Fluvoxamine (a selective serotonin reuptake inhibitor [SSRI]) and viloxazine (a serotonin and norepinephrine reuptake inhibitor [SNRI]) are examples of CYP1A2 inhibitors. Fezolinetant is contraindicated in individuals using CYP1A2 inhibitors
Placeboc (n = 952) | Fezolinetant 30 mg Totald (n = 1103) | Fezolinetant 45 mg Totale (n = 1100) | |
---|---|---|---|
SSRIs (total) | 74 (7.8%) | 86 (7.8%) | 64 (5.8%) |
Citalopram / citalopram hydrobromide | 27 (2.8%) | 20 (1.8%) | 25 (2.3%) |
Escitalopram / escitalopram oxalate | 13 (1.4%) | 16 (1.5%) | 14 (1.3%) |
Fluoxetine / fluoxetine hydrochloride | 10 (1.1%) | 20 (1.8%) | 11 (1.0%) |
Paroxetine / paroxetine hydrochloride | 5 (0.5%) | 7 (0.6%) | 4 (0.4%) |
Sertraline / sertraline hydrochloride | 21 (2.2%) | 26 (2.4%) | 12 (1.1%) |
SNRIs (total) | 31 (3.3%) | 36 (3.3%) | 33 (3.0%) |
Desvenlafaxine / desvenlafaxine succinate monohydrate | 3 (0.3%) | 4 (0.4%) | 3 (0.3%) |
Duloxetine / duloxetine hydrochloride | 12 (1.3%) | 11 (1.0%) | 14 (1.3%) |
Levomilnacipran hydrochloride | 1 (0.1%) | 0 | 0 |
Venlafaxine / venlafaxine hydrochloride | 15 (1.6%) | 21 (1.9%) | 16 (1.5%) |
a Concomitant medications are defined as any medications that participants took after the first dose of study medication and either up to 30 days from last dose of study drug or first dose of study drug during the extension period, whichever came sooner.
b SAF: All randomized participants assessed according to the treatment they received at first dose.
c Placebo includes 175 participants from SKYLIGHT 1 and 167 participants from SKYLIGHT 2 who received placebo for 12 weeks, and 610 participants who received placebo for 52 weeks in SKYLIGHT 4.
d Fezolinetant 30 mg Total includes 152 participants who received fezolinetant 30 mg for 40 weeks (re-randomized after Week 12 from placebo to fezolinetant 30 mg for the active treatment extension period in SKYLIGHT 1 and 2), and 951 participants who received fezolinetant 30 mg for 52 weeks in SKYLIGHT 1, 2 and 4.
e Fezolinetant 45 mg Total includes 151 participants who received fezolinetant 45 mg for 40 weeks (re-randomized after Week 12 from placebo to fezolinetant 45 mg for the active treatment extension period in SKYLIGHT 1 and 2), and 949 participants who received fezolinetant 45 mg for 52 weeks in SKYLIGHT 1, 2, and 4.
Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers. FDA. Available at: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Accessed 3JUN2024.
Lexidrug Online. Inhibitors and Inducers of Cytochrome P450 Enzymes (Lexi-Drugs). Available at: https://online.lexi.com/lco/action/home. Accessed 19APR2024.
Drug Interactions Flockhart TableTM. Indiana University. Available at: https://drug-interactions.medicine.iu.edu/MainTable.aspx. Accessed 19APR2024.
VEOZAH [package insert]. Northbrook, IL, USA: Astellas Pharma, Inc. Available at: https://www.astellas.com/us/system/files/veozah_uspi.pdf.
Lexicomp Online. Inhibitors and Inducers of Cytochrome P450 Enzymes (Lexi-Drugs). Available at: https://online.lexi.com/lco/action/home.
Data on file.
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