Scenesse (afamelanotide acetate)

Dosage of afamelanotide acetate is expressed in terms of afamelanotide.

Afamelanotide acetate is administered by subcutaneous implantation; it must be administered by a healthcare professional who is proficient in the implantation procedure and has completed training prior to administration.

Each implant contains 16 mg of afamelanotide. Each implant must be inserted above the anterior supra-iliac crest using aseptic technique.

Use the SFM Implantation Cannula or another implantation device determined suitable by the manufacturer to insert the implant. Consult the manufacturer's labeling for more detailed information on the implantation procedure.

Store at 2--8oC protected from light.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with afamelanotide.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Hypersensitivity to the active drug or any excipients.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Increased pigmentation of skin pigmentary lesion

The most common adverse effects occuring in >2% of patients receiving afamelanotide in clinical studies include implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation.

Less Frequent

• Anaphylaxis
• Angioedema

More Frequent

• Implant site reaction
• Nausea

Less Frequent

• Cough
• Dizziness
• Drowsy
• Fatigue
• Hypersensitivity drug reaction
• Increased pigmentation of skin pigmentary lesion
• Pain in oropharynx
• Porphyria
• Progression of nevus
• Skin irritation
• Skin pigmentation enhancement
• Upper respiratory infection
• Urticaria

No enhanced messaging available.

Safety and efficacy of afamelanotide have not been established in pediatric patients.

Data are not available to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse fetal or maternal outcomes.

No adverse developmental effects were observed in animal reproductive studies when afamelanotide was administered during the period of organogenesis to pregnant rats at doses up to 12 times the maximum recommended human dose.

It is not known if afamelanotide or its metabolites are excreted into breast milk. The effects on the breast-fed infant and on milk production are not known. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug, and the potential for adverse effects on the breast-fed child from the drug or from the untreated maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of afamelanotide enrolled an insufficient number of patients >=65 years of age to determine whether they respond differently from younger adults. In clinical studies of erythropoietic protoporphyria, 4 patients receiving afamelanotide were >=65 years of age. Based on other reported experience, no differences in response have been observed between geriatric and younger adult patients.