U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C78H111N21O19.3C2H4O2
Molecular Weight 1827.0011
Optical Activity UNSPECIFIED
Defined Stereocenters 12 / 12
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of AFAMELANOTIDE ACETATE

SMILES

CC(O)=O.CC(O)=O.CC(O)=O.CCCC[C@H](NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(C)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC2=CNC=N2)C(=O)N[C@H](CC3=CC=CC=C3)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC4=CNC5=CC=CC=C45)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N6CCC[C@H]6C(=O)N[C@@H](C(C)C)C(N)=O

InChI

InChIKey=VHLLBJXKNRAYGM-BHHWPIKXSA-N
InChI=1S/C78H111N21O19.3C2H4O2/c1-5-6-19-52(91-75(116)61(41-101)97-72(113)57(34-46-24-26-49(103)27-25-46)94-74(115)60(40-100)88-44(4)102)68(109)92-54(28-29-64(105)106)70(111)96-59(36-48-38-83-42-87-48)73(114)93-56(33-45-16-8-7-9-17-45)71(112)90-53(22-14-31-84-78(81)82)69(110)95-58(35-47-37-85-51-20-11-10-18-50(47)51)67(108)86-39-63(104)89-55(21-12-13-30-79)77(118)99-32-15-23-62(99)76(117)98-65(43(2)3)66(80)107;3*1-2(3)4/h7-11,16-18,20,24-27,37-38,42-43,52-62,65,85,100-101,103H,5-6,12-15,19,21-23,28-36,39-41,79H2,1-4H3,(H2,80,107)(H,83,87)(H,86,108)(H,88,102)(H,89,104)(H,90,112)(H,91,116)(H,92,109)(H,93,114)(H,94,115)(H,95,110)(H,96,111)(H,97,113)(H,98,117)(H,105,106)(H4,81,82,84);3*1H3,(H,3,4)/t52-,53-,54-,55-,56+,57-,58-,59-,60-,61-,62-,65-;;;/m0.../s1

HIDE SMILES / InChI
Molecular Formula C78H111N21O19
Molecular Weight 1646.8452
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 12 / 12
E/Z Centers 6
Optical Activity UNSPECIFIED
Molecular Formula C2H4O2
Molecular Weight 60.052
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description

Afamelanotide (SCENESSE) is a synthetic α-melanocyte stimulating hormone analog and first-in-class melanocortin-1 receptor agonist that is approved in the EU for the prevention of phototoxicity in adults with erythropoietic protoporphyria. Afamelanotide differs from endogenous α-melanocyte stimulating hormone at the fourth and seventh amino acid residues, increasing its resistance to immediate degradation and increasing its binding time to melanocortin-1 receptor. Afamelanotide is mimic the pharmacological activity of α-melanocyte stimulating hormone by binding to the melanocortin-1 receptor on melanocytes and activating the synthesis of eumelanin. Eumelanin provides photoprotection through mechanisms including, but not limited to, the absorption and scattering of visible and UV light and antioxidant activity. Afamelanotide increases eumelanin density in healthy volunteers and patients with erythropoietic protoporphyria. In healthy, fair-skinned volunteers, a significant increase in melanin density and skin darkening in both sun-exposed and non-sun-exposed sites was seen with subcutaneous injections of afamelanotide. The most common afamelanotide adverse events included headache and nausea. Common adverse effects include back pain, upper respiratory tract infections, decreased appetite, migraine, and dizziness.

Approval Year

2019
334
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
3.7 ng/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
16 mg single, subcutaneous
dose: 16 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
AFAMELANOTIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
138.9 ng × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
16 mg single, subcutaneous
dose: 16 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
AFAMELANOTIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
15 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
16 mg single, subcutaneous
dose: 16 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
AFAMELANOTIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Other AEs: Implant site reaction, Nausea...
Other AEs:
Implant site reaction (grade 1-2, 21%)
Nausea (grade 1-2, 19%)
Oropharyngeal pain (grade 1-2, 7%)
Cough (grade 1-2, 6%)
Fatigue (grade 1-2, 6%)
Skin hyperpigmentation (grade 1-2, 4%)
Dizziness (grade 1-2, 4%)
Melanocytic nevus (grade 1-2, 4%)
Respiratory tract infection (grade 1-2, 4%)
Somnolence (grade 1-2, 2%)
Porphyria non-acute (grade 1-2, 2%)
Skin irritation (grade 1-2, 2%)
Implant site discoloration (grade 1-2, 10%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Other AEs: Abdominal pain, Upper abdominal pain...
Other AEs:
Abdominal pain (grade 1-2, 11%)
Upper abdominal pain (grade 1-2, 3%)
Diarrhea (grade 1-2, 8%)
Vomiting (grade 1-2, 3%)
Fatigue (grade 1-2, 3%)
Implant site discoloration (grade 1-2, 19%)
Viral gastroenteritis (grade 1-2, 3%)
Influenza (grade 1-2, 16%)
Nasopharyngitis (grade 1-2, 21%)
Upper respiratory tract infection (grade 1-2, 8%)
Blood in urine (grade 1-2, 5%)
Back pain (grade 1-2, 5%)
Myalgia (grade 1-2, 3%)
Pain in extremity (grade 1-2, 3%)
Headache (grade 1-3, 34%)
Migraine (grade 1-2, 3%)
Cough (grade 1-2, 13%)
Oropharyngeal pain (grade 1-2, 16%)
Eczema (grade 1-2, 5%)
Pigmentation disorder (grade 1-2, 8%)
Pruritus (grade 1-2, 5%)
Nausea (grade 1-2, 18%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Other AEs: Abdominal discomfort, Abdominal pain...
Other AEs:
Abdominal discomfort (grade 1-2, 2%)
Abdominal pain (grade 1-2, 2%)
Upper abdominal pain (grade 1-2, 2%)
Diarrhea (grade 1-2, 4%)
Dyspepsia (grade 1-2, 6%)
Toothache (grade 1-2, 6%)
Vomiting (grade 1-2, 2%)
Implant site discoloration (grade 1-2, 11%)
Pain (grade 1-2, 8%)
Influenza (grade 1-2, 4%)
Nasopharyngitis (grade 1-2, 12%)
Sinusitis (grade 1-2, 6%)
Upper respiratory tract infection (grade 1-2, 2%)
Arthralgia (grade 1-2, 10%)
Back pain (grade 1-2, 12%)
Musculoskeletal pain (grade 1-2, 6%)
Myalgia (grade 1-2, 6%)
Pain in extremity (grade 1-2, 4%)
Dizziness (grade 1-2, 2%)
Headache (grade 1-2, 40%)
Migraine (grade 1-2, 6%)
Sinus headache (grade 1-2, 2%)
Cough (grade 1-2, 2%)
Oropharyngeal pain (grade 1-2, 4%)
Pigmentation disorder (grade 1-2, 2%)
Pruritus (grade 1-2, 4%)
Melanocytic nevus (grade 1-2, 4%)
Nausea (grade 1-2, 19%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
0.16 mg/kg 10 times / month multiple, subcutaneous
MTD
Dose: 0.16 mg/kg, 10 times / month
Route: subcutaneous
Route: multiple
Dose: 0.16 mg/kg, 10 times / month
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
Disc. AE: Nausea...
AEs leading to
discontinuation/dose reduction:
Nausea
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
18 mg 1 times / 60 days multiple, subcutaneous (mean)
Studied dose
Dose: 18 mg, 1 times / 60 days
Route: subcutaneous
Route: multiple
Dose: 18 mg, 1 times / 60 days
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005321-40/results
unhealthy, adult
n = 36
Health Status: unhealthy
Condition: Polymorphous Light Eruption
Age Group: adult
Sex: M+F
Population Size: 36
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005321-40/results
Disc. AE: Crohn's disease...
AEs leading to
discontinuation/dose reduction:
Crohn's disease
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005321-40/results
20 mg 1 times / 2 months multiple, subcutaneous
Highest studied dose
Dose: 20 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 20 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
unhealthy
n = 43
Health Status: unhealthy
Condition: organ transplant recipients
Population Size: 43
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
40 mg 1 times / day single, subcutaneous
Highest studied dose
Dose: 40 mg, 1 times / day
Route: subcutaneous
Route: single
Dose: 40 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
healthy
n = 6
Health Status: healthy
Population Size: 6
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
Disc. AE: Darkened skin...
AEs leading to
discontinuation/dose reduction:
Darkened skin
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
unhealthy
n = 74
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Population Size: 74
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
Disc. AE: Migraine...
AEs leading to
discontinuation/dose reduction:
Migraine
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
AEs

AEs

AESignificanceDosePopulation
Implant site discoloration grade 1-2, 10%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Nausea grade 1-2, 19%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Porphyria non-acute grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Skin irritation grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Somnolence grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Implant site reaction grade 1-2, 21%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Dizziness grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Melanocytic nevus grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Respiratory tract infection grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Skin hyperpigmentation grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Cough grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Fatigue grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Oropharyngeal pain grade 1-2, 7%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
unhealthy, 18 to 74 years
n = 125
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 18 to 74 years
Sex: M+F
Population Size: 125
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
Abdominal pain grade 1-2, 11%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Cough grade 1-2, 13%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Influenza grade 1-2, 16%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Oropharyngeal pain grade 1-2, 16%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Nausea grade 1-2, 18%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Implant site discoloration grade 1-2, 19%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Nasopharyngitis grade 1-2, 21%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Fatigue grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Migraine grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Myalgia grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pain in extremity grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Upper abdominal pain grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Viral gastroenteritis grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Vomiting grade 1-2, 3%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Back pain grade 1-2, 5%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Blood in urine grade 1-2, 5%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Eczema grade 1-2, 5%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pruritus grade 1-2, 5%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Diarrhea grade 1-2, 8%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pigmentation disorder grade 1-2, 8%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Upper respiratory tract infection grade 1-2, 8%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Headache grade 1-3, 34%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 38.3
n = 38
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 38.3
Sex: M+F
Population Size: 38
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Arthralgia grade 1-2, 10%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Implant site discoloration grade 1-2, 11%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Back pain grade 1-2, 12%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Nasopharyngitis grade 1-2, 12%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Nausea grade 1-2, 19%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Abdominal discomfort grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Abdominal pain grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Cough grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Dizziness grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pigmentation disorder grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Sinus headache grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Upper abdominal pain grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Upper respiratory tract infection grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Vomiting grade 1-2, 2%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Diarrhea grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Influenza grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Melanocytic nevus grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Oropharyngeal pain grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pain in extremity grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pruritus grade 1-2, 4%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Headache grade 1-2, 40%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Dyspepsia grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Migraine grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Musculoskeletal pain grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Myalgia grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Sinusitis grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Toothache grade 1-2, 6%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Pain grade 1-2, 8%
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
unhealthy, 40.4
n = 48
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Age Group: 40.4
Sex: M+F
Population Size: 48
Sources:
https://pubmed.ncbi.nlm.nih.gov/26132941/
Nausea Disc. AE
0.16 mg/kg 10 times / month multiple, subcutaneous
MTD
Dose: 0.16 mg/kg, 10 times / month
Route: subcutaneous
Route: multiple
Dose: 0.16 mg/kg, 10 times / month
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
Crohn's disease Disc. AE
18 mg 1 times / 60 days multiple, subcutaneous (mean)
Studied dose
Dose: 18 mg, 1 times / 60 days
Route: subcutaneous
Route: multiple
Dose: 18 mg, 1 times / 60 days
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005321-40/results
unhealthy, adult
n = 36
Health Status: unhealthy
Condition: Polymorphous Light Eruption
Age Group: adult
Sex: M+F
Population Size: 36
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005321-40/results
Darkened skin Disc. AE
40 mg 1 times / day single, subcutaneous
Highest studied dose
Dose: 40 mg, 1 times / day
Route: subcutaneous
Route: single
Dose: 40 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
healthy
n = 6
Health Status: healthy
Population Size: 6
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000OtherR.pdf
Migraine Disc. AE
16 mg 1 times / 2 months multiple, subcutaneous
Recommended
Dose: 16 mg, 1 times / 2 months
Route: subcutaneous
Route: multiple
Dose: 16 mg, 1 times / 2 months
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
unhealthy
n = 74
Health Status: unhealthy
Condition: erythropoietic protoporphyria
Population Size: 74
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1612

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP
111
CYP
76
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
CYP
147
 unlikely
CYP
147
 unlikely
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1647
Sourcing

Sourcing

Vendor/AggregatorIDURL
AN PharmaTech
AN-37109
Ambinter
Amb19930648
http://www.ambinter.com/reference/19930648
ChemMol
49423239
http://www.chemmol.com/chemmol/49423239.html
Chemieliva Pharmaceutical Co., Ltd
PBCM0816867
MuseChem
P000195
https://www.musechem.com/product/P000195.html
Parchem
29363
http://www.parchem.com/chemical-supplier-distributor/Melanotan-019363.aspx
PubChem
16197727
https://pubchem.ncbi.nlm.nih.gov/compound/16197727
eNovation Chemicals
D680237
https://www.enovationchem.com/ProductDetails.asp?ProductID=D680237
iChemical
EBD23779
http://www.ichemical.com/chemicals/cas-75921-69-6
PubMed

PubMed

TitleDatePubMed
4-Norleucine, 7-D-phenylalanine-alpha-melanocyte-stimulating hormone: a highly potent alpha-melanotropin with ultralong biological activity.
1980 Oct
Proopiomelanocortin processing in the pituitary, central nervous system, and peripheral tissues.
1988 Feb
Skin pigmentation and pharmacokinetics of melanotan-I in humans.
1997 Apr
Characterization of melanocortin receptor ligands on cloned brain melanocortin receptors and on grooming behavior in the rat.
1999 Aug 13
Molecular determinants of ligand binding to the human melanocortin-4 receptor.
2000 Dec 5
Pharmacologic response of a controlled-release PLGA formulation for the alpha-melanocyte stimulating hormone analog, Melanotan-I.
2000 May
The role of melanocortins in body weight regulation: opportunities for the treatment of obesity.
2002 Apr 12

Sample Use Guides

In Vivo Use Guide
Afamelanotide is supplied in a biodegradable, controlled-release implant containing 16 mg of the active drug, which is to be administered subcutaneously in the area above the suprailiac crest using a 14-gauge catheter with needle
Route of Administration: Other
Substance Class Chemical
Created
by admin
on Sat Dec 16 05:01:03 GMT 2023
Edited
by admin
on Sat Dec 16 05:01:03 GMT 2023
Record UNII
1XCC161YKC
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
AFAMELANOTIDE ACETATE
USAN  
Official Name English
CUV1647 ACETATE
Code English
AC-SER-TYR-SER-NLE-GLU-HIS-D-PHE-ARG-TRP-GLY-LYS-PRO-VAL-NH2.3 HOAC
Common Name English
A-MELANOTROPIN, 4(NLE)-7(D-PHE)
Common Name English
CUV-1647 ACETATE
Code English
AFAMELANOTIDE ACETATE [USAN]
Common Name English
AFAMELANOTIDE TRIACETATE
Common Name English
Afamelanotide acetate [WHO-DD]
Common Name English
SCENESSE
Brand Name English
Classification Tree Code System Code
EU-Orphan Drug EU/3/08/541
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
Code System Code Type Description
RXCUI
2278002
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
PRIMARY
CAS
1566590-77-9
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
NON-SPECIFIC STOICHIOMETRY
NCI_THESAURUS
C166521
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
PRIMARY
USAN
EF-158
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
PRIMARY
CHEBI
136034
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
PRIMARY
FDA UNII
1XCC161YKC
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
PRIMARY
PUBCHEM
133083079
Created by admin on Sat Dec 16 05:01:03 GMT 2023 , Edited by admin on Sat Dec 16 05:01:03 GMT 2023
PRIMARY
Related Record Type Details
Structure of AFAMELANOTIDE
PARENT -> SALT/SOLVATE
Related Record Type Details
Structure of AFAMELANOTIDE
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