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 approved; investigational
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
UNII 18EAY4870E
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Adenoma benign16.02.02.001--Not Available
Alanine aminotransferase13.03.04.002--Not Available
Alanine aminotransferase increased13.03.04.005--
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase13.03.04.008--Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Body temperature increased13.15.01.001--Not Available
Chills15.05.03.016; 08.01.09.001--
Discomfort08.01.08.003--Not Available
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Glomerulonephritis10.02.01.006; 20.05.01.001--Not Available
Haematoma24.07.01.001--
Headache17.14.01.001--
Hepatic steatosis14.08.04.005; 09.01.07.003--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Influenza like illness08.01.03.010--
Injection site reaction12.07.03.015; 08.02.03.014--
Insomnia19.02.01.002; 17.15.03.002--
Liver function test abnormal13.03.04.030--Not Available
Malaise08.01.01.003--
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