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.

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
• Sterile gauze, adhesive bandage, pressure bandage
Step 1
• Take the carton containing SCENESSE out of the refrigerator to allow the product to gradually warm up to
ambient temperature.
• Remove the seal and stopper from the glass vial containing SCENESSE. Remove the implant from the vial
using the blunt forceps under aseptic conditions and place the implant on a sterile gauze.

Step 2
Put the patient in a comfortable reclined supine position.
Identify the insertion site 3-4 cm above the anterior suprailiac
crest and disinfect the skin surface.

Step 3 (optional)
Anesthetize the area of insertion (puncture) if deemed
necessary and in consultation with the patient

Step 4
While pinching the skin of the insertion site, insert the
cannula with the bevel facing upwards (away from the
abdomen) at a 30-45° angle into the subcutaneous layer.
Advance the cannula 2 cm into the subcutaneous layer.

Step 5
• Remove the stylet (obturator) from the cannula
maintaining aseptic precautions
• Load the implant into the cannula
• Using the stylet (obturator) gently push the implant
down the full length of the cannula’s shaft

Step 6
Apply pressure to the site of the implant while removing the
stylet (obturator) and the cannula. Verify that no implant or
implant portion remains in the cannula.

Step 7
Verify the correct insertion and placement of the implant by
palpating the skin overlying the implant.

Step 8
Apply dressing to the insertion site. Leave dressing in place
for 24 hours.

Step 9
Monitor the patient for 30 minutes after the implant
administration.