Active Ingredient: Cemiplimab
Cemiplimab as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 350 milligrams cemiplimab, once every 3 weeks.
Patients with NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test.
The recommended dose is 350 mg cemiplimab every 3 weeks (Q3W) administered as an intravenous infusion over 30 minutes.
Treatment may be continued until disease progression or unacceptable toxicity.
No dose adjustment is recommended for elderly patients. Cemiplimab exposure is similar across all age groups. Data are limited in patients ≥75 years on cemiplimab monotherapy.
Cemiplimab is administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Other medicinal products should not be co-administered through the same infusion line.
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