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Afamelanotide Dosage

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Porphyria

16 mg implanted subcutaneously above the anterior supra-iliac crest every 2 months

Comments:
-This drug should be implanted by a health care professional proficient in the subcutaneous implantation procedure.
-Patients should maintain sun and light protection measures during treatment to prevent phototoxic reactions.

Use: To increase pain free light exposure in patients with a history of phototoxic reactions from erythropoietic protoporphyria.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be implanted by a healthcare provider who has been trained in proper implantation
-Subcutaneous implantation requires a suitable implantation cannula; implantation cannulas are not supplied with product

Storage requirements:
-Store in refrigerator 2C to 8C (36F to 46F); protect from light

Preparation techniques:
-Training programs are provided by the manufacturer (Clinuvel); a video is available at http://www.clinuvel.com/US-HCP

General:
-Studies have shown this drug allows patients with erythropoietic protoporphyria (EPP) to spend more time outdoors in direct sunlight with no pain.
-Patients should maintain sun and light protection measures during treatment to prevent phototoxic reactions.

Monitoring:
-Monitor patient for 30 minutes after implant administration.
-A full body skin examination should be performed twice a year to monitor preexisting nevi and other skin abnormalities.

Patient advice:
-Patients should be advised to contact their healthcare provider if their implant is expelled.
-Patients should be advised that the dressing can be removed 24-hours after implantation.
-Patients should be advised to monitor insertion site and report reactions to their healthcare provider.
-Patients should be advised to maintain sun and light protection measures during treatment to prevent phototoxic reactions.
-Patients should be advised that they may see darkening of preexisting nevi or other skin abnormalities and that will undergo twice yearly full body skin examinations to monitor for this.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.