EXXUA

GEPIRONE

Manufacturer: Fabre Kramer Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

EXXUA (gepirone) is an antidepressant medication used for the treatment of major depressive disorder (MDD) in adults. The recommended starting dose is 18.2 mg administered orally once daily with food, and the dosage may be increased based on clinical response and tolerability. EXXUA is contraindicated in patients with known hypersensitivity to gepirone, prolonged QTc interval, congenital long QT syndrome, and those receiving concomitant strong CYP3A4 inhibitors. The most common adverse reactions include dizziness, nausea, insomnia, abdominal pain, and dyspepsia. EXXUA is not approved for use in pediatric patients, and its use during pregnancy should be carefully considered due to potential risks to the fetus.

Key Clinical Findings and Indications

EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults
The mechanism of action is thought to be related to its modulation of serotonergic activity in the CNS through selective agonist activity at 5HT1A receptors

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients

Contraindications

Known hypersensitivity to gepirone or components of EXXUA
Prolonged QTc interval > 450 msec at baseline
Congenital long QT syndrome
Receiving concomitant strong CYP3A4 inhibitors
Severe hepatic impairment
Use with an MAOI or within 14 days of stopping treatment with EXXUA

Adverse Reactions

Dizziness
Nausea
Insomnia
Abdominal pain
Dyspepsia

Dosing Recommendations

General Guidance

Reduce the EXXUA dose by 50% when used concomitantly with a moderate CYP3A4 inhibitor

Major depressive disorder (MDD)

Adult Dose

18.2 mg orally once daily with food, titrated to 36.3 mg, 54.5 mg, or 72.6 mg once daily based on clinical response and tolerability

Pediatric Dose

Special Population Considerations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including EXXUA, during pregnancy
Based on animal reproduction studies, gepirone has been shown to have adverse effects on embryo/fetal and postnatal development

Nursing Mothers

Pediatric Use

The safety and effectiveness of EXXUA in pediatric patients have not been established for the treatment of MDD
Efficacy was not demonstrated in two 8-week, randomized, placebo-controlled trials in 426 pediatric patients 7 to 17 years of age with MDD

Geriatric Use

Of the 1,639 patients exposed to EXXUA in placebo-controlled clinical studies of MDD, 0.7% (12 patients) were 65 years of age or older and 0.2% (3 patients) were 75 years or older
Geriatric patients (65 to 81 years of age) had higher EXXUA AUC and C max values than younger adult (18 to 40 years of age) patients

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