LYBALVI 10 mg/1
olanzapine and samidorphan L-malate · TABLET, FILM COATED · Alkermes, Inc.
LYBALVI is a tablet, film coated containing olanzapine and samidorphan l-malate at 10 mg/1, taken oral. Manufactured by Alkermes, Inc..
Key Facts
- Brand Name
- LYBALVI
- Generic Name
- olanzapine and samidorphan L-malate
- NDC Code (Product)
65757-652- Manufacturer
- Alkermes, Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA213378
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 09/20/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in adults ( 1 ) Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Recommended Starting Dose (olanzapine/samidorphan) Recommended Dose (olanzapine/samidorphan) Schizophrenia ( 2.2 ) 5 mg/10 mg or 10 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg Bipolar I disorder (manic or mixed episodes) ( 2.3 ) 10 mg/10 mg or 15 mg/10 mg 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg Bipolar I disorder adjunct to lithium or valproate ( 2.3 ) 10 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg See the full prescribing information for the recommended titration and maximum recommended dosage. ( 2.2 , 2.3 ) Administer LYBALVI once daily with or without food. Do not divide tablets or combine strengths. ( 2.4 ) Recommended starting dosage is 5 mg/10 mg once daily in patients who have a predisposition to hypotensive reactions, have potential for slower metabolism of olanzapine, or may be more pharmacodynamically sensitive to olanzapine. ( 2.5 ) 2.1 LYBALVI Initiation In Patients Using Opioids LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal. In patients who use opioids, delay initiation of LYBALVI for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-…
Contraindications
4 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 )] . Patients using opioids. ( 4 ) Patients undergoing acute opioid withdrawal. ( 4 ) If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for those products. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inducers : Not recommended. ( 7.1 ) Strong CYP1A2 Inhibitors : Consider dosage reduction of olanzapine component of LYBALVI. ( 7.1 ) CYP1A2 Inducer : Consider dosage increase of the olanzapine component of LYBALVI. ( 7.1 ) CNS Acting Drugs : May potentiate orthostatic hypotension. ( 7.1 ) Anticholinergic Drugs: Can increase risk for severe gastrointestinal adverse reactions. ( 7.1 ) Antihypertensive Agents : Monitor blood pressure. ( 7.2 ) Levodopa and Dopamine Agonists : Not recommended. ( 7.2 ) 7.1 Effects of Other Drugs on LYBALVI Table 4 describes clinically significant drug interactions where the concomitant use of other drugs affects LYBALVI. Table 4: Effects of Other Drugs on LYBALVI Strong CYP3A4 Inducer Clinical Implication: Coadministration of LYBALVI with a strong CYP3A4 inducer decreases AUC inf of olanzapine and samidorphan [see Clinical Pharmacology ( 12.3 )], which may reduce LYBALVI efficacy. Prevention or Management: Concomitant use of LYBALVI with strong CYP3A4 inducers is not recommended. Strong CYP1A2 Inhibitor Clinical Implication: Concomitant use of LYBALVI with a strong CYP1A2 inhibitor increases olanzapine AUC and C max [see…
Adverse Reactions
6 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 Mo…
Frequently Asked Questions
What is LYBALVI used for?
LYBALVI contains olanzapine and samidorphan L-malate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is LYBALVI a controlled substance?
LYBALVI is not classified as a controlled substance by the DEA.
What is the generic name for LYBALVI?
The generic name for LYBALVI is olanzapine and samidorphan L-malate. There are no other listed brand versions of olanzapine and samidorphan L-malate.
What is the NDC code for LYBALVI 10 mg/1?
The NDC (National Drug Code) for LYBALVI 10 mg/1 is 65757-652, listed by Alkermes, Inc..
Other LYBALVI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)