SCENESSE

SCENESSE- afamelanotide implant
CSM Clinical Supplies Management Europe GmbH

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
• 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 2
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Step 3 (optional)
Anesthetize the area of insertion (puncture) if deemed necessary and in consultation with the patient

Step 3
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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 4
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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 5
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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 6
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Step 7
Verify the correct insertion and placement of the implant by palpating the skin overlying the implant.

Step 7
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Step 8
Apply dressing to the insertion site. Leave dressing in place
for 24 hours.

Step 8

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

Step 9
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Implant: 16 mg of afamelanotide as a solid white to off-white, bioresorbable, sterile rod approximately 1.7 cm in length
and 1.45 mm in diameter.

None.

Skin Monitoring

SCENESSE may lead to generalized increased skin pigmentation and darkening of pre-existing nevi and ephelides because
of its pharmacologic effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing and new
skin pigmentary lesions.

Clinical Trials Experience


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials
of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in
practice.
The safety of SCENESSE was evaluated in 3 randomized, multicenter, prospective, vehicle controlled clinical trials (Study
CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with erythropoietic protoporphyria (EPP)
without significant liver involvement. Subjects received subcutaneous SCENESSE implants containing 16 mg of
afamelanotide every 2 months. A total of 125 subjects received SCENESSE and 119 subjects received vehicle implants.
Table 1 summarizes the adverse reactions that occurred in more than 2% of subjects.

Table 1
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Specific Adverse Reactions
Implant Site Reactions: Implant site reactions were more common in the SCENESSE group (21%) compared to the vehicle
group (10%). In the SCENESSE group, the most common implant site reaction was implant site discoloration (10%).

To to report suspected adverse reactions, contact FDA at 1-800-332-1088 or www.fda.gov/medwatch.

Pregnancy

Risk Summary
There are no data on SCENESSE use in pregnant women to evaluate for any drug associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcome.
In animal reproductive and development toxicity studies, no adverse developmental effects were observed with
afamelanotide administration during the period of organogenesis to pregnant rats at subcutaneous doses up to 12 times the
maximum recommended human dose (MRHD) (see Data).
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of
major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated
background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,
respectively.
Data
Animal Data
In embryofetal development studies in Sprague Dawley and Lister Hooded rats, afamelanotide was administered
subcutaneously to pregnant rats at doses of 0.2, 2, or 20 mg/kg/day throughout the period of organogenesis. No adverse
embryofetal developmental effects were observed at doses up to 20 mg/kg/day (12 times the MRHD, based on a body
surface area comparison).
In pre- and post-natal development study in Sprague Dawley rats, afamelanotide was administered subcutaneously
at doses of 0.2, 2, or 20 mg/kg/day during the period of organogenesis through lactation. No treatment-related effects were
observed at doses up to 20 mg/kg/day (12 times the MRHD, based on a body surface area comparison).

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