Lybalvi

FDA label

Read the full label on DailyMed ↗

Titration Schizophrenia & adjunct: adjust at weekly intervals (5-mg olanzapine steps). Bipolar monotherapy (acute): ≥24 h between adjustments.

Renal Not recommended in end-stage renal disease.

Hepatic No adjustment needed - exposure is higher in moderate hepatic impairment but not expected to be clinically relevant; severe hepatic impairment not studied

Opioid-free interval required before starting: ≥7 days (short-acting) / ≥14 days (long-acting opioids).

Instructions

• Once daily with or without food, as a single tablet — do not divide tablets or combine strengths
• Opioid users: delay initiation ≥7 days after last short-acting opioid, ≥14 days after last long-acting opioid
• Start 5/10 mg QD and escalate slowly if hypotension-prone, slower olanzapine metabolism, or olanzapine-sensitive

Available strengths

• tab 5/10, 10/10, 15/10, 20/10 mg

Contraindications

• Patients using opioids — samidorphan (opioid antagonist) precipitates withdrawal; blockade also invites fatal overdose from attempts to override it
• Patients undergoing acute opioid withdrawal

Cautions

• Precipitation of severe opioid withdrawal in opioid-dependent patients (may require hospitalization)
• Vulnerability to life-threatening opioid overdose: overriding the blockade with high/repeated opioid doses can be fatal, especially as blockade wanes after stopping; prior chronic users lose tolerance — emergency opioid anesthesia/analgesia requires discontinuing Lybalvi with trained monitoring
• Cerebrovascular events incl. fatal stroke in elderly dementia patients
• Neuroleptic malignant syndrome — discontinue immediately
• DRESS — discontinue if suspected
• Metabolic changes: fasting glucose and lipids at baseline and periodically; monitor weight
• Tardive dyskinesia
• Orthostatic hypotension and syncope
• Leukopenia/neutropenia/agranulocytosis — CBC monitoring if prior low WBC
• Seizures; cognitive/motor impairment; anticholinergic effects; hyperprolactinemia

Adverse reactions

• Schizophrenia: weight increased, somnolence, dry mouth, headache
• Bipolar mania (olanzapine data): somnolence, dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite, tremor
• Adjunct to lithium/valproate: dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia

Pregnancy Third-trimester exposure → neonatal EPS/withdrawal; no established olanzapine birth-defect risk; no human samidorphan data; pregnancy registry 1-866-961-2388.

Lactation Present in milk at low levels (<1% weight-adjusted maternal dose); monitor infant for sedation, irritability, poor feeding, EPS.