Medical Editor: John P. Cunha, DO, FACOEP
Scenesse (afamelanotide) Implant is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Common side effects of Scenesse include:
- implant site reactions (bruising, discoloration, redness, bleeding, swelling, irritation, nodule, pain, itching),
- mouth pain/sore throat,
- darkened skin (hyperpigmentation),
- melanocytic nevus ,
- respiratory tract infection,
- non-acute porphyria, and
- skin irritation
The dose of Scenesse is insertion of a single implant, containing 16 mg of afamelanotide, using an SFM Implantation Cannula or other implantation devices that have been determined by the manufacturer to be suitable for implantation. Scenesse may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Scenesse; it is unknown how it would affect a fetus. It is unknown if Scenesse passes into breast milk. Consult your doctor before breastfeeding.
Our Scenesse (afamelanotide) Implant, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SCENESSE was evaluated in 3 randomized, multicenter, prospective, vehicle controlled clinical trials (Study CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with erythropoietic protoporphyria (EPP) without significant liver involvement. Subjects received subcutaneous SCENESSE implants containing 16 mg of afamelanotide every 2 months. A total of 125 subjects received SCENESSE and 119 subjects received vehicle implants.
Table 1 summarizes the adverse reactions that occurred in more than 2% of subjects.
Table 1: Adverse Reactions
Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039,
CUV030, and CUV029)
n (%) N = 125
n (%) N = 119
|Implant site reaction1||26 (21%)||12 (10%)|
|Nausea||24 (19%)||17 (14%)|
|Oropharyngeal pain||9 (7%)||6 (5%)|
|Cough||8 (6%)||4 (3%)|
|Fatigue||7 (6%)||3 (3%)|
|Skin hyperpigmentation2||5 (4%)||0 (0%)|
|Dizziness||5 (4%)||4 (3%)|
|Melanocytic nevus||5 (4%)||2 (2%)|
|Respiratory tract infection||5 (4%)||3 (3%)|
|Somnolence||3 (2%)||1 (1%)|
|Non-acute porphyria||2 (2%)||0 (0%)|
|Skin irritation||2 (2%)||0 (0%)|
|1 Implant site reaction includes: implant site
bruising, discoloration, erythema, hemorrhage, hypertrophy, irritation, nodule,
pain, pruritus, swelling; injection site bruising and erythema; and expelled
2 Skin hyperpigmentation includes skin hyperpigmentation, pigmentation lip (subject also had skin hyperpigmentation), and pigmentation disorder.
Specific Adverse Reactions
Implant Site Reactions
Implant site reactions were more common in the SCENESSE group (21%) compared to the vehicle group (10%). In the SCENESSE group, the most common implant site reaction was implant site discoloration (10%).
Read the entire FDA prescribing information for Scenesse (Afamelanotide Implant)