SCENESSE- afamelanotide implant
SCENESSE® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
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]. 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].
- 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
- 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.
Put the patient in a comfortable reclined supine position. Identify the insertion site 3-4 cm above the anterior supra-iliac crest and disinfect the skin surface.
Step 3 (optional) Anesthetize the area of insertion (puncture) if deemed necessary and in consultation with the patient.
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.
- 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.
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.
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.
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.
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.
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: Adverse Reactions Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039, CUV030, and CUV029).
|Adverse Reaction||SCENESSE n (%) N = 125||Vehicle n (%) N = 119|
|Implant site reaction 1||26 (21%)||12 (10%)|
|Nausea||24 (19%)||17 (14%)|
|Oropharyngeal pain||9 (7%)||6 (5%)|
|Cough||8 (6%)||4 (3%)|
|Fatigue||7 (6%)||3 (3%)|
|Skin hyperpigmentation 2||5 (4%)||0 (0%)|
|Dizziness||5 (4%)||4 (3%)|
|Melanocytic nevus||5 (4%)||2 (2%)|
|Respiratory tract infection||5 (4%)||3 (3%)|
|Somnolence||3 (2%)||1 (1%)|
|Non-acute porphyria||2 (2%)||0 (0%)|
|Skin irritation||2 (2%)||0 (0%)|
1: Implant site reaction includes: implant site bruising, discoloration, erythema, hemorrhage, hypertrophy, irritation, nodule, pain, pruritus, swelling;
injection site bruising and erythema; and expelled implant.
2: Skin hyperpigmentation includes skin hyperpigmentation, pigmentation lip (subject also had skin hyperpigmentation), and pigmentation disorder.
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%).
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.