LYBALVI Initiation In Patients Using Opioids

LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal.

In patients who use opioids, delay initiation of LYBALVI for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids [see Warnings and Precautions (5.3)].

Recommended Dosage in Schizophrenia

Initiate LYBALVI at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (contains 10 mg of olanzapine and 10 mg of samidorphan) orally once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (contains 15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (contains 20 mg of olanzapine and 10 mg of samidorphan) once daily.

Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component of LYBALVI) depending upon clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once daily.

Recommended Dosage in Bipolar I Disorder (Manic or Mixed Episodes)

Administration Information

Administer LYBALVI orally once daily with or without food as a single tablet.

Do not divide tablets or combine strengths.

Dosage Recommendations in Specific Populations

The recommended starting dosage of LYBALVI is 5 mg/10 mg once daily in patients who have a higher risk of hypotensive reactions, are at risk of slower olanzapine metabolism, or may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.9), Drug Interactions (7.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)]. If dose escalation is necessary, increase the dosage slowly in these patients.