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New FDA Approved Drugs & Vaccines
NEUROLOGY
Exxua (gepirone) 6 Indication and Mechanism of Action: Gepirone is an extended-release oral tablet for the treatment of Major Depressive Disorder (MDD) in adults. According to the Centers for Disease Control and Prevention (CDC), MDD affects 16 million American
dose is missed, it should be taken as soon as the patient remembers if it is greater than 12 hours until the next dose. Otherwise, the missed dose should be skipped. Safety: Gepirone was well-tolerated in clinical trials. The most common reactions leading to discontinua- tion for patients taking gepirone in clinical trials were dizziness and nausea. Gepirone can cause QT pro- longation, so patients should be screened prior to use and electrolyte imbalances should be corrected. Since gepirone has serotonergic activity, it is import- ant to watch for serotonin syndrome when used in combination with other serotonergic drugs, and con- comitant use with monoamine oxidase inhibitors (MAOIs) should be avoided. Like other antidepres- sants, there is a boxed warning for suicidal thoughts and behaviors in adolescents and young adults. Gepirone should not be used in the third trimester of pregnancy and patients should avoid concomitant use with strong CYP3A4 inducers. How Supplied: Gepirone is supplied in 100-count bottles with child-resistant caps and is available in four strengths: 18.2 mg, 36.3 mg, 54.5 mg, and 72.6 mg extended-release tablets. The bottles should be stored at controlled room temperature away from high humidity and moisture. Additional Notes: The signs and symptoms of depression are different for every affected individ- ual. It is important that patients self-monitor their mood to determine if changes to their treatment plan are warranted. Patients can be advised to use a symptom tracking tool, such as a symptom diary, to aid with self-monitoring. Leqembi (lecanemab-irmb) Indication and Mechanism of Action: Nine of 55 new drug approvals (16%) in 2023 were designated as breakthrough therapy, 3 which is designed to expedite the development and review of drugs that are intended to treat a serious condition and prelim- inary clinical evidence indicates that the drug may
adults every year and 1 out 6 adults will get symptoms of depression in their lifetime. 7 8 The anti- depressant effects of gepirone are not well-known; however, it is thought to involve the modulation of serotonergic activity in the central nervous system (CNS) through selective agonist activity at 5HT1A receptors. The FDA’s approval is based on two clin- ical studies that showed a decrease in the change from baseline in the Hamilton Depression Rating Scale versus placebo. Administration: Gepirone should be taken by mouth with food at approximately the same time each day. Systemic exposure was higher after food and is dependent on the fat content. Since the tab- lets are an extended-release formulation, patients should be counseled to swallow the tablets whole; do not crush, split, or chew. The recommended starting dose of gepirone is 18.2 mg once daily. Based on clinical response and tolerability, the dose may be increased to 36.3 mg once daily on Day 4, and further titrated to 54.5 mg once daily after Day 7. A final titration up to 72.6 mg once daily may be used after an additional week. The maximum recommended daily dose is 72.6 mg once daily. Patients should be counseled to not stop taking gepirone without consulting their prescriber. If a
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