Afamelanotide (1 brand name, 1 dosage form, 1 route)
Available dosage forms: IMPLANT.
Routes of administration: SUBCUTANEOUS.
Brand Names
- SCENESSE
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).
Dosage and Administration
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.
Contraindications
SCENESSE is contraindicated in patients with a history of severe hypersensitivity reaction to afamelanotide or to any of the excipients in SCENESSE.
Warnings and Precautions
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. [ see Contraindications]. SCENESSE may lead to generalized increased skin pigmentation and darkening of pre-existing nevi and ephelides because of its pharmacologic effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing and new skin pigmentary lesions.
Adverse Reactions
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 (1