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.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS:

• None

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

• Store in refrigerator 2C to 8C (36F to 46F); protect from light

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

• 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.

• 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

• 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.