Samidorphan L-Malate (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- LYBALVI
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
Indications and Usage
LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment
Contraindications
LYBALVI is contraindicated in patients: who are using opioids [see Warnings and Precautions ( 5.3 , 5.4), Drug Interactions ( 7.3)]. who are undergoing acute opioid withdrawal [see Warnings and Precautions (5.3, 5.4), Drug Interactions (7.3)]. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products [see Warnings and Precautions (5.18)].
Adverse Reactions
The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-related Psychosis [see Boxed Warning, Warnings and Precautions (5.1)] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2)] Precipitation of Opioid Withdrawal in Patients Who Are Dependent on Opioids [see Warnings and Precautions (5.3)] Vulnerability to Life-Threatening Opioid Overdose [see Warnings and Precautions (5.4)] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.5)] Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.6)] Metabolic Changes [see Warnings and Precautions (5.7)] Tardive Dyskinesia [see Warnings and Precautions (5.8)] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.9)] Falls [see Warnings and Precautions (5.10)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.11)] Dysphagia [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.14)] Body Temperature Regulation [see Warnings and Precautions (5.15)] Anticholinergic (Antimuscarinic) Effects [see Warnings and Precautions (5.16)] Hyperprolactinemia [see Warnings and Precautions (5.17)] Risks Associated with Combination Treatment with Lithium or Valproate [see Warnings and Precautions (5.18)]
Mechanism of Action
The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.