The CSFQ-14 is a validated scale that measures sexual functioning, including the 3 phases of the sexual response cycle:
INDICATION: TRINTELLIX is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
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Individual results may vary.
TRINTELLIX is indicated for the
Disorder (MDD) in adults.
Common adverse reactions occurring in ≥2% of patients treated with TRINTELLIX and at least 2% greater than the incidence in placebo-treated patients in 6- to 8-week trials*1
*Based on the rates for 5-, 10-, 15- and 20-mg doses.1
†Includes pruritus generalized.1
Effect on body weight in randomized, double-blind, placebo-controlled studies10,11
8-week placebo-controlled studies1Short-term: TRINTELLIX 5 mg/day to 20 mg/day had no significant effect on body weight as measured by the mean change from baseline in 6- to
Long-term: In the 6-month, double-blind, placebo-controlled phase of the Non-US long-term study in patients who had responded to TRINTELLIX during the initial 12-week, open-label phase, there was no significant effect on body weight between TRINTELLIX and placebo-treated patients1
A switch to TRINTELLIX resulted in a statistically superior improvement in treatment-emergent sexual dysfunction vs escitalopram while both drugs maintained antidepressant efficacy.1,13
Mean change from baseline in CSFQ-14 total score1,13
At Week 8, improvement in SSRI-induced sexual dysfunction in MDD patients switched to TRINTELLIX was superior to improvement in patients who switched to escitalopram.1
Both TRINTELLIX and escitalopram maintained antidepressant efficacy during the study.1,13
Mean change from baseline in MADRS total score
Voluntary reports with TRINTELLIX were ≤5% in 6- to 8-week placebo-controlled studies*1
*Voluntarily reported adverse reactions related to sexual dysfunction were captured as individual event terms and aggregated to report overall incidence.1
Prospectively assessed rates of adverse sexual reactions1
Incidence of adverse sexual reactions using ASEX in patients without sexual dysfunction at baseline in 7 placebo-controlled studies
†Incidence based on the number of subjects with sexual dysfunction during the study/number of subjects without sexual dysfunction at baseline (approximately 1/3 of the population across all study groups).1 Sexual dysfunction was defined as a subject scoring any of the following on the ASEX scale at 2 consecutive visits during the study: total score ≥19; any single item ≥5; or 3 or more items each with a score of ≥4.
Abbreviation: ASEX, Arizona Sexual Experiences Scale.
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The most commonly observed adverse reactions for TRINTELLIX in 6- to 8-week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation, and vomiting.
Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.
Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to TRINTELLIX in the third trimester for PPHN and drug discontinuation syndrome.
TRINTELLIX is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
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There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/