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The adverse event reporting information can be found by scrolling to the bottom of this page.

 

VEOZA (fezolinetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.1

VMS are also known as hot flushes* and night sweats.2

Dosing banner

Dosing and administration1

Dosing and administration
Medical examination/consultation

Medical examination/ consultation1

Prior to the initiation or reinstitution of VEOZA, a careful diagnosis should be made, and complete medical history (including family history) must be taken.

 

Liver function tests (LFTs) must be performed prior to treatment initiation with fezolinetant.

 

Treatment should not be started if alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2 x upper limit of normal (ULN) or if total bilirubin is elevated (e.g., ≥ 2 x ULN). LFTs must be performed monthly during the first three months of treatment, then based on clinical judgement. LFTs must also be performed when symptoms suggestive of liver injury occur.

 

Treatment should be discontinued in the following situations:

  • Transaminase elevations are ≥ 3 x ULN with: total bilirubin > 2 x ULN OR symptoms of liver injury.
  • Transaminase elevations > 5 x ULN.

Monitoring of liver function should be maintained until they have normalised.

 

During treatment, periodic check-ups must be carried out according to standard clinical practice.
 

Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately once these occur.

45 mg orally once daily

45 mg orally once daily1

Taken with liquids and swallowed whole. Tablets are not to be broken, crushed or chewed. Can be taken with or without food.

About the same time each day, taken every day

About the same time each day, taken every day1

If a dose is missed or not taken at the usual time, patients should take the missed dose as soon as possible on the same day, unless there are fewer than 12 hours before the next scheduled dose. Patients/individuals should return to the regular schedule the following day.

Management of overdose

Management of overdose1

In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms.

The benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual

The benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual1

Special populations

Special populations1


Renal impairment

VEOZA is not recommended for use in individuals with severe renal impairment** or end-stage renal disease.† No dose modification is recommended in mild/moderate‡ renal impairment.

 

Hepatic impairment

VEOZA is not recommended for use in individuals with Child-Pugh Class B or C (moderate or severe chronic hepatic impairment). No dose adjustment is recommended in Child-Pugh Class A (mild) chronic hepatic impairment.

 

Known or previous breast cancer or oestrogen-dependent malignancies:
  • Women undergoing oncologic treatment (e.g., chemotherapy, radiation therapy, anti-hormone therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, VEOZA is not recommended for use in this population as the safety and efficacy are unknown
  • Women with previous breast cancer or other oestrogen-dependent malignancies and no longer on any oncologic treatment have not been included in the clinical studies. A decision to treat these women with VEOZA should be based on a benefit-risk consideration for the individual
Elderly

Fezolinetant has not been studied for safety and efficacy in women initiating VEOZA treatment over 65 years of age. No dose recommendation can be made for this population.

Bring the VMS conversation back to your practice

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*Hot flushes are also known as hot flashes.4

**eGFR less than 30 ml/min/1.73 m2.

†End-stage renal disease is eGFR below 15 ml/min/1.73 m2.

‡Mild renal impairment is defined as eGFR 60 to less than 90 ml/min/1.73 m2. Moderate renal impairment is defined as eGFR 30 to less than 60 ml/min/1.73 m2.

eGFR: estimated glomerular filtration rate.
 

REFERENCES: 1. VEOZA Summary of Product Characteristics. 2. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician’s Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55. 3. VEOZA Patient Information Leaflet. 4. Depypere H, Lademacher C, Siddiqui E, et al. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs 2021;30(7):681-94.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Astellas Pharma Ltd. on 0800 783 5018.

MAT-GB-VEO-2024-00242. February 2025