Pharmacy Prior Authorization Criteria

Adasuve (loxapine)

Indications for Prior Authorization

Adasuve (loxapine)

• For diagnosis of Agitation
  Indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

  Limitations of Use:

  As part of the Adasuve REMS Program to mitigate the risk of bronchospasm, Adasuve must be administered only in a certified healthcare setting.

Criteria

Adasuve

Prior Authorization

Length of Approval: 1 Time [A]

• One of the following diagnoses:
• Bipolar I disorder
• Schizophrenia
AND
• For the treatment of acute agitation
AND
• Patient does not have a history of lung disease associated with bronchospasm [e.g., asthma, chronic obstructive pulmonary disease (COPD)]

P & T Revisions

2025-03-06, 2024-03-14, 2023-02-03, 2022-03-01, 2021-03-02, 2020-02-07

References

1. Adasuve Prescribing Information. Galen US, Inc.; Souderton, PA. January 2022.

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End Notes

1. Because clinical trials in patients with asthma or COPD demonstrated that the degree of bronchospasm, as indicated by changes in forced expiratory volume in 1 second (FEV1), was greater following a second dose of Adasuve, limit Adasuve use to a single dose within a 24 hour period.

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Revision History

• 2025-03-06: 2025 Annual Review - no criteria changes
• 2024-03-14: 2024 Annual Review - no criteria changes
• 2023-02-03: 2023 Annual Review - no criteria changes
• 2022-03-01: 2022 Annual Review- Background updates
• 2021-03-02: Annual review - Background updates
• 2020-02-07: Annual review. No Changes.

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