30/19. Afamelanotide- (Scenesse)-(Oct-2019)- Pain free Phototoxic Reactor Skin damage drug
Drug Name:30/19. Afamelanotide- (Scenesse)-(Oct-2019)- Pain free Phototoxic Reactor Skin damage drug
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Drug Interaction Studies
No drug interaction studies were conducted with afamelanotide.
Indication:
Advise patients to maintain sun and light protection measures during treatment with to prevent phototoxic reactions related to EPP.
Monitoring- Advise patients that darkening of pre-existing nevi and ephelides may occur with useof . A full body skin examination is recommended twice yearly to monitor pre-existing and new skin pigmentary lesions.
Adverse Reaction:
ADVERSE REACTIONS
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
Contra-Indications:
WARNINGS AND PRECAUTIONS
Skin monitoring:
May induce darkening of pre-existing nevi and ephelides due to its pharmacological effect. A regular full body skin examination (twice yearly) is recommended to monitor all nevi and other skin abnormalities.
Dosages/ Overdosage Etc:
Patient Information:
PATIENT COUNSELING INFORMATION
Concomitant Measures
Advise patients to maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP.
Monitoring
Advise patients that darkening of pre-existing nevi and ephelides may occur with use of SCENESSE. A full body skin examination is recommended twice yearly to monitor pre-existing and new skin pigmentary lesions.
Expelled Implant
Advise patients to contact their healthcare provider if the implant is expelled. Dressing removal
Advise patients that the dressing can be removed after 24 hours.
Insertion Site Care and Monitoring
Advise patients to monitor the insertion site after dressing removal and to report any reaction observed at the site to their healthcare provider.
Manufactured for:
CLINUVEL, INC. 2419 Sharon Oaks Dr West Menlo Park, CA 94025
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Afamelanotide is a synthetic tridecapeptide and a structural analog of a-melanocyte stimulating hormone (a-MSH). Afamelanotide is a melanocortin receptor agonist and binds predominantly to MC1-R.
2. Pharmacodynamics
Afamelanotide increases production of eumelanin in the skin independently of exposure to sunlight or artificial UV light sources.
3. Pharmacokinetics
The pharmacokinetics of afamelanotide following administration of a single subcutaneous implant of SCENESSE were evaluated in 12 healthy adults.
High variability was observed in the plasma concentrations of afamelanotide and for most subjects (9 out of 12), the last measurable afamelanotide concentration was at 96 hours post-dose.
The mean ± SD Cmax and AUC0-inf were 3.7 ± 1.3 ng/mL and 138.9 ± 42.6 hr*ng/mL, respectively.
Absorption
The median Tmax was 36 hr.
Elimination
The apparent half-life of afamelanotide is approximately 15 hr when administered subcutaneously in a controlled release implant.
Metabolism
Afamelanotide may undergo hydrolysis. However, its metabolic profile has not been fully characterized.
Specific Populations
The effect of renal or hepatic impairment on the pharmacokinetics of afamelanotide is unknown.
Drug Interaction Studies
No drug interaction studies were conducted with afamelanotide.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary
There are no data on SCENESSE use in pregnant women to evaluate for any drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome.
In animal reproductive and development toxicity studies, no adverse developmental effects were observed with afamelanotide administration during the period of organogenesis to pregnant rats at subcutaneous doses up to 12 times the maximum recommended human dose (MRHD) (see Data).
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
2. Lactation Risk Summary
There are no data on the presence of afamelanotide or any of its metabolites in human or animal milk, the effects on the breastfed infant, or the effect on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SCENESSE and any potential adverse effects on the breastfed infant from SCENESSE or from the underlying maternal condition.
3. Pediatric Use
The safety and effectiveness of SCENESSE have not been established in pediatric patients.
4. Geriatric Use
There were 10 subjects 65 years old and over in the clinical studies for EPP
Of the 125 subjects treated with SCENESSE in these studies, 4 (3%) were 65 years of age and older.
Clinical studies of SCENESSE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.