OLANZAPINE/ SAMIDORPHAN TAB
Clinical Criteria Summary
Indications
- Schizophrenia in adults
- Bipolar I disorder in adults (acute treatment of manic or mixed episodes as monotherapy and adjunct to lithium or valproate; maintenance monotherapy treatment)
Patient Selection & Clinical Guidance
- Indicated for patients where olanzapine is indicated based on individual patient characteristics who are at high risk for weight gain
- Not recommended for switching from another antipsychotic to prevent further weight gain or promote weight loss
- Requires assessment and screening for opioid use prior to initiation
- Recommended that patients have a patient identifier/medical alert identifier with them
Dosing & Administration Limits
- Available tablet strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg
- Maximum dose of olanzapine available in the combination tablet is 20 mg; no guidance provided for patients requiring more than 20 mg of olanzapine
Contraindications
- Patients currently using opioids
- Patients undergoing acute opioid withdrawal
- Refer to lithium or valproate prescribing information for contraindications if used concomitantly
Warnings & Precautions
- Increased mortality and cerebrovascular adverse reactions in elderly patients with dementia-related psychosis
- Precipitation of opioid withdrawal in opioid-dependent patients
- Vulnerability to life-threatening opioid overdose due to potential increased sensitivity to opioids and attempts to overcome samidorphan’s receptor blockade
- Neuroleptic malignant syndrome, DRESS, metabolic changes, tardive dyskinesia, orthostatic hypotension and syncope, falls, leukopenia/neutropenia/agranulocytosis, seizures, potential for cognitive and motor impairment, anticholinergic effects, hyperprolactinemia
- Most common adverse effects (>5% of patients): weight gain, somnolence, dry mouth, headache, increased appetite
Special Populations & Interactions
- Renal Impairment: Not recommended for use in end-stage renal disease (eGFR <15 ml/min/1.73 m2)
- Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third-trimester exposure; pregnancy exposure registry available
- Opioid-Free Interval Requirement: 7 days for short-acting opioids and 14 days for long-acting opioids required before initiation
- Drug Interactions: Avoid use with strong CYP3A4 inducers; avoid use with levodopa and dopamine agonists
- Pharmacokinetic properties of samidorphan are not affected by smoking status or sex