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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5137 | 1211327-92-2 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
an interferon beta-1a to which a single, linear 20,000 dalton methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule is covalently attached to the alpha amino group of the N-terminal amino acid residue. A possible role for IFNs in prophylaxis or early treatment of COVID-19 has been suggested to compensate for possibly insufficient endogenous IFN production. However, the efficacy and safety of IFNs for treatment or prevention of COVID-19 were not established.
|
| Dose | Unit | Route |
|---|---|---|
| 8.90 | mcg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 15, 2014 | FDA | BIOGEN IDEC INC |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Influenza like illness | 697.30 | 24.54 | 242 | 5607 | 80369 | 90542229 |
| Multiple sclerosis relapse | 533.81 | 24.54 | 178 | 5671 | 52127 | 90570471 |
| Injection site erythema | 390.71 | 24.54 | 168 | 5681 | 98334 | 90524264 |
| Injection site reaction | 212.04 | 24.54 | 108 | 5741 | 91972 | 90530626 |
| Device malfunction | 135.64 | 24.54 | 51 | 5798 | 20926 | 90601672 |
| Injection site pruritus | 89.68 | 24.54 | 51 | 5798 | 53783 | 90568815 |
| Injection site bruising | 72.49 | 24.54 | 44 | 5805 | 52263 | 90570335 |
| Injection site rash | 69.35 | 24.54 | 33 | 5816 | 24140 | 90598458 |
| Abortion spontaneous | 68.63 | 24.54 | 43 | 5806 | 54013 | 90568585 |
| Maternal exposure during pregnancy | 63.88 | 24.54 | 96 | 5753 | 359967 | 90262631 |
| Drug delivery system malfunction | 61.99 | 24.54 | 15 | 5834 | 1366 | 90621232 |
| Injection site pain | 60.70 | 24.54 | 65 | 5784 | 173634 | 90448964 |
| Lymphopenia | 55.92 | 24.54 | 28 | 5821 | 22853 | 90599745 |
| Chills | 52.58 | 24.54 | 53 | 5796 | 131928 | 90490670 |
| General symptom | 51.37 | 24.54 | 23 | 5826 | 14645 | 90607953 |
| Injection site swelling | 37.49 | 24.54 | 31 | 5818 | 59808 | 90562790 |
| Magnetic resonance imaging abnormal | 35.96 | 24.54 | 12 | 5837 | 3474 | 90619124 |
| Caesarean section | 34.72 | 24.54 | 19 | 5830 | 18558 | 90604040 |
| Leukopenia | 33.93 | 24.54 | 37 | 5812 | 100673 | 90521925 |
| Central nervous system lesion | 33.70 | 24.54 | 16 | 5833 | 11630 | 90610968 |
| Product dose omission issue | 33.32 | 24.54 | 64 | 5785 | 291623 | 90330975 |
| White blood cell count decreased | 33.08 | 24.54 | 47 | 5802 | 167062 | 90455536 |
| Off label use | 33.06 | 24.54 | 15 | 5834 | 1102237 | 89520361 |
| Needle fatigue | 32.13 | 24.54 | 6 | 5843 | 156 | 90622442 |
| Procedural anxiety | 31.86 | 24.54 | 8 | 5841 | 848 | 90621750 |
| Anal polyp | 28.97 | 24.54 | 5 | 5844 | 82 | 90622516 |
| Adverse reaction | 28.84 | 24.54 | 20 | 5829 | 29692 | 90592906 |
| Balance disorder | 28.16 | 24.54 | 33 | 5816 | 97047 | 90525551 |
| Injection site urticaria | 27.14 | 24.54 | 16 | 5833 | 17995 | 90604603 |
| Product administered to patient of inappropriate age | 25.36 | 24.54 | 10 | 5839 | 4643 | 90617955 |
| Gait disturbance | 24.78 | 24.54 | 53 | 5796 | 260443 | 90362155 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Influenza like illness | 330.23 | 35.12 | 87 | 927 | 31753 | 42588568 |
| Multiple sclerosis relapse | 186.18 | 35.12 | 47 | 967 | 14217 | 42606104 |
| Injection site erythema | 86.68 | 35.12 | 28 | 986 | 20167 | 42600154 |
| Injection site reaction | 80.73 | 35.12 | 25 | 989 | 15696 | 42604625 |
| Chills | 37.83 | 35.12 | 25 | 989 | 94041 | 42526280 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Influenza like illness | 649.39 | 27 | 214 | 4714 | 88198 | 110496173 |
| Multiple sclerosis relapse | 485.19 | 27 | 150 | 4778 | 50090 | 110534281 |
| Injection site erythema | 371.32 | 27 | 144 | 4784 | 94032 | 110490339 |
| Injection site reaction | 152.87 | 27 | 76 | 4852 | 88994 | 110495377 |
| Device malfunction | 100.09 | 27 | 39 | 4889 | 25519 | 110558852 |
| Injection site pruritus | 88.62 | 27 | 44 | 4884 | 51214 | 110533157 |
| Injection site bruising | 74.08 | 27 | 39 | 4889 | 51224 | 110533147 |
| Chills | 74.07 | 27 | 64 | 4864 | 190516 | 110393855 |
| Injection site rash | 68.54 | 27 | 29 | 4899 | 23390 | 110560981 |
| Injection site pain | 59.68 | 27 | 55 | 4873 | 177867 | 110406504 |
| Abortion spontaneous | 57.97 | 27 | 29 | 4899 | 34253 | 110550118 |
| Maternal exposure during pregnancy | 56.56 | 27 | 63 | 4865 | 254820 | 110329551 |
| Drug delivery system malfunction | 49.28 | 27 | 11 | 4917 | 1024 | 110583347 |
| Lymphopenia | 45.42 | 27 | 26 | 4902 | 40144 | 110544227 |
| Injection site swelling | 35.19 | 27 | 26 | 4902 | 61764 | 110522607 |
| Magnetic resonance imaging abnormal | 34.69 | 27 | 11 | 4917 | 3934 | 110580437 |
| Loss of control of legs | 32.06 | 27 | 9 | 4919 | 2123 | 110582248 |
| Product administered to patient of inappropriate age | 30.51 | 27 | 12 | 4916 | 8024 | 110576347 |
| Anal polyp | 30.27 | 27 | 5 | 4923 | 92 | 110584279 |
| Leukopenia | 29.94 | 27 | 35 | 4893 | 148756 | 110435615 |
| Product dose omission issue | 29.47 | 27 | 52 | 4876 | 321730 | 110262641 |
| Paralysis | 28.75 | 27 | 14 | 4914 | 15586 | 110568785 |
| Balance disorder | 27.87 | 27 | 30 | 4898 | 116530 | 110467841 |
| Prolonged labour | 27.77 | 27 | 6 | 4922 | 480 | 110583891 |
| Caesarean section | 27.28 | 27 | 13 | 4915 | 13804 | 110570567 |
| Injection site alopecia | 27.06 | 27 | 3 | 4925 | 0 | 110584371 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L03AB13 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Interferons |
| FDA CS | M0025715 | Interferon-beta |
| FDA EPC | N0000191625 | Interferon beta |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsing remitting multiple sclerosis | indication | 426373005 | DOID:2378 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interferon alpha/beta receptor | Membrane receptor | AGONIST | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| I8309403R0 | UNII |
| 4033770 | VANDF |
| C3848580 | UMLSCUI |
| CHEBI:753625 | CHEBI |
| CHEMBL2108677 | ChEMBL_ID |
| D10483 | KEGG_DRUG |
| DB09122 | DRUGBANK_ID |
| 9661 | INN_ID |
| C428112 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7637 | IUPHAR_LIGAND_ID |
| 1546168 | RXNORM |
| 227899 | MMSL |
| 30489 | MMSL |
| d08282 | MMSL |
| 015648 | NDDF |
| 706897007 | SNOMEDCT_US |
| 714201001 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PlegridyPen | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-011 | INJECTION, SOLUTION | 125 ug | SUBCUTANEOUS | BLA | 27 sections |
| Plegridy | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-015 | INJECTION, SOLUTION | 125 ug | SUBCUTANEOUS | BLA | 27 sections |
| Plegridy | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64406-017 | INJECTION, SOLUTION | 125 ug | INTRAMUSCULAR | BLA | 27 sections |