Exxua (gepirone) is an antidepressant used to treat major depressive disorder (MDD) in adults. Exxua is thought to work on serotonin levels in the brain, serotonin is a neurotransmitter. Exxua's mechanism of action (MOA) is thought to be by activating serotonin receptors called  5HT1A receptors as Exxua is a selective partial agonist of the 5-HT_1A receptor.

Exxua became an FDA-approved medicine on September 22, 2023, to treat major depressive disorder in adults.  During the development of gepirone, it was given the brand name Travivo which was then later changed to Exxua.

Exxua has been approved as extended-release tablets in 18.2 mg, 36.3 mg, 54.5 mg, and 72.6 mg strengths.

Take Exxua exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking this medicine without first talking to your healthcare provider. 

Exxua is usually taken one time each day at about the same time each day, taken with food.

Exxua tablets should be swallowed whole, do not break, chew, crush, or dissolve tablets.

Usual Adult Dose for Major Depressive Disorder

Initial dose: 18.2 mg orally once a day, at approximately the same time each, and taken with food. Tablets should be swallowed whole, do not break, chew, crush, or dissolve tablets.

Increasing dose: Depending on clinical response and tolerability, the dosage may be increased to 36.3 mg once daily on Day 4. The dosage may be further increased to 54.5 mg once daily after Day 7 and to 72.6 mg once daily after an additional week.

Geriatric patients: The recommended starting dosage is 18.2 mg once daily. The dosage may be increased to 36.3 mg after 7 days.

Patients with Renal Impairment (creatinine clearance < 50 mL/min): Recommended starting dosage is 18.2 mg once daily. The dosage may be increased to 36.3 mg once daily after 7 days.

Moderate Hepatic Impairment (Child Pugh B):  The dosage may be increased to 36.3 mg once daily after 7 days.

When used with moderate CYP3A4 inhibitors: Adjust Exxua dose by 50%.

Exxua extended release tablet strengths: 18.2 mg, 36.3 mg, 54.5 mg, and 72.6 mg.

Exxua should not be taken if you: 

• have an allergy or are hypersensitive to the active ingredient gepirone, or any of the inactive ingredients.
• have congenital long QT syndrome or a prolonged QTc interval greater than 450 msec at baseline.
• have severe liver impairment.
• are taking another medicine that is a strong CYP3A4 inhibitor.
• are taking an MAOI (Monoamine oxidase inhibitors) or within 14 days of stopping treatment with Exxua. Do not start taking Exxua within 14 days of discontinuing an MAOI.

Before taking this medicine

Before taking Exxua, tell your healthcare provider about all your medical conditions, including if you: 

• have, or you have a family history of bipolar disorder, mania, or hypomania 

• have any heart problems, including heart failure, recent heart attack, high blood pressure, a slow heart rate, or heart rhythm problems 

• have a history of electrolyte problems, including low potassium or low magnesium 

• have liver problems 

• have kidney problems.

Pregnancy 

Tell your healthcare provider if you are pregnant or plan to become pregnant. Exxua may harm your unborn baby. Taking this medicine in the last 3 months of pregnancy may cause the baby to have withdrawal symptoms or breathing problems, temperature control issues, feeding issues, or other problems after birth. Talk to your healthcare provider about the risks to the baby if you take Exxua during pregnancy.

If you become pregnant or think you may be pregnant while taking Exxua tell your healthcare provider immediately. There is a pregnancy registry for females who take this medicine during pregnancy. The purpose of the registry is to collect information about the health of mothers and babies exposed to Exxua during pregnancy. If you become pregnant during treatment with this medicine, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan or breastfeed. It is not known if Exxua passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

 If you do breastfeed during treatment with Exxua, it is important to call your healthcare provider if the baby develops sleepiness or fussiness or is not feeding or gaining weight well. 

If you miss a dose, take it as soon as you remember. If it is time for your next dose, skip the missed dose and take only your regularly scheduled dose Do not take 2 doses at the same time to make up for a missed dose.

 If you take too much Exxua, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.