Scenesse Side Effects

Generic name: afamelanotide

Medically reviewed by Drugs.com. Last updated on Sep 20, 2024.

Note: This document provides detailed information about Scenesse.

Applies to afamelanotide: subcutaneous implant Side Effects associated with afamelanotide. Some dosage forms listed on this page may not apply specifically to the brand name Scenesse.

Applies to afamelanotide: subcutaneous implant.

Precautions

It is very important that your doctor check your progress at regular visits to make sure the implant is in the proper place and is working properly.

You may have some darkening of the skin and skin lesions while receiving this medicine. A regular full body skin examination (twice yearly) is needed to check for pre-existing and new skin lesions.

Wear protective clothing and hats and stay out of any bright light, or direct sunlight especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds. These would help prevent blisters, itching, rash, redness, swelling, or burning sensation of the skin.

Serious side effects of Scenesse

Along with its needed effects, afamelanotide (the active ingredient contained in Scenesse) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking afamelanotide:

Other side effects of Scenesse

Some side effects of afamelanotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to afamelanotide: subcutaneous implant.

General adverse events

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, Haemorrhage, 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 (up to 26%)
• Common (1% to 10%): Oropharyngeal pain, diarrhea, abdominal pain, toothache

Other

• Common (1% to 10%): Fatigue^[Ref]

Respiratory

• Very common (Greater than 10%): Nasopharyngitis (18%)
• Common (1% to 10%): Cough, respiratory tract infection, sinusitis^[Ref]

Nervous system

• Very common (Greater than 10%): Headache (38%)
• Common (1% to 10%): Dizziness, somnolence, migraine^[Ref]

Local

• Common (1% to 10%): Implant site pain, implant site discoloration

Musculoskeletal

• Very common (Greater than 10%): Back pain (10%)
• Common (1% to 10%): Arthralgia

See also:

Further information

Scenesse side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer