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VEOZAH is a brand name for Fezolinetant, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VEOZAH (fezolinetant film-coated tablets) is indicated for: • The treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 1.1 Pediatrics Pediatrics (< 18 years of age): VEOZAH is not indicated for pediatric use. No data are available to Health Canada. 1.2 Geriatrics Geriatrics (≥ 65 years…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Perform baseline bloodwork to evaluate hepatic function and assess for injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with VEOZAH.
Do not start VEOZAH if ALT or AST is equal to or exceeds 2 times the upper limit of normal (ULN) or if the total bilirubin is elevated (is equal to or exceeds 2 x ULN). 5 x ULN and < 2 x ULN (see 7 WARNINGS AND PRECAUTIONS – Hepatic Transaminase Elevation and Hepatotoxicity).
While using VEOZAH, perform follow-up evaluations of hepatic transaminase concentration monthly during the first 3 months, at 6 months, and 9 months after initiation of therapy. Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (see 7 WARNINGS AND PRECAUTIONS – Hepatic Transaminase Elevation and Hepatotoxicity).
2 Recommended Dose and Dosage Adjustment The recommended dose of VEOZAH is 45 mg once daily.
Hepatic Impairment:
VEOZAH is contraindicated in individuals with cirrhosis. VEOZAH is not recommended for use in individuals with Child-Pugh Class B (moderate) chronic hepatic impairment. VEOZAH has not been studied in individuals with Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population.
3 Pharmacokinetics – Special Populations and Conditions – Hepatic Insufficiency). 73 m2) renal impairment. 73 m2) and is contraindicated in this population. 3 Pharmacokinetics – Special Populations and Conditions – Renal Insufficiency).
1 Pediatrics). 2 Geriatrics). 4 Administration VEOZAH should be administered orally once daily at about the same time each day with or without food, taken with liquids, and should be swallowed whole. Do not cut, crush, or chew tablets.
5 Missed Dose If a dose of VEOZAH is missed or not taken at the usual time, administer the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose. Return to the regular schedule the following day.
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.
– Hepatic/Biliary/Pancreatic). • with severe renal impairment or end-stage renal disease (see 7 WARNINGS AND PRECAUTIONS – Renal). 2 Drug Interactions Overview). 1 Dosing Considerations Perform baseline bloodwork to evaluate hepatic function and assess for injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with VEOZAH.
Do not start VEOZAH if ALT or AST is equal to or exceeds 2 times the upper limit of normal (ULN) or if the total bilirubin is elevated (is equal to or exceeds 2 x ULN). 5 x ULN and < 2 x ULN (see 7 WARNINGS AND PRECAUTIONS – Hepatic Transaminase Elevation and Hepatotoxicity).
While using VEOZAH, perform follow-up evaluations of hepatic transaminase concentration monthly during the first 3 months, at 6 months, and 9 months after initiation of therapy. Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (see 7 WARNINGS AND PRECAUTIONS – Hepatic Transaminase Elevation and Hepatotoxicity).
2 Recommended Dose and Dosage Adjustment The recommended dose of VEOZAH is 45 mg once daily.
Hepatic Impairment:
VEOZAH is contraindicated in individuals with cirrhosis. VEOZAH is not recommended for use in individuals with Child-Pugh Class B (moderate) chronic hepatic impairment. VEOZAH has not been studied in individuals with Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population.
3 Pharmacokinetics – Special Populations and Conditions – Hepatic Insufficiency). 73 m2) renal impairment. 73 m2) and is contraindicated in this population. 3 Pharmacokinetics – Special Populations and Conditions – Renal Insufficiency).
VEOZAH is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING.
• with known cirrhosis (see 7 WARNINGS AND PRECAUTIONS – Hepatic/Biliary/Pancreatic). • with severe renal impairment or end-stage renal disease (see 7 WARNINGS AND PRECAUTIONS – Renal). 2 Drug Interactions Overview). •
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]
1 Pediatrics). 2 Geriatrics). 4 Administration VEOZAH should be administered orally once daily at about the same time each day with or without food, taken with liquids, and should be swallowed whole. Do not cut, crush, or chew tablets.
5 Missed Dose If a dose of VEOZAH is missed or not taken at the usual time, administer the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose. Return to the regular schedule the following day.
5 OVERDOSAGE There is no experience with inadvertent VEOZAH overdose. Oral doses of VEOZAH up to 900 mg as a single-dose and 720 mg as once daily for 7 days have been tested in clinical studies in healthy women. The maximum tolerated dose was determined to be 900 mg.
At 900 mg, headache, nausea, and paresthesia were observed. In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms. For management of a suspected drug overdose, contact your regional Poison Control Centre.
Product Monograph Master Template Template Date:
September 2020 <Veozah><fezolinetant> Page 6 of 27 Protected B / Protégé B 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition, and Packaging VEOZAH 45 mg tablets are round, light red, film-coated tablets debossed with the Astellas logo and ‘645’ on the same side.
The tablets are available in PA/ Aluminum /PVC/ Aluminum unit dose blister of 30 film-coated tablets (10 tablets x 3 blister). 7 WARNINGS AND PRECAUTIONS Carcinogenesis and Mutagenesis A numerical imbalance was observed in the incidence of other malignancies between VEOZAH and placebo groups reported in the long-term safety study [2693-CL-0304] (see