vemurafenib
• acyclovir
• allopurinol
• cimetidine
• peginterferon alpha-2a
• piperine
• zileuton

• Store the tablets 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 www.fda.gov/drugdisposal for more information.

Keep all medicines out of the reach of children and pets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

This page summarizes the most important information. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

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