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Scenesse Side Effects

Generic name: afamelanotide

Note: This document contains side effect information about afamelanotide. Some of the dosage forms listed on this page may not apply to the brand name Scenesse.

Applies to afamelanotide: subcutaneous implant

General

The more commonly reported adverse effects have included implant site reaction, specifically implant site discoloration, nausea, oropharyngeal pain, cough, and fatigue.[Ref]

Dermatologic

Very common (10% or more): Implant skin reaction (21%)

Common (1% to 10%): Skin hyperpigmentation, skin irritation, melanocytic nevus, non-acute porphyria[Ref]

Implant site reactions including implant site bruising, discoloration, erythema, hemorrhage, hypertrophy, irritation, nodule, pain, pruritus, swelling; injection site bruising and erythema; and expelled implant occurred more commonly in those receiving drug than those in the vehicle group (21% vs 10%). The most common implant site reaction reported in clinical studies was implant site discoloration (10%).

Skin hyperpigmentation included events of skin hyperpigmentation, pigmentation lip (subjects also had skin hyperpigmentation), and pigmentation disorder.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (19%)

Common (1% to 10%): Oropharyngeal pain

Other

Common (1% to 10%): Fatigue[Ref]

Respiratory

Common (1% to 10%): Cough, respiratory tract infection[Ref]

Nervous system

Common (1% to 10%): Dizziness, somnolence[Ref]

References

1. "Product Information. Scenesse (afamelanotide)." Clinuvel, Inc., West Menlo Park, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.