EXXUA Delayed release tablet Ref.[107407] Active ingredients: Gepirone

2.1 Important Recommendations Prior to Initiating and During Treatment with EXXUA

Electrocardiogram and Electrolyte Monitoring

• Correct electrolyte abnormalities prior to initiating EXXUA. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA [see Warnings and Precautions (5.2)].
• Perform an electrocardiogram (ECG) prior to initiating EXXUA, during dosage titration, and periodically during treatment.
• Do not initiate EXXUA if QTc is >450 msec at baseline.
• Monitor ECGs more frequently if EXXUA is used:
  • concomitantly with drugs known to prolong the QT interval
  • in patients who develop QTc ≥450 msec during treatment
  • in patients with a significant risk of developing torsade de pointes [see Warnings and Precautions (5.2) and Drug Interactions (7)].
• Do not escalate the EXXUA dosage if the QTcF is >450 msec [see Warnings and Precautions (5.2)].

Bipolar Disorder, Mania, and Hypomania Screening

Screen patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with EXXUA [see Warnings and Precautions (5.3)].

2.2 Important Administration Instructions

Take EXXUA orally with food at approximately the same time each day [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do not split, crush, or chew EXXUA.

2.3 Recommended Dosage

The recommended starting dosage of EXXUA is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to 36.3 mg orally once daily on Day 4 and further titrated to 54.5 mg orally once daily after Day 7 and to 72.6 mg orally once daily after an additional week. The maximum recommended daily dosage of EXXUA is 72.6 mg once daily.

2.4 Recommended Dosage in Geriatric Patients

The recommended starting dosage of EXXUA in geriatric patients is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to maximum recommended dosage of 36.3 mg orally once daily after Day 7 [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

2.5 Recommended Dosage in Patients with Renal Impairment

The recommended starting dosage of EXXUA in patients with creatinine clearance <50 mL/min is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

The recommended dosage in patients with creatinine clearance ≥50 mL/min is the same as in patients with normal renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.6 Recommended Dosage in Patients with Hepatic Impairment

The recommended starting dose of EXXUA in patients with moderate (Child-Pugh B) hepatic impairment is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

EXXUA is contraindicated in patients with severe (Child-Pugh C) hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

The recommended dosage in patients with mild (Child-Pugh A) hepatic impairment is the same as patients with normal hepatic function.

2.7 Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors

Reduce the EXXUA dose by 50% when used concomitantly with a moderate CYP3A4 inhibitor [see Drug Interactions (7)].

EXXUA is contraindicated in patients receiving strong CYP3A4 inhibitors [see Contraindications (4) and Drug Interactions (7)].

2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

At least 14 days must elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with EXXUA. Conversely, at least 14 days must be allowed after stopping EXXUA before starting an MAOI antidepressant [see Contraindications (4) and Drug Interactions (7)].