LYBALVI

OLANZAPINE AND SAMIDORPHAN L-MALATE

Manufacturer: Alkermes, Inc.

Score: 144.0

Quick Summary

LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, used for the treatment of schizophrenia and bipolar I disorder in adults. It is available in various strengths and should be administered orally once daily with or without food. The recommended dosage varies depending on the condition being treated, and dose adjustments may be necessary. LYBALVI has several important safety considerations, including a boxed warning for increased mortality in elderly patients with dementia-related psychosis, and contraindications for patients using opioids or undergoing acute opioid withdrawal. Common adverse reactions include weight increased, somnolence, dry mouth, and headache.

Key Clinical Findings and Indications

Treatment of schizophrenia in adults
Treatment of bipolar I disorder in adults
Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
Maintenance monotherapy treatment

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

Patients using opioids
Patients undergoing acute opioid withdrawal

Adverse Reactions

Weight increased
Somnolence
Dry mouth
Headache

Dosing Recommendations

General Guidance

Dosage adjustments may be necessary based on clinical response and tolerability

Schizophrenia

Adult Dose

5 mg/10 mg or 10 mg/10 mg once daily, with a recommended dosage of 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

Pediatric Dose

Bipolar I disorder (manic or mixed episodes)

Adult Dose

10 mg/10 mg or 15 mg/10 mg once daily, with a recommended dosage of 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

Pediatric Dose

Special Population Considerations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including LYBALVI, during pregnancy

Nursing Mothers

Pediatric Use

The safety and effectiveness of LYBALVI have not been established in pediatric patients

Geriatric Use

Clinical studies of LYBALVI did not include sufficient numbers of patients 65 years of age and older to determine whether they responded differently than younger adult patients
Consider a lower dosage of the olanzapine component of LYBALVI in geriatric patients who may have decreased clearance or an exaggerated pharmacodynamic response to olanzapine

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Macleods Pharmaceuticals Limited

LYBALVI

Quick Summary

Key Clinical Findings and Indications

Important Safety Information

Warning

Contraindications

Adverse Reactions

Dosing Recommendations

General Guidance

Schizophrenia

Adult Dose

Pediatric Dose

Bipolar I disorder (manic or mixed episodes)

Adult Dose

Pediatric Dose

Special Population Considerations

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

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