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IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
COLLAPSE
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
CONTRAINDICATIONS
VEOZAH is contraindicated in women with any of the following:
- Known cirrhosis
- Severe renal impairment or end-stage renal disease
- Concomitant use with CYP1A2 inhibitors
VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
CONTRAINDICATIONS
VEOZAH is contraindicated in women with any of the following:
- Known cirrhosis
- Severe renal impairment or end-stage renal disease
- Concomitant use with CYP1A2 inhibitors
INDICATIONS AND USAGE
VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
WARNINGS AND PRECAUTIONS
Hepatic Transaminase Elevation and Hepatotoxicity
In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x the upper limit of normal (ULN) occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo. No elevations in serum total bilirubin (> 2x ULN) occurred. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Women with cirrhosis were not studied.
In the postmarketing setting, a case of acute mixed hepatocellular cholestatic drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin with symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine occurred in a woman receiving VEOZAH. The individual’s signs and symptoms gradually resolved after discontinuation of the drug.
Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if the concentration of ALT or AST is ≥ 2x ULN or if the total bilirubin is elevated (e.g., ≥ 2x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is < 2x ULN and the total bilirubin is normal, VEOZAH can be started.
Perform follow-up hepatic laboratory tests monthly for 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: New onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or upper right quadrant pain.
Discontinue VEOZAH if:
- Transaminase elevations are > 5x ULN
- Transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN
If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.
Exclude alternative causes of hepatic laboratory test elevations.
ADVERSE REACTIONS
The most common adverse reactions with VEOZAH ≥ 2% and > placebo (VEOZAH % vs. placebo %) are: abdominal pain (4.3% vs. 2.1%), diarrhea (3.9% vs. 2.6%), insomnia (3.9% vs. 1.8%), back pain (3.0% vs. 2.1%), hot flush (2.5% vs. 1.6%), and hepatic transaminase elevation (2.3% vs. 0.8%).
Please click here for full Prescribing Information for VEOZAH (fezolinetant).