Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mipomersen sodium
Drug ID BADD_D01474
Description Mipomersen sodium, which was known as the investigational drug, isis-301012, is the salt form of a synthetic phosphorothioate oligonucleotide. Mipomersen sodium prevents the formation of apo B-100, resulting in a decrease in the levels of apolipoprotein B (apo B), low density lipoprotein (LDL), and total cholesterol. Mipomersen is indicated in patients with homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering medications. It is marketed under the brand name Kynamro in the United States, and the FDA label includes a black box warning of hepatoxicity. Specifically, elevations in the liver enzymes, i.e. transaminases, and in liver fat (hepatic steatosis) have been reported. Due to this serious risk of liver toxicity, mipomersen sodium is only available to patients under the restricted program called Kynamro Risk Evaluation and Mitigation Strategy program.
Indications and Usage Used in patients with homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering medications.
Marketing Status Prescription
ATC Code C10AX11
DrugBank ID DB05528
KEGG ID D08946
MeSH ID C524142
PubChem ID 44564107
TTD Drug ID Not Available
NDC Product Code Not Available
Synonyms mipomersen | ISIS 301012 | ISIS301012 | ISIS-301012 | Kynamro | mipomersen sodium
Chemical Information
Molecular Formula C230H305N67Na19O122P19S19
CAS Registry Number 629167-92-6
SMILES CC1=CN(C(=O)NC1=O)C2CC(C(O2)COP(=O)([O-])SC3CC(OC3COP(=O)([O-])SC4CC(OC4COP(=O)( [O-])SC5CC(OC5COP(=O)([O-])SC6CC(OC6COP(=O)([O-])SC7CC(OC7COP(=O)([O-])SC8CC(OC8 COP(=O)([O-])SC9CC(OC9COP(=O)([O-])SC1C(OC(C1OCCOC)N1C=C(C(=NC1=O)N)C)COP(=O)([O -])SC1C(OC(C1OCCOC)N1C=C(C(=O)NC1=O)C)COP(=O)([O-])SC1C(OC(C1OCCOC)N1C=C(C(=NC1= O)N)C)COP(=O)([O-])SC1C(OC(C1OCCOC)N1C=C(C(=NC1=O)N)C)COP(=O)([O-])SC1C(OC(C1OCC OC)N1C=NC2=C1N=C(NC2=O)N)CO)N1C=NC2=C(N=CN=C21)N)N1C=NC2=C1N=C(NC2=O)N)N1C=C(C(= O)NC1=O)C)N1C=C(C(=NC1=O)N)C)N1C=C(C(=O)NC1=O)C)N1C=NC2=C1N=C(NC2=O)N)N1C=C(C(=N C1=O)N)C)SP(=O)([O-])OCC1C(CC(O1)N1C=C(C(=O)NC1=O)C)SP(=O)([O-])OCC1C(CC(O1)N1C= C(C(=NC1=O)N)C)SP(=O)([O-])OCC1C(C(C(O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)SP(=O)([O-]) OCC1C(C(C(O1)N1C=C(C(=NC1=O)N)C)OCCOC)SP(=O)([O-])OCC1C(C(C(O1)N1C=NC2=C(N=CN=C2 1)N)OCCOC)SP(=O)([O-])OCC1C(C(C(O1)N1C=C(C(=NC1=O)N)C)OCCOC)SP(=O)([O-])OCC1C(C( C(O1)N1C=C(C(=NC1=O)N)C)OCCOC)O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]. [Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephritis20.05.02.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.01.02.003--
Platelet count13.01.04.011--Not Available
Proteinuria20.02.01.011--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Swelling08.01.03.015--Not Available
Tenderness08.01.08.005--Not Available
Tongue discolouration07.14.02.006--Not Available
Vomiting07.01.07.003--
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Transaminases increased13.03.01.015--Not Available
Angiopathy24.03.02.007--Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Cardiac disorder02.01.01.003--Not Available
Connective tissue disorder15.06.01.006--Not Available
Mental disorder19.07.01.002--Not Available
Antibody test negative13.06.03.008--Not Available
Ill-defined disorder08.01.03.049--Not Available
Hepatobiliary disease09.01.08.003--Not Available
The 2th Page    First    Pre   2 3    Next   Last    Total 3 Pages