Approved by at least one major regulator for a defined indication, with published human pharmacokinetics and a prescribing label. Well-characterised does not mean risk-free, read the label warnings.
Elimination half-life ~5 days (~120 h). Tmax at steady state median 48 h (range 24-72 h). MW ~63 kDa is the label's approximate value for the Fc-fusion protein, not a PubChem exact mass.
Model a dosing schedule →0.75 mg start, up to 4.5 mg once weekly.
FDA prescribing information (DailyMed) and REWIND/AWARD phase 3 program; high quality.
Lyophilised: Not applicable, supplied as a pre-filled solution pen/syringe (not lyophilized).
Reconstituted: Refrigerate 2-8°C; pre-filled solution, no reconstitution. Protect from light.
BOXED WARNING: Risk of thyroid C-cell tumors. Contraindicated in patients with personal/family history of MTC or MEN 2. Also: pancreatitis, hypoglycemia with insulin/secretagogues, hypersensitivity, diabetic retinopathy, acute kidney injury.