Lybalvi (Olanzapine and Samidorphan)

Lybalvi (Olanzapine and Samidorphan)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

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

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

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.