Olanzapine/Samidorphan

DEA Class;  Rx

Common Brand Names; Lybalvi

Patients using opioids

Patients undergoing acute opioid withdrawal

If administered with lithium or valproate, refer to lithium or valproate prescribing information for contraindications for these products

• Glucose levels increase >10 mg/dL (66%)
• Shift from hemoglobin (Hgb) A1c normal (<5.7%) to impaired (≥5.7 to < 6.5%) (42%)
• Weight increased (19-25%)
• Somnolence (21%)
• Shifts in fasting triglycerides from normal to high (14%)
• Increased appetite (11%)
• Shift from Hgb A1c impaired (≥5.7 to < 6.5%) to high (≥6.5%) (9.5%)
• Somnolence (9%)
• Dry mouth (7%)
• Waist circumference increased (6%)
• Headache (4-6%)
• Blood creatine phosphokinase increased (5%)
• Lethargy (4%)
• Sedation (2-4%)
• Dizziness (2-3%)
• Akathisia (3%)
• ALT increased (3%)
• AST increased (3%)
• Constipation (3%)
• Fatigue (3%)
• Nausea (3%)
• Blood pressure (BP) increased (3%)
• Neutrophil count decreased (2-3%)
• Blood insulin increased (2-3%)
• Weight decreased (2%)
• Dyslipidemia (2%)
• Schizophrenia (1%)
• Abnormal liver function tests (1%)

Significantly greater increase of death reported in elderly patients with dementia-related psychosis treated with olanzapine; majority of deaths were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia)

Cerebrovascular adverse reactions (eg, stroke, transient ischemic attack), including fatalities, reported in olanzapine trials in elderly patients with dementia-related psychosis

DRESS reported with exposure to olanzapine; may present with a cutaneous reaction (eg, rash, exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications (eg, hepatitis, nephritis, pneumonitis, myocarditis, pericarditis); discontinue treatment if DRESS is suspected

Antipsychotics may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, fractures, or other injuries; complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

Olanzapine was associated with constipation, dry mouth, and tachycardia, and all adverse reactions related to cholinergic antagonism; use with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, or a history of paralytic ileus or related condition

Atypical antipsychotics may disrupt the ability to reduce core body temperature; strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use with caution in patients who may experience these conditions

May cause somnolence and has the potential to impair judgment, thinking, or motor skills; advise patients to exercise caution when operating hazardous machinery, including motor vehicles

No data are available on use of samidorphan or olanzapine/samidorphan in pregnant females to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Lactation

Olanzapine

• Present in human milk

• There are reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk

• There is no information on the effects of olanzapine on milk production

Samidorphan

• There are no data on the presence of samidorphan or olanzapine/samidorphan in human milk, effects on breastfed infants, or effects on milk production

• When administered to lactating rats, samidorphan and a metabolite were detected in the plasma of nursing pups, likely due to the presence of samidorphan in milk

• Monitor infants exposed to olanzapine/samidorphan for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements)