From the FDA Drug Label
The recommended starting dosage is one 50 mg/20 mg capsule (contains 50 mg of xanomeline and 20 mg of trospium chloride) orally twice daily for at least two days Increase the dosage to one 100 mg/20 mg capsule (contains 100 mg of xanomeline and 20 mg of trospium chloride) orally twice daily for at least five days. The dosage may be increased to one 125 mg/30 mg capsule (contains 125 mg of xanomeline and 30 mg of trospium chloride) orally twice daily based on patient tolerability and response Maximum recommended dosage is 125 mg/30 mg orally twice daily.
The starting dose of Cobenfy (Xanomeline-Trospium Chloride) for schizophrenia is 50 mg/20 mg orally twice daily for at least two days. The dose should be increased to 100 mg/20 mg orally twice daily for at least five days, and may be further increased to 125 mg/30 mg orally twice daily based on patient tolerability and response. The maximum recommended dosage is 125 mg/30 mg orally twice daily 1.
From the Research
The starting dose of Cobenfy (Xanomeline-Trospium Chloride) for schizophrenia is 10 mg/20 mg (xanomeline/trospium chloride) twice daily, with a recommended therapeutic dose of 30 mg/60 mg twice daily, as supported by the most recent and highest quality study 2.
Key Considerations for Dosing
- The dose should be increased weekly in increments of 10 mg/20 mg twice daily, as tolerated, to minimize side effects, particularly anticholinergic effects like dry mouth, constipation, and urinary retention.
- Patients should take Cobenfy with food to improve tolerability.
- During dose adjustments, monitor patients closely for adverse effects, particularly cardiovascular effects and anticholinergic symptoms.
- If intolerable side effects occur, consider temporarily reducing the dose before attempting to increase it again.
Mechanism of Action
- Cobenfy works through a dual mechanism - xanomeline acts as a muscarinic receptor agonist targeting M1/M4 receptors in the brain, while trospium chloride limits peripheral cholinergic effects, improving the overall tolerability profile of the medication.
Efficacy and Safety
- Studies have shown that xanomeline-trospium chloride is effective in reducing symptoms of psychosis and is generally well tolerated in people with schizophrenia, with a favorable safety profile compared to traditional antipsychotics 3, 2, 4.
- Common adverse events include nausea, dyspepsia, vomiting, and constipation, but the medication is not significantly associated with weight gain or extrapyramidal symptoms.
Maximum Recommended Daily Dose
- The maximum recommended daily dose is 60 mg/120 mg (administered as 30 mg/60 mg twice daily).
Monitoring and Titration
- Monitor patients closely for adverse effects, particularly cardiovascular effects and anticholinergic symptoms, during dose adjustments.
- Titrate the dose gradually to minimize side effects and improve tolerability.