Lybalvi (Olanzapine and Samidorphan)

{{DrugProjectFormSinglePage |authorTag=Tejasvi Aryaputra |genericName=Lybalvi |aOrAn=a |drugClass=combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist |indicationType=treatment |indication=schizophrenia and certain aspects of bipolar I disorder |hasBlackBoxWarning=Yes |adverseReactions=somnolence, headache, [[dry mouth], and weight increase for patients with schizophrenia. Dizziness, asthenia, constipation, tremor, dry mouth, somnolence, and increase appetite for patients with Bipolar I Disorder, Manic or Mixed Episodes (Olanzapine). Weight gain, back pain, constipation, increased salivation, dry mouth, paresthesia, dyspepsia, increased appetite, and speech disorder for patients with Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (Olanzapine). |blackBoxWarningTitle=TITLE |blackBoxWarningBody=Condition Name: (Content) |fdaLIADAdult=Recommended Dosage in Schizophrenia

• Start Lybalvi orally, once daily 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).
• Recommended dosage of Lybalvi is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.
• 5 mg is how much the dosage can be adjusted at weekly intervals.

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

• Start Lybalvi once daily at either 10 mg/10 mg or 15 mg/10 mg.
• Recommended dosage of Lybalvi is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.
• 5 mg is how much the dosage can be adjusted up or down at intervals of not less than 24 hours.

Maintenance Monotherapy:

• Recommended dosage of Lybalvi is 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.

Adjunctive to lithium or valproate:

• Start Lybalvi orally, once daily at 10 mg/10 mg.
• Recommended dosage of Lybalvi is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.
• 5 mg is how much the dosage can be adjusted at weekly intervals.

|offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in adult patients. |offLabelAdultNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in adult patients. |offLabelPedGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in pediatric patients. |offLabelPedNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in pediatric patients. |contraindications=*Lybalvi is contraindicated when patients are using opioids.

• Lybalvi is contraindicated when patients are undergoing acute opioid withdrawal.

|warnings=Increased Mortality in Elderly Patients with Dementia-Related Psychosis

• Patients at an increased risk of death include elderly patients who are treated with antipsychotic drugs for their dementia-related psychosis.
• 3.5% was the incidence of death in patients treated with olanzapine who are part of the placebo-controlled clinical trials of elderly patients with dementia-related psychosis.
• 1.5% was the incidence of death in patients treated with the placebo who are part of the placebo-controlled clinical trials of elderly patients with dementia-related psychosis.

|alcohol=Alcohol-Lybalvi (Olanzapine and Samidorphan) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. }}