Applies to afamelanotide: subcutaneous implant.

Serious side effects of Afamelanotide

Along with its needed effects, afamelanotide 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:

More common

• Bruising, discoloration of the skin, itching, redness, swelling, or pain at the implant site

Less common

• Cough
• fever
• sneezing
• sore throat

Other side effects of Afamelanotide

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:

More common

• Nausea
• unusual tiredness or weakness

Less common

• Darkening of the skin or lips
• dizziness
• sleepiness or unusual drowsiness

For Healthcare Professionals

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, 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