Exxua

Exxua

Exxua

What is Exxua?

Exxua was approved by the FDA on September 22, 2023 as a medicine for the treatment of major depressive disorder in adults. During the development of Gepiron, it was given the brand name Travivo, which was later changed to Exxua.

Exxua is approved as a prolonged-release tablet in strengths of 18.2 mg, 36.3 mg, 54.5 mg and 72.6 mg.

Side effects

Common side effects of Exxua

The most common side effects of Exxua, occurring in more than 5% of patients in clinical trials and at least twice as common as in placebo patients, were:

• Schwindel
• Brechreiz
• Schlaflosigkeit
• Bauchschmerzen
• Verdauungsstörungen

Serious side effects of Exxua

Exxua can cause serious side effects including:

Increased risk of suicidal thoughts and actions.Exxua and other antidepressants can cause suicidal thoughts and actions in some people age 24 and younger. This is more likely in the first few months of treatment or when the dose is changed. This medicine should only be used in adults and should not be used in children.

Electrical changes in your heart (QT prolongation). This medicine can cause irregular heartbeats, which can be life-threatening or cause death. Your doctor will check your heart's electrical activity and also do blood tests to check your body salts (electrolytes) levels 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 are taking a medicine that may prolong the QT interval of your heartbeat. Tell your doctor immediately if you have symptoms of an irregular heartbeat or experience dizziness, lightheadedness, or fainting during treatment with Exxua.

Serotonin syndromeis a potentially life-threatening problem that can occur when taking Exxua, although the risk is increased when taken with certain other medications. Seek immediate medical attention if you have symptoms of serotonin syndrome, such as restlessness, hallucinations, fever, sweating, shaking, fast heartbeat, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Manic episodesmay occur in people with bipolar disorder who take this medicine. Call your doctor immediately if you notice symptoms such as greatly increased energy, severe difficulty sleeping, racing thoughts, reckless behavior, unusually big ideas, being more talkative than usual, excessive cheerfulness, or excessive irritability.

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

Who should not take this medicine?

Exxua should not be taken if you:

• Sie haben eine Allergie oder sind überempfindlich gegen den Wirkstoff Gepiron oder einen der inaktiven Inhaltsstoffe.
• Sie haben ein angeborenes langes QT-Syndrom oder ein verlängertes QTc-Intervall von mehr als 450 ms zu Studienbeginn.
• eine schwere Leberfunktionsstörung haben.
• Sie nehmen ein anderes Arzneimittel ein, das einen starken CYP3A4-Hemmer darstellt.
• wenn Sie einen MAOI (Monoaminoxidasehemmer) einnehmen oder innerhalb von 14 Tagen nach Beendigung der Behandlung mit Exxua. Beginnen Sie nicht innerhalb von 14 Tagen nach Absetzen eines MAOI mit der Einnahme von Exxua.

Before you take this medicine

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

• You have bipolar disorder, mania or hypomania, or have a family history of such illnesses

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

• Have had electrolyte problems in the past, including low potassium or magnesium

• Have liver problems

• Have kidney problems.

pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. Exxua can harm your unborn baby. Taking this medicine in the last three months of pregnancy may cause the baby to have withdrawal symptoms or breathing problems, temperature control problems, feeding problems, or other problems after birth. Talk to your doctor 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 doctor immediately. There is a pregnancy registry for women taking 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 while taking this medication, talk to your doctor about registering with the National Antidepressant Pregnancy Registry at 1-866-961-2388 or visit online at

Breastfeeding

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known whether Exxua passes into breast milk. Talk to your doctor about the best way to feed your baby while you are taking this medicine.

If you are breastfeeding during treatment with Exxua, it is important to call your doctor if the baby develops sleepiness or restlessness or does not feed well or gains weight.

How should I take Exxua?

Take Exxua exactly as your doctor has told you. Do not change the dose or stop taking this medicine without talking to your doctor first.

Exxua is usually taken once daily at about the same time with a meal.

Exxua tablets should be swallowed whole. The tablets must not be broken, chewed, crushed or dissolved.

Dosage information

Usual adult dosage for severe depression

Starting dose:Take 18.2 mg orally once daily, at approximately the same time, with food. The tablets should be swallowed whole. The tablets must not be broken, chewed, crushed or dissolved.

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

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

Patients with impaired kidney function(Creatinine clearance < 50 ml/min): The recommended starting dose is 18.2 mg once daily. The dosage may be increased to 36.3 mg once daily after 7 days.

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

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

Strengths of Exxua extended-release tablets: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. When it is time for your next dose, skip the missed dose and take only your regular dose. Do not take two doses at the same time to make up for a missed dose.

What happens if I overdose?

If you have taken too much Exxua, call your doctor or the Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room immediately.

Interactions

Tell your doctor about all medications you take, including prescription drugs, vitamins, and herbal supplements.

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

It is especially important to tell your doctor if you take it

• Diuretika,
• Kortikosteroide,
• Arzneimittel zur Behandlung von Migränekopfschmerzen, sogenannte Triptane,
• Arzneimittel zur Behandlung von Stimmungs-, Angst-, psychotischen oder Denkstörungen, einschließlich selektiver Serotonin-Wiederaufnahmehemmer (SSRIs), Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRIs) oder trizyklische Antidepressiva.

Your doctor can tell you whether it is safe to take Exxua with your other medicines. Do not start or stop any other medicines while taking Exxua without talking to your doctor first. Find out about the medications you are taking. Keep a list of these to show your doctor and pharmacist when you get a new medicine.

storage

Store at room temperature between 20°C and 25°C.

Protect from high humidity and moisture.

Ingredients

Active ingredient:Gepiron.

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

Manufacturer

Mission Pharmacal Company, San Antonio, TX 78230 1355.

References

1. Exxua-Produktetikett der Food and Drug Administration (FDA).

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