Gepirone: uses, dosing, side effects & brands

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1) ] QT Prolongation [see Warnings and Precautions (5.2) ] Serotonin Syndrome [see Warnings and Precautions (5.3) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence of ≥ 5% and at least twice incidence of placebo) were dizziness, nausea, insomnia, abdominal pain, and dyspepsia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Aytu Therapeutics at 1-855-298-8246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During premarketing assessment, multiple doses of EXXUA were administered to 1,976 adult patients with major depressive disorder (MDD) in controlled phase 2 and 3 clinical studies, including 1,639 patients in placebo-controlled phase 2 and 3 trials in MDD, with 237 patients exposed for over six months. The population treated with EXXUA in the pooled placebo-controlled studies ranged from 15 to 78 years of age, was 34%…

EXXUA is contraindicated in patients: with known hypersensitivity to gepirone or components of EXXUA [see Adverse Reactions (6.1) ] . with prolonged QTc interval > 450 msec at baseline [see Warnings and Precautions (5.2) ]. with congenital long QT syndrome [see Warnings and Precautions (5.2) ]. receiving concomitant strong CYP3A4 inhibitors [see Warnings and Precautions (5.2) and Drug Interactions (7) ]. with severe hepatic impairment [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7) ]. taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome [see Warnings and Precautions (5.3) and Drug Interactions (7) ] . Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated. Known hypersensitivity to gepirone or components of EXXUA ( 4 ). Prolonged QTc interval > 450 msec at baseline ( 4 ). Congenital long QT syndrome ( 4 ). Concomitant use of strong CYP3A4 inhibitors ( 4 ). Severe hepatic impairment ( 4 ). Use with an MAOI or within 14 days of stopping treatment with EXXUA. Do not use EXXUA within 14 days of discontinuing an MAOI ( 4 ).

Table 3 displays clinically important drug interactions with EXXUA. Table 3 Clinically Important Drug Interactions with EXXUA CYP3A4 Inhibitors Clinical Impact Strong CYP3A4 Inhibitors Concomitant use of EXXUA with a strong CYP3A4 inhibitor increases EXXUA exposure by ~ 5-fold [see Clinical Pharmacology (12.3) ] . Moderate CYP3A4 Inhibitors Concomitant use with a moderate CYP3A4 inhibitor increases EXXUA exposure by ~ 2.6-fold [see Clinical Pharmacology (12.3) ] . Intervention Strong CYP3A4 Inhibitors EXXUA is contraindicated in patients taking strong CYP3A4 inhibitors [see Dosage and Administration (2.7) , Contraindications (4) , and Warnings and Precautions (5.2) ] . Moderate CYP3A4 Inhibitors If EXXUA is used with a moderate CYP3A4 inhibitor, reduce the dosage of EXXUA [see Dosage and Administration (2.7) and Warnings and Precautions (5.2) ]. Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of EXXUA with MAOIs increases the risk of serotonin syndrome. Intervention EXXUA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue or in patients who have taken MAOIs within the preceding 14 days. Allow at least 14 days after stopping EXXUA before starting an MAOI [see Dosage and Administration (2.8) , Contraindications (4) , and Warnings and Precautions (5.3) ]. Drugs that Prolong the QTc Interval Clinical Impact Concomitant use of drugs that prolong the QTc interval may add to the QTc prolonging effects of EXXUA and increase the risk of cardiac arrhythmias. Intervention Monitor patients with ECGs more frequently if EXXUA is administered with other drugs known to prolong QT interval [see Warnings and Precautions (5.2) ] . CYP3A4 Inducers Clinical Impact Concomitant use of EXXUA with a strong CYP3A4 inducer reduces EXXUA exposure by 20- to 29-fold [see Clinical Pharmacology (12.3) ] . Intervention Avoid concomitant use of EXXUA in patients taking strong CYP3A4 inducers. Other Serotonergic Drugs Clinical Impact Concomitant use of EXXUA and serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when EXXUA is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of EXXUA and/or concomitant serotonergic drug [see Warnings and Precautions (5.3) ] . Strong CYP3A4 inducers: Reduces EXXUA exposure. Avoid concomitant use ( 7 ).