2 Clinical Trial Adverse Reactions). A causal relationship between VEOZAH and increased risk of malignancies has not been established. Known or Previous Breast Cancer or Estrogen-dependent Malignancies Women with previous or known breast cancer or other estrogen-dependent malignancies have not been included in the clinical studies.
As the efficacy and safety in this population are unknown, a decision to treat these women with VEOZAH should be based on a benefit-risk consideration for the individual. 8%). The rate of these events in the VEOZAH 45 mg dose group was ≤ 1% with the upper bound of the one-sided 95% confidence limit being ≤ 4%.
There was no case of endometrial hyperplasia or carcinoma in the placebo group. Five cases of disordered proliferative endometrium were reported in women receiving VEOZAH 45 mg and four cases were reported in women receiving placebo across the three clinical trials.
0 per 100 person-years in the placebo group. Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Oral Tablets, 45 mg fezolinetant Ferric oxide (iron oxide red), hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol (macrogol), talc, and titanium dioxide.
Product Monograph Master Template Template Date:
September 2020 <Veozah><fezolinetant> Page 7 of 27 Protected B / Protégé B Hepatic/Biliary/Pancreatic VEOZAH is contraindicated in individuals with cirrhosis. VEOZAH is not recommended for use in individuals with Child-Pugh Class B (moderate) chronic hepatic impairment.
3 Pharmacokinetics – Special Populations and Conditions – Hepatic Insufficiency). 5 per 100 person- years) of women receiving placebo in three clinical trials. No elevations in serum total bilirubin (greater than 2 times the ULN) occurred.
Women with ALT or AST elevations were generally asymptomatic. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry, and Other Quantitative Data). In the post-marketing setting, cases of serious but reversible hepatotoxicity have been reported within the first few weeks of treatment.
5 Post-Market Adverse Reactions). Perform baseline bloodwork to evaluate hepatic function and assess for injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if ALT or AST is equal to or exceeds 2 times the ULN or if the total bilirubin is elevated.
5 x ULN and < 2 x ULN. Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy. Patients who experience signs or symptoms that may suggest liver injury such as new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain should discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests.
Discontinue VEOZAH if transaminase elevations are greater than 5 times the ULN and/or transaminase elevations are greater than 3 times the ULN and the total bilirubin level is greater than 2 times the ULN. If transaminase elevations greater than 3 times the ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.
Exclude alternative causes of hepatic laboratory test elevations.
Product Monograph Master Template Template Date:
September 2020 <Veozah><fezolinetant> Page 8 of 27 Protected B / Protégé B Monitoring and Laboratory Test Monitoring for signs and symptoms of liver injury should be done during treatment with VEOZAH (see 7 WARNINGS AND PRECAUTIONS – Hepatic/Biliary/Pancreatic).
73 m2) renal impairment. 3 Pharmacokinetics – Special Populations and Conditions – Renal Insufficiency).
Reproductive Health:
Female and Male Potential • Fertility There are no data on the effect of VEOZAH on human fertility. In the fertility study in female rats, fezolinetant did not affect fertility (see 16 NON-CLINICAL TOXICOLOGY – Reproductive and Developmental Toxicity).
1 Pregnant Women VEOZAH is contraindicated in pregnant women. There are no data on the use of VEOZAH in pregnant women. In embryo-fetal toxicity animal studies with fezolinetant, embryo-lethality occurred at high doses […]