Rx Item-Scenesse (afamelanotide) Implant 16mg SubCuta by Clinuvel USA

SCENESSE (afamelanotide) implant, 16 mg, for subcutaneous administration (NDC 73372-0116-1) is supplied in a Type I amber glass vial sealed with a PTFE coated rubber stopper. Each vial contains one afamelanotide implant and is packaged individually in a cardboard box. SCENESSE implant is a solid white to off-white, bioresorbable and sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. Store in a refrigerator at 2�C � 8�C (36�F-46�F). Protect from light. SCENESSE implants are not supplied with an implantation device for subcutaneous administration [see Dosage and Administration (2). HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SCENESSE safely and effectively. See full prescribing information for SCENESSE. SCENESSE� (afamelanotide) implant, for subcutaneous use Initial U.S. Approval: 2019
----------------------------INDICATIONS AND USAGE--------------------------SCENESSE 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). (1)
-----------------------DOSAGE AND ADMINISTRATION----------------------� SCENESSE should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration. (2.1) � Insert 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 of SCENESSE. (2) � Administer SCENESSE subcutaneously every 2 months (2.1).
---------------------DOSAGE FORMS AND STRENGTHS---------------------Implant: 16 mg of afamelanotide. (3)
-----------------------WARNINGS AND PRECAUTIONS-----------------------Skin monitoring: May induce darkening of pre-existing nevi and ephelides due to its pharmacological effect. A regular full body skin examination (twice yearly) is recommended to monitor all nevi and other skin abnormalities. (5.1) ------------------------------ADVERSE REACTIONS------------------------------The most common adverse reactions (incidence > 2%) are implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation (6).
To report SUSPECTED ADVERSE REACTIONS, contact CLINUVEL INC. at 1-415-341-5837 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION

Rx Item-Scenesse (afamelanotide) Implant
RX73372-0116-01

Rx Item-Scenesse (afamelanotide) Implant
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