Full Prescribing Information Patient Information

SAVE ON VEOZAH

For moderate to severe Vasomotor Symptoms (VMS) due to menopause

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<p>CONSUMER IMPORTANT SAFETY INFORMATION (ISI) for VEOZAH (fezolinetant)<p>

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VEOZAH?
VEOZAH can cause serious side effects, including:
  • Liver Problems. 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 monthly for the first 3 months, at month 6, and month 9 after you start taking VEOZAH or if you have signs or symptoms that suggest liver problems. If your liver blood test values are elevated, your healthcare provider may advise you to stop treatment or request additional liver blood tests.

What is VEOZAH™ (fezolinetant)?

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”).

Stop VEOZAH right away and call your healthcare provider if you have the following signs or symptoms of liver problems:

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

 

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 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.

 

The most common side effects of VEOZAH include:

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

 

These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away.


Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see full Prescribing Information and Patient Information, including BOXED WARNING.