Exxua

Pronunciation: EKS-shoo-uh
Generic name: gepirone
Dosage form: extended-release tablets (18.2 mg, 36.3 mg, 54.5 mg, 72.6 mg)
Drug class: Miscellaneous antidepressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 26, 2023.

What is Exxua?

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.

Side Effects

Common Exxua side effects

The most common side effects of  Exxua that happen in more than 5% of patients and at least twice the rate of placebo patients in clinical trials were:

• dizziness 
• nausea 
• insomnia 
• abdominal pain
• Indigestion

Serious Exxua side effects

Exxua can cause serious side effects, including:

Increased risk of suicidal thoughts and actions. Exxua and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, this is more likely within the first few months of treatment or when the dose is changed. This medicine is only to be used in adults, it is not to be used in children.

Electrical changes in your heart (QT prolongation). This medicine can cause irregular heartbeats that can be life-threatening or lead to death. Your healthcare provider will check the electrical activity of your heart and will also do blood tests to check your levels of body salts (electrolytes) before and during treatment with this medicine. This is especially important if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or if you take a medicine that can prolong the QT interval of your heartbeat. Tell your healthcare provider right away if you have symptoms of an irregular heartbeat or feel dizzy, lightheaded, or faint while being treated with Exxua.

Serotonin syndrome is a potentially life-threatening problem that can happen when you take Exxua, with an increased risk when taken with certain other mediciations. Seek medical attention right away if you have symptoms of serotonin syndrome, such as agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Manic episodes may happen in people with bipolar disorder who take this medicine. Call your healthcare provider at once if you have symptoms of greatly increased energy, severe problems sleeping, racing thoughts, reckless behavior, unusually grand ideas, being more talkative than usual, excessive happiness, or excessive irritability.

These are not all the possible side effects of Exxua and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Related/similar drugs

Who should not take this medicine?

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. 

How should I take Exxua?

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.

Dosing information

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.

What happens if I miss a dose?

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.

What happens if I overdose?

 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.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and medicines, vitamins, and herbal supplements. 

Exxua and other medicines may affect each other, causing possible serious side effects. This can be Exxua affecting the way other medicines work, and other medicines may affect the way Exxua works. 

It is especially important to tell your healthcare provider if you take 

• diuretics, 
• corticosteroids, 
• medicines used to treat migraine headaches called triptans, 
• medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants. 

Your healthcare provider can tell you if it is safe to take Exxua with your other medicines. Do not start or stop any other medicines during treatment with Exxua without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. 

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Protect from high humidity and moisture.

Ingredients

Active ingredient: gepirone.

Inactive ingredients: colloidal silicon dioxide, Hypromellose, iron oxide (red and/or yellow as coloring agents), magnesium stearate, and microcrystalline cellulose. 

Manufacturer

Mission Pharmacal Company, San Antonio, TX 78230 1355.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer