Exxua

Generic name: Gepirone
Dosage form: extended-release tablets (18.2 mg, 36.3 mg, 54.5 mg, 72.6 mg)

Usage of 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-HT1A 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.

Exxua 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.

Before taking Exxua

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.

How to use Exxua

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 other drugs will affect Exxua

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.

Disclaimer

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