Lybalvi® is a combination of olanzapine, a second-generation (atypical) antipsychotic, and samidorphan, which is an opioid antagonist.
On this page, we present some basic information about this medication. Other articles on this website with more advanced information and tips related to this medication are linked to under Related Pages below.
FDA-approved indications
It is approved in adults for the treatment of:
1) Schizophrenia
2) Bipolar I disorder
- As monotherapy and as an adjunct to lithium or valproate for acute treatment of manic or mixed episodes
- Monotherapy maintenance treatment
Mechanism of Action/Pharmacodynamics
Antipsychotic effects of olanzapine may be mediated via a combination of dopamine and serotonin type 2 (5HT2) antagonism.
Samidorphan may exert its pharmacological effects by acting as an antagonist at the mu-opioid receptors and as a partial agonist at kappa and delta opioid receptors.
Pharmacokinetics
Steady-state concentration is reached 7 days after starting the treatment with Lybalvi®.
Contraindications
- Patients using opioids
- Patients undergoing acute opioid withdrawal
Warnings and Precautions
- Lybalvi® is associated with increased cerebrovascular adverse reactions in elderly patients with dementia-related psychosis.
- It may precipitate opioid withdrawal in opioid-dependent patients. Before starting treatment with Lybalvi®, opioid-free interval of 7 days with short-acting and 14 days with long-acting opioid should be observed.
- It may predispose patients to life-threatening opioid overdose:
– if there are attempts to overcome opioid blockade with Lybalvi®
– if opioids are resumed in patients with chronic history of opioid use prior to Lybalvi® treatment and Lybalvi® treatment is interrupted or discontinued. - Neuroleptic malignant syndrome may develop in some patients which requires immediate discontinuation of treatment and close monitoring
- Monitor for metabolic changes: hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain
- If Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected, treatment should be discontinued.
- In some patients, tardive dyskinesia may develop which requires discontinuation of Lybalvi®.
- Miscellaneous: Orthostatic hypotension, leukopenia, seizures, anticholinergic effects, and hyperprolactinemia may develop. Caution should be observed and monitoring of symptoms, and discontinuation of treatment is recommended if clinically appropriate.
Dosage
1. Schizophrenia
Starting: 5 mg/10 mg or 10 mg/10 mg orally
Recommended: 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg
May adjust dosage in weekly intervals of 5 mg (based on olanzapine component) up to the maximum dosage of 20 mg/10 mg depending on clinical response and tolerability
2. Bipolar I Disorder (manic or mixed episodes)
Starting: 10 mg/10 mg or 15 mg/10 mg orally
Recommended: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg
3. Bipolar I Disorder (adjunct to lithium or valproate)
Starting: 10 mg/10 mg orally
Recommended: 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg
May adjust dosage in weekly intervals of 5 mg (based on olanzapine component) up to the maximum dosage of 20 mg/10 mg depending on clinical response and tolerability.
Dosage forms and strengths
Oral tablets (olanzapine/samidorphan): 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg
Important! Please refer to the full Prescribing Information (see the link below) before prescribing this medication.
Related Pages
Olanzapine and samidorphan (Lybalvi®): Basic information
Samidorphan versus naltrexone: What’s the difference?
References
Prescribing information for olanzapine and samidorphan (Lybalvi®)
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