Version July 2025
Erythropoietic protoporphyria: SUBQ: A single implant (16 mg) inserted every 2 months.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment likely to be necessary for any degree of kidney dysfunction (minimal amounts excreted in the urine unchanged) (Ref).
Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (large molecular weight): No supplemental dose or dosage adjustment likely to be necessary (Ref).
Peritoneal dialysis: Unlikely to be significantly dialyzed (large molecular weight): No dosage adjustment likely to be necessary (Ref).
CRRT: No dosage adjustment likely to be necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment likely to be necessary (Ref).
The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST; Jeong Park, PharmD, MS, BCXTP, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.
Liver impairment prior to treatment initiation:
Initial or dose adjustment in patients with preexisting liver cirrhosis:
Child-Turcotte-Pugh class A to C: No dosage adjustment necessary (Ref).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Gastrointestinal: Nausea (19%)
Local: Application-site reaction (21%)
1% to 10%:
Dermatologic: Melanocytic nevus (4%), skin hyperpigmentation (4%), skin irritation (2%)
Endocrine & metabolic: Porphyria (non-acute: 2%)
Local: Local skin discoloration (implant site: 10%)
Nervous system: Dizziness (4%), drowsiness (2%), fatigue (6%)
Respiratory: Cough (6%), oropharyngeal pain (7%), respiratory tract infection (4%)
Postmarketing: Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema)
History of severe hypersensitivity to afamelanotide or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious hypersensitivity (eg, anaphylaxis) has been reported. Remove implant and initiate appropriate therapy if hypersensitivity occurs; do not reinitiate therapy.
• Skin pigmentation: Increased skin pigmentation and darkening of preexisting nevi and ephelides may occur; full body skin examination (twice yearly) is recommended.
Other warnings/precautions:
• Phototoxic reactions: Maintain sun and light protection measures during treatment to prevent phototoxic reactions related to erythropoietic protoporphyria.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Subcutaneous [preservative free]:
Scenesse: 16 mg (1 ea)
No
Implant (Scenesse Subcutaneous)
16 mg (per each): $60,491.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SUBQ: Allow implant to reach room temperature. Insert implant 3 to 4 cm above the anterior supra-iliac crest; refer to manufacturer's labeling for full insertion details. Apply dressing to insertion site and leave in place for 24 hours. Monitor patient for 30 minutes after insertion. Implant should only be inserted by a trained health care professional. If removal of the implant is clinically necessary, refer to manufacturer's labeling for full removal details.
Erythropoietic protoporphyria: To increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria.
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies.
It is not known if afamelanotide is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Full body skin examination (twice yearly).
Afamelanotide is a melanocortin receptor agonist that binds predominantly to MC1-R; increases production of eumelanin in the skin independently of exposure to sunlight or artificial UV light sources.
Absorption: Low serum concentrations observed after SUBQ administration; no detectable serum levels observed at 9.5 hours (Minder 2017).
Metabolism: Degraded extensively intracellularly either by endocytosis following receptor binding or by unspecific proteases in the serum (Minder 2017).
Half-life elimination: ~15 hours.
Time to peak: 36 hours.
Excretion: Minimal amounts of unchanged drug recovered in the urine (Minder 2017).
