Fezolinetant

What is Fezolinetant?

• Fezolinetant (Veozah), is a small-molecule NK3 receptor antagonist.

Fezolinetant

What are the uses of this medicine?

• 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”).

How does this medicine work?

• 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, which is more than 450-fold higher than binding affinity to NK1 or NK2 receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have cirrhosis.
• have severe kidney problems or kidney failure.
• are taking certain medicines called CYP1A2 inhibitors.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking Veozah.
• 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.

Be sure to mention any of the following:

• CYP1A2 Inhibitors

• Veozah is contraindicated in individuals using CYP1A2 inhibitors.

Is this medicine FDA approved?

• Fezolinetant was approved for medical use in the United States in May 2023.
• Fezolinetant is the first neurokinin 3 (NK3) receptor antagonist approved by the US Food and Drug Administration (FDA) to treat moderate to severe hot flashes from menopause.

How should this medicine be used?

• Perform baseline bloodwork to evaluate for hepatic function and injury including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), and serum bilirubin (total and direct) before initiating treatment with Veozah.

Recommended dosage:

• Take a single 45 mg Veozah tablet orally once daily with or without food.

Administration:

• 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 45 mg

This medicine is available in fallowing brand namesː

• Veozah

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Less common, but serious side effects may include:

• increased liver blood test values

What special precautions should I follow?

• Elevations in serum transaminase concentrations greater than three times the upper limit of normal (ULN) occurred in the clinical trials. Perform bloodwork prior to initiation of Veozah to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the ULN. Perform follow-up evaluations of hepatic transaminase concentration at 3 months, 6 months, and 9 months after initiation of therapy.
• 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.
• Inform patients of possible serious adverse reactions of Veozah including hepatic transaminase elevation.
• Inform patients of possible less serious but common adverse reactions of Veozah including abdominal pain, diarrhea, insomnia, back pain, and hot flush.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment of overdose consists of discontinuation of Veozah therapy with institution of appropriate symptomatic care.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The efficacy and safety of Veozah in individuals less than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• 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

Who manufactures and distributes this medicine?

Distributed by:

• Astellas Pharma US, Inc.
• Northbrook, IL

• Veozah is a trademark of Astellas US LLC.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Fezolinetant
• FDA Fezolinetant

Fezolinetant Resources
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