Scenesse Generic Name & Formulations
Legal Class
Rx
General Description
Afamelanotide 16mg; per implant; for SC use.
Pharmacological Class
Melanocortin receptor agonist.
How Supplied
Implant (in vial)—1
Manufacturer
Generic Availability
NO
Scenesse Indications
Indications
To increase pain free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria.
Scenesse Dosage and Administration
Adult
See full labeling. Use an SFM implantation cannula or other suitable devices. ≥18yrs: Insert 1 implant subcutaneously above the anterior supra-iliac crest every 2 months.
Children
<18yrs: not established.
Scenesse Contraindications
Not Applicable
Scenesse Boxed Warnings
Not Applicable
Scenesse Warnings/Precautions
Warnings/Precautions
Should be administered by an experienced health care provider. Pre-existing nevi and ephelides. Monitor skin pigmentary lesions; perform full body skin exam twice yearly. Advise patients to maintain sun and light protection measures during treatment to prevent phototoxic reactions. Pregnancy. Nursing mothers.
Scenesse Pharmacokinetics
See Literature
Scenesse Interactions
Not Applicable
Scenesse Adverse Reactions
Adverse Reactions
Implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin
hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, skin irritation; skin pigmentation/darkening.
Scenesse Clinical Trials
See Literature
Scenesse Note
Not Applicable
Scenesse Patient Counseling
See Literature