SCENESSE Implant Ref.[7589] Active ingredients: Afamelanotide

SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant.

Posology

One implant is administered every 2 months prior to expected and during increased sunlight exposure, e.g. from spring to early autumn. Three implants per year are recommended, depending on the length of protection required. The recommended maximum number of implants is four per year. The overall duration of treatment is at the specialist physician’s discretion (see section 4.4).

Special populations

For patients with renal or hepatic impairment see sections 4.3 and 5.2.

Elderly population

Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4).

Paediatric population

The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established.

No data are available.

Method of administration

For subcutaneous use.

Instruction for use:

• Take the packed implant out of the refrigerator and allow the medicinal product to warm up to ambient temperature.
• Have the patient sit in a comfortable position or lie on his/her back with the upper part of the body slightly raised.
• Disinfect the skin above the supra-iliac crest.
• Anaesthetise the insertion area if deemed necessary and in consultation with the patient.
• Select a 14 gauge (1.6 mm inner diameter) catheter with needle.
• Mark 1.5 to 2 cm on the catheter shaft using surgical ink.
• Hold the catheter at its base using a sterile technique, pinch and hold the skinfold cranial to, or overlying the patient’s supra-iliac crest with two fingers.
• With the bevel of the needle facing upwards, insert the catheter laterally 1.5 to 2 cm into the subcutaneous layer at a 30 to 45 degree angle to the skin surface in one continuous flowing movement.
• With the catheter in place, aseptically remove the implant from the vial.
• Remove the needle from within the catheter using a sterile technique.
• Transfer the implant to the outlet of the catheter.
• Using a suitable device (such as a stylet) gently push the implant down the full length of the catheter lumen.
• Apply some pressure to the insertion area with your finger while removing the stylet and the catheter.
• Confirm insertion of the implant by palpating the skin with subcutis cranial to/overlying the suprailiac crest until the implant is located. Always verify the presence of the implant, if in doubt of its presence, check whether the implant has remained in the catheter. If the implant has not been administered during the procedural steps described above, discard the implant and administer a new implant. Do not administer a new implant unless it has been unequivocally confirmed that the first one had not been inserted.
• Apply a small pressure dressing to the injection site.
• Observe the patient for 30 minutes to ensure that you will notice if the patient develops an allergic or hypersensitivity reaction (immediate type).

There are no data available on symptoms or treatment of overdose with afamelanotide.

Shelf life: 4 years.

Store in a refrigerator (2˚C-8˚C).

Type I amber glass vial sealed with a PTFE coated rubber stopper.

Pack of one vial containing one implant.

For instructions on correct administration and preparation see section 4.2.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.