General MedicationsSUBCUTANEOUSHigh Alert

SCENESSE

AFAMELANOTIDE

Standard Dose

Important Dosage and Administration Information 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. Insert a single SCENESSE implant subcutaneously above the anterior supra-iliac crest every 2 months. Use the SFM Implantation Cannula to implant SCENESSE. Maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP. SCENESSE should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration . Insert a single implant, containing 16 mg of afamelanotide, using an Cannula . Administer SCENESSE subcutaneously every 2 months . See Full Prescribing Information for instructions for removal of SCENESSE . Instructions for Implantation of SCENESSE 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 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. Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Instructions for Removal of SCENESSE In case a clinical necessity arises to remove the implant, follow the procedure described below: • palpate the area of implant insertion • locate the position of the implant (*Note that the implant is resorbable and may not be able to be located from 10 days after insertion) • inject local anesthetic at the site of foreseen puncture • wait for the local anesthetic to take effect • puncture the dermis at the site of previous insertion • digitally locate the trajectory of the implant • put digital pressure on the dermis– at the distal end of the implant • remove the implant by digitally pushing the implant out towards the puncture site (aperture) • use a pressure compress or band aid on the aperture • observe the patient for 15 minutes after removal of the implant • instruct the patient to maintain the pressure compress for 12 hours. *Note: The implant may not be palpable due to resorption, and removal would likely not be possible. In the unlikely event of the need to surgically remove SCENESSE, it may be localized by ultrasound.

Max Dose

See official label

Primary Use

SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Summary

Indications and usage SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) Dosage and administration Important Dosage and Administration Information SCENESSE should be administered by a health care professional.

Structured Monograph

Clinical summary

Indications and usage SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) Dosage and administration Important Dosage and Administration Information 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. Insert a single SCENESSE implant subcutaneously above the anterior supra-iliac crest every 2 months. Use the SFM Implantation Cannula to implant SCENESSE. Maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP. SCENESSE should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration . Insert a single implant, containing 16 mg of afamelanotide, using an Cannula . Administer SCENESSE subcutaneously every 2 months . See Full Prescribing Information for instructions for removal of SCENESSE . Instructions for Implantation of SCENESSE 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 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. Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Instructions for Removal of SCENESSE In case a clinical necessity arises to remove the implant, follow the procedure described below: • palpate the area of implant insertion • locate the position of the implant (*Note that the implant is resorbable and may not be able to be located from 10 days after insertion) • inject local anesthetic at the site of foreseen puncture • wait for the local anesthetic to take effect • puncture the dermis at the site of previous insertion • digitally locate the trajectory of the implant • put digital pressure on the dermis– at the distal end of the implant • remove the implant by digitally pushing the implant out towards the puncture site (aperture) • use a pressure compress or band aid on the aperture • observe the patient for 15 minutes after removal of the implant • instruct the patient to maintain the pressure compress for 12 hours. *Note: The implant may not be palpable due to resorption, and removal would likely not be possible. In the unlikely event of the need to surgically remove SCENESSE, it may be localized by ultrasound. Warnings and cautions Hypersensitivity Skin Monitoring Serious hypersensitivity reactions, including a

Monitoring

• Hypersensitivity Skin Monitoring Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SCENESSE.
• Warn patients of the risk of hypersensitivity reactions, including anaphylaxis.
• If a serious hypersensitivity reaction occurs, initiate appropriate therapy and remove the SCENESSE implant if needed [ see Dosage and Administration ].
• The patient should not receive any further treatment with SCENESSE.

Interaction Notes

• Review official label interaction section.