Scenesse Implants
Generic name:afamelanotide
Dosage form: subcutaneous implant
Drug class:Melanocortin receptor agonists
Medically reviewed by Drugs.com. Last updated on Sep 1, 2021.
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These highlights do not include all the information needed to use SCENESSE .
See full prescribing information for SCENESSE.
Initial U.S. Approval: 2019
SCENESSE® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
Important Dosage and Administration Information
SCENESSE should be administered by a health care professional. All healthcare professionals should be proficient in the
subcutaneous implantation procedure and have completed the training program provided by CLINUVEL prior to
administration of the SCENESSE implant [see Dosage and Administration (2.2)]. Additional information, including a
video, is available at http://www.clinuvel.com/US-HCP. The additional information has not been evaluated or approved by
the FDA.
A single SCENESSE implant is inserted subcutaneously above the anterior supra-iliac crest every 2 months.
Use the SFM Implantation Cannula to implant SCENESSE. Contact CLINUVEL INC. for other implantation devices that
have been determined by the manufacturer to be suitable for implantation of SCENESSE.
Maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to
EPP.
Instructions for Implantation of SCENESSE
Insert a single SCENESSE implant (containing 16 mg of afamelanotide) subcutaneously above the anterior supra-iliac
crest.
Implant SCENESSE observing an aseptic technique. The following equipment is needed for the implant insertion:
• SCENESSE implant
• SFM Implantation Cannula; use of a device that has not been determined to be suitable could result in damage to
the SCENESSE implant [see Dosage and Administration (2.1)].
• Sterile gloves
• Local anesthetic, needle and syringe
• Blunt forceps suitable for removing the SCENESSE implant from the glass vial and placement of the SCENESSE
implant
• Ste
