Afamelanotide

What is Afamelanotide?

• Afamelanotide (Scenesse) is a melanocortin 1 receptor (MC1-R) agonist used to prevent skin damage from the sun in people with erythropoietic protoporphyria.

What are the uses of this medicine?

• This medicine is used to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

How does this medicine work?

• A synthetic peptide analogue of the naturally occurring alpha-melanocyte stimulating hormone (a-MSH) with potential photoprotective activity. Mimicking the action of a-MSH, afamelanotide stimulates melanocytes to increase the production and release of melanin.
• Increased melanocyte melanin may protect against ultraviolet radiation (UVR)-initiated cellular DNA damage, oxidation of membrane proteins, and alterations in intracellular signaling processes in epidermal cells.
• Endogenously, a-MSH is released by skin cells in response to UVR exposure, stimulating melanocytes to produce and release melanin.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Scenesse should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration.

Recommended Dosage

• Insert a single implant, containing 16 mg of afamelanotide, using an SFM Implantation Cannula or other implantation devices that have been determined by the manufacturer to be suitable for implantation of Scenesse.
• Administer Scenesse subcutaneously every 2 months.

Administration 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 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.

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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Implant: 16 mg of AFAMELANOTIDE

This medicine is available in fallowing brand namesː

• Scenesse

What side effects can this medication cause?

The most common side effects of this medicine include:

• implant site reaction
• nausea
• oropharyngeal pain
• cough
• fatigue
• dizziness
• skin hyperpigmentation
• somnolence
• melanocytic nevus
• respiratory tract infection
• non-acute porphyria
• SKIN IRRITATION

What special precautions should I follow?

• This medicine may induce darkening of pre-existing nevi and ephelides due to its pharmacological effect.
• A regular full body skin examination (twice yearly) is recommended to monitor all nevi and other skin abnormalities.
• Advise patients to maintain sun and light protection measures during treatment with Scenesse to prevent phototoxic reactions related to EPP.
• Advise patients to contact their healthcare provider if the implant is expelled.
• Advise patients to monitor the insertion site after dressing removal and to report any reaction observed at the site to their healthcare provider.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of Scenesse have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• afamelanotide

Who manufactures and distributes this medicine?

• Packager: clinuvel inc.

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 2°C – 8°C (36°F-46°F).
• Protect from light.

• Dailymed label info on Afamelanotide
• FDA Afamelanotide

Afamelanotide Resources
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