DEPEMOKIMAB-ULAA INJ,SOLN
Clinical Criteria Summary
Indication
- Add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older
Patient Population & Clinical Criteria
- Severe, uncontrolled eosinophilic asthma
- Blood eosinophils ≥ 300 cells/μL in past 12 months or ≥ 150 cells/μL at screening
- Aged 12 years and older
- Background maintenance therapy consisting of medium- to high-dose inhaled corticosteroids (ICS) plus at least one additional asthma controller
- For patients switching from prior biologic therapy: stable on and had documented clinical benefit from mepolizumab or benralizumab for ≥12 months prior to screening
Dosing & Administration
- 100 mg administered Q6 months by SC injection
- Administered by a healthcare provider in-clinic
Contraindications & Warnings/Precautions
- None
- Hypersensitivity reactions, including anaphylaxis
- Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation
- Treat pre-existing helminth infections prior to initiation
- If infection occurs during therapy and is unresponsive to anti-helminthics, pause depemokimab-ulaa until resolution
Clinical Selection & Place in Therapy
- Indicated for severe eosinophilic asthma; not first-line options for patients whose disease is primarily driven by allergic (IgE-mediated) or non-eosinophilic mechanisms
- Primary differentiator is the twice-yearly dosing schedule
- May provide an option for patients without other eosinophilic comorbidities who are routinely nonadherent to more frequently dosed biologics and who are able to make Q6-month in-clinic visits for administration by a healthcare provider