scenesse
Scenesse (Afamelanotide) is a medication used to treat Erythropoietic Protoporphyria.
Afamelanotide · by Clivunel Inc
Key facts
- Active ingredient
- Afamelanotide
- Form
- Implant
- Strength
- Afamelanotide 16MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- erythropoietic protoporphyria
- Manufacturer
- Clivunel Inc
- FDA application
- NDA210797
What is Scenesse?
From the FDA label: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). Afamelanotide acetate has the following structure: Ac-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH 2 • xCH 3 COOH. Afamelanotide is a white to off-white powder, freely soluble in water. Each SCENESSE implant contains 16 mg of afamelanotide (equivalent to 18 mg of afamelanotide acetate), and 15.3-19.5 mg of poly (DL-lactide-co-glycolide). SCENESSE implant is a single, solid white to off-white, bioresorbable and sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. The implant core comprises of the drug substance admixed with a poly (DL-lactide-co-glycolide) bioresorbable copolymer.
How to use
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…
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. 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…
Warnings
Important safety information
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. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and remove the SCENESSE implant if needed. The patient should not receive any further treatment with SCENESSE . Skin Monitoring: May induce darkening of pre-existing nevi and ephelides due to its pharmacological effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing nevi and new skin pigmentary lesions .
Who should not take Scenesse
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 .
May treat (source: NIH RxClass)
Dosage forms
Implant
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Scenesse treat?
- Scenesse (Afamelanotide) may be used to treat erythropoietic protoporphyria, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Scenesse?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Scenesse. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Scenesse?
- Scenesse is marketed by Clivunel Inc. You can see Clivunel Inc's full profile, rating, and other products on pharmaranks.
- Is Scenesse a brand-name or generic drug?
- Scenesse is a brand-name product with the active ingredient Afamelanotide.
- Is Scenesse available over the counter?
- No. Scenesse is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Scenesse come in?
- Scenesse is currently marketed as implant, per the FDA's National Drug Code Directory.
- Is Scenesse FDA-registered?
- Scenesse is on record with the U.S. FDA under application number NDA210797. You can verify this on its official FDA label.
- Is Scenesse safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Scenesse. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Scenesse?
- Scenesse's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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