Class: Immune checkpoint inhibitor – PD-L1 monoclonal antibody (IgG1κ)
Mechanism:
- Binds PD-L1, blocking its interaction with PD-1 and CD80
- Restores T-cell–mediated immune response against tumor cells
- Does not bind PD-L2, allowing some preservation of immune homeostasis compared to PD-1 blockade
Key Oncology Indications
- Unresectable stage III NSCLC after concurrent chemoradiotherapy (PACIFIC regimen)
- Extensive-stage SCLC in combination with platinum + etoposide (CASPIAN regimen)
- Other regional approvals: urothelial carcinoma, biliary tract cancer (with gemcitabine/cisplatin)
Typical Adult Dosing
- NSCLC consolidation: 10 mg/kg IV q2 weeks OR 1500 mg IV q4 weeks
- ES-SCLC: 1500 mg IV Day 1 of each 21-day cycle × 4 cycles (with chemo), then 1500 mg IV q4 weeks as maintenance
- Infuse over 60 minutes; no premedication unless prior infusion reaction
Toxicity Profile & Pharmacist Monitoring
| Toxicity Type | Examples | Monitoring / Prevention |
|---|---|---|
| Immune-mediated (can affect any organ) | Pneumonitis, hepatitis, colitis, thyroiditis, hypophysitis, adrenal insufficiency, nephritis | Baseline & periodic LFTs, TFTs, cortisol, renal function; educate on cough, diarrhea, rash, fatigue |
| Infusion-related | Fever, chills, rigors, rash | Monitor during infusion; treat with interruption, supportive meds |
| Endocrine | Hypo/hyperthyroidism, adrenal insufficiency | Monitor TSH, free T4, cortisol |
| Dermatologic | Rash, pruritus | Symptomatic management, topical steroids if mild |
Pharmacist Pearls
- Onset of immune toxicities can be delayed — monitor even months after stopping
- For Grade ≥2 immune toxicities: withhold drug and start corticosteroids (prednisone 1–2 mg/kg/day); taper over ≥4 weeks
- No routine premeds unless prior reaction
- Avoid systemic steroids before starting unless clinically indicated (may blunt efficacy)
- Educate patients to report new respiratory, GI, endocrine, or skin symptoms promptly