Afamelanotide
Generic Name: afamelanotide
Brand Names:
Scenesse
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 •xC 2 H 4 O 2 (3 ≤ x ≤ 4). The molecular weight of afamelanotide is 1646.85 (anhydrous free base).
Overview
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 •xC 2 H 4 O 2 (3 ≤ x ≤ 4). The molecular weight of afamelanotide is 1646.85 (anhydrous free base).
Uses
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
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.
Side Effects
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.
Warnings
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. [ 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. 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 .
Storage
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 ].
Frequently Asked Questions
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)
What are the side effects of Afamelanotide?▼
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.
What are the important warnings for Afamelanotide?▼
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. [ 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. 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 .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.