Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA

Treatment should not be started if ALT or AST is ≥2x ULN or if total bilirubin is elevated (eg, ≥2x ULN)¹

Take with liquids and swallow whole. Do not break, crush, or chew tablets. Can be taken with or without food.

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/indiviuals should return to the regular schedule the following day, a double dose should not be taken to make up for a forgotten individual dose. In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms.

Continue LFTs monthly for the first 3 months of treatment

Additional monitoring may be conducted based on clinical judgement or when symptoms suggestive of liver injury occur¹

Discontinue VEOZA if¹:

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

• Transaminase elevations >5x ULN

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

Renal impairment

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

Hepatic impairment

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

Effects of age, race, body weight, and menopause status¹

There are no clinically relevant effects of age (18 to 65 years), race (Black, Asian, Other), body weight (42 to 126 kg), or menopause status (pre-, post- menopause) on the pharmacokinetics of VEOZA.

*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.

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.

Concomitant use of hormone replacement therapy with oestrogens (local vaginal preparations excluded)¹

Concomitant use of fezolinetant and hormone replacement therapy with oestrogens has not been studied, and therefore concomitant use is not recommended.

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.