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.
IMPORTANT, two valid and very different figures depending on formulation. The 15 h half-life (median tmax 36 h) is from the FDA label for the controlled-release bioresorbable IMPLANT. An older human study of INJECTED free peptide reported a far shorter subcutaneous beta-phase half-life of 0.8-1.7 h. Route and formulation drive the difference; applying the implant figure to injected peptide would mislead badly.
Model a dosing schedule →Single fixed approved dose: one 16 mg implant inserted subcutaneously via cannula. Not a titrated range. Must be administered by a trained healthcare professional.
Lyophilised: Supplied as a solid bioresorbable implant, not a powder. Refrigerate 2-8°C, protect from light.
No boxed warning. Contraindicated in known hypersensitivity. Serious hypersensitivity reactions including anaphylaxis have been reported post-marketing. May cause generalised increased skin pigmentation and darkening of pre-existing naevi, a full-body skin examination twice yearly is recommended. Most common adverse reactions: implant-site reaction (21%), nausea (19%), oropharyngeal pain (7%), cough (6%), fatigue (6%), skin hyperpigmentation (4%).