Lybalvi (Olanzapine and Samidorphan)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Lybalvi (Olanzapine and Samidorphan) is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist that is FDA approved for the treatment of schizophrenia and certain aspects of bipolar I disorder. There is a Black Box Warning for this drug as shown here. Common adverse reactions include 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)..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lybalvi (Olanzapine and Samidorphan) in pediatric patients.
Non–Guideline-Supported Use
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
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See full prescribing information for complete Boxed Warning.
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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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lybalvi (Olanzapine and Samidorphan) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lybalvi (Olanzapine and Samidorphan) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lybalvi (Olanzapine and Samidorphan) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) in geriatric settings.
Gender
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lybalvi (Olanzapine and Samidorphan) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lybalvi (Olanzapine and Samidorphan) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Administration in the drug label.
Monitoring
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lybalvi (Olanzapine and Samidorphan) and IV administrations.
Overdosage
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Mechanism of Action in the drug label.
Structure
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) How Supplied in the drug label.
Storage
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lybalvi (Olanzapine and Samidorphan) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lybalvi (Olanzapine and Samidorphan) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.