Afamelanotide
FDA Drug Information • Also known as: Scenesse
- Brand Names
- Scenesse
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
Description
Descripton SCENESSE (afamelanotide) implant is a controlled-release dosage form for subcutaneous administration. Afamelanotide is a melanocortin 1 receptor (MC1-R) agonist. The active ingredient afamelanotide acetate is a synthetic peptide containing 13 amino acids with molecular formula C 78 H 111 N 21 O 19
What Is Afamelanotide Used For?
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)...
Side Effects (Adverse Reactions)
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SCENESSE was evaluated in 3 randomized, multicenter, prospective, vehicle controlled clinical trials (Study CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with erythropoietic protoporphyria (EPP) without significant liver involvement. Subjects received subcutaneous SCENESSE implants containing 16 mg of afamelanotide every 2 months. A total of 125 subjects received SCENESSE and 119 subjects received vehicle implants. Table 1 summarizes the adverse reactions that occurred in more than 2% of subjects. Table 1: Adverse Reactions Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039, CUV030, and CUV029). Table 1: Adverse Reactions Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039, CUV030, and CUV029) Adverse Reaction SCENESSE n (%) N = 125 Vehicle n (%) N = 119 Implant site reaction 1 26 (21%) 12 (10%) Nausea 24 (19%) 17 (14%) Oropharyngeal pain 9 (7%) 6 (5%) Cough 8 (6%) 4 (3%) Fatigue 7 (6%) 3 (3%) Skin hyperpigmentation 2 5 (4%) 0 (0%) Dizziness 5 (4%) 4 (3%) Melanocytic nevus 5 (4%) 2 (2%) Respiratory tract infection 5 (4%) 3 (3%) Somnolence 3 (2%) 1 (1%) Non-acute porphyria 2 (2%) 0 (0%) Skin irritation 2 (2%) 0 (0%) 1 : Implant site reaction includes: implant site bruising, discoloration, erythema, hemorrhage, hypertrophy, irritation, nodule, pain, pruritus, swelling; injection site bruising and erythema; and expelled implant. 2 : Skin hyperpigmentation includes skin hyperpigmentation, pigmentation lip (subject also had skin hyperpigmentation), and pigmentation disorder. Specific Adverse Reactions Implant Site Reactions : Implant site reactions were more common in the SCENESSE group (21%) compared to the vehicle group (10%). In the SCENESSE group, the most common implant site reaction was implant site discoloration (10%). The most common adverse reactions (incidence > 2%) are implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation . To report SUSPECTED ADVERSE REACTIONS, contact CLINUVEL INC. at 1-888-288-2031 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See PATIENT COUNSELING INFORMATION . Postmarketing Experience The following adverse reactions have been identified during post-approval use of SCENESSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: hypersensitivity (urticaria, angioedema, and anaphylaxis) [ see Warnings and Precautions ]. Postmarketing Experience The following adverse reactions have been identified during post-approval use of SCENESSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: hypersensitivity (urticaria, angioedema, and anaphylaxis) [ see Warnings and Precautions ].
Contraindications
CONTRAINDICATIONS SCENESSE is contraindicated in patients with a history of severe hypersensitivity reaction to afamelanotide or to any of the excipients in SCENESSE . Known hypersensitivity to afamelanotide or to any of the excipients in SCENESSE .
How Supplied
SCENESSE (afamelanotide) implant, 16 mg, for subcutaneous administration (NDC 73372-0116-1) is supplied in a Type I amber glass vial sealed with a PTFE coated rubber stopper. Each vial contains one afamelanotide implant and is packaged individually in a cardboard box. SCENESSE implant is a solid white to off-white, bioresorbable and sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. Store in a refrigerator at 2°C – 8°C (36°F-46°F). Protect from light. SCENESSE implants are not supplied with an implantation device for subcutaneous administration [ see Dosage and Administration ].
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.