LYBALVI (olanzapine/samidorphan)

LYBALVI (olanzapine/samidorphan)

SELF-ADMINISTRATION - ORAL

FDA Approved Indications:

• Indicated for the treatment of:

  • Schizophrenia in adults

  • Acute mania or acute episodes with mixed features of bipolar I disorder (as monotherapy or in combination to lithium or valproate), and maintenance monotherapy treatment

Prior Authorization Criteria:

1. For diagnosis of schizophrenia or bipolar I disorder (acute mania and acute episodes with mixed features):

• Dose does not exceed olanzapine 20 mg/samidorphan 10 mg once daily; AND

• Inadequate response, intolerance, or contraindication to two of the following:

  • Aripiprazole

  • Olanzapine

  • Quetiapine IR/ER

  • Risperidone

  • Clozapine

  • Ziprasidone

  • Paliperidone

  • Asenapine; AND

• Provider attestation is required confirming that no opioids will be used in combination with Lybalvi

Coverage Duration

• 1 year

Dosing

1. For diagnosis of bipolar I disorder (acute mania and acute episodes with mixed features):

• Monotherapy:

  1. Initiate Lybalvi at 10 mg/10 mg or 15 mg/10 mg once daily

  2. Recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

  3. When dosage adjustments are necessary, dose increments/decrements of 5 mg (based on olanzapine component) are recommended

  4. Maximum recommended dosage is 20 mg/10 mg once daily

• Maintenance monotherapy

  1. Administer Lybalvi at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

• Adjunctive to lithium or valproate

  1. Initiate Lybalvi at 10 mg/10 mg once daily

  2. Recommended dosage is 10 mg/10 mg, 15 mg/10 mg or 20 mg/10 mg once daily

  3. When dosage adjustments are necessary, dose increments/decrements of 5 mg (based on olanzapine component) are recommended up to a maximum recommended dosage of 20 mg/10 mg once daily

2. For diagnosis of schizophrenia:

• Initiate Lybalvi at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg orally once daily. 

• The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

• Dosage may be adjusted at weekly intervals of 5 mg (based on olanzapine component) depending upon clinical response and tolerability, up to a maximum recommended dosage of 20 mg/10 mg

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Administration: Do not divide tablets or combine strengths

• Warning: Lybalvi is not approved for the treatment of patients with dementia-related psychosis

• Contraindications:

  • Patients using opioids

  • Patients undergoing acute opioid withdrawal

  • If Lybalvi is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for those products

• Drug Interactions:

  • Strong CYP3A4 Inducers: Not recommended

  • Strong CYP1A2 Inhibitors: Consider dosage reduction of olanzapine component of Lybalvi

  • CYP1A2 Inducer: Consider dosage increase of the olanzapine component of Lybalvi

  • CNS acting drugs: May potentiate orthostatic hypertension

  • Anticholinergic drugs: Can increase risk for severe gastrointestinal adverse reactions

  • Antihypertensive agents: Monitor blood pressure

  • Levodopa and dopamine agonists: Not recommended

Policy Updates

• 2/15/2022 – New policy approved by P&T committee

References

1. Lybalvi prescribing information. Alkermes, Inc. Waltham, MA. May 2021.