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| Stem definition | Drug id | CAS RN |
|---|---|---|
| human origin | 5315 | 1655501-53-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
|
| Dose | Unit | Route |
|---|---|---|
| 7.50 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 23, 2021 | PMDA | OTSUKA PHARMACEUTICAL Co., Ltd. | |
| Sept. 14, 2018 | FDA | TEVA PHARMS USA | |
| March 28, 2019 | EMA | TEVA GMBH |
| 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 |
|---|---|---|---|---|---|---|
| Injection site erythema | 375.61 | 25.43 | 171 | 6627 | 98331 | 90523318 |
| Accidental exposure to product | 371.82 | 25.43 | 134 | 6664 | 42232 | 90579417 |
| Injection site pruritus | 309.19 | 25.43 | 125 | 6673 | 53709 | 90567940 |
| Injection site rash | 267.74 | 25.43 | 91 | 6707 | 24082 | 90597567 |
| Injection site swelling | 237.60 | 25.43 | 107 | 6691 | 59732 | 90561917 |
| Injection site pain | 223.58 | 25.43 | 147 | 6651 | 173552 | 90448097 |
| Device leakage | 173.66 | 25.43 | 53 | 6745 | 9938 | 90611711 |
| Injection site reaction | 166.80 | 25.43 | 97 | 6701 | 91983 | 90529666 |
| Incorrect dose administered by device | 146.38 | 25.43 | 41 | 6757 | 5696 | 90615953 |
| Device malfunction | 131.66 | 25.43 | 52 | 6746 | 20925 | 90600724 |
| Drug dose omission by device | 111.16 | 25.43 | 38 | 6760 | 10193 | 90611456 |
| Migraine | 109.45 | 25.43 | 100 | 6698 | 190292 | 90431357 |
| Injection site urticaria | 103.82 | 25.43 | 42 | 6756 | 17969 | 90603680 |
| Wrong technique in device usage process | 76.61 | 25.43 | 25 | 6773 | 5810 | 90615839 |
| Needle issue | 71.82 | 25.43 | 30 | 6768 | 13904 | 90607745 |
| Inappropriate schedule of product administration | 69.49 | 25.43 | 70 | 6728 | 149863 | 90471786 |
| Medication overuse headache | 63.44 | 25.43 | 16 | 6782 | 1485 | 90620164 |
| Injection site mass | 61.52 | 25.43 | 31 | 6767 | 22059 | 90599590 |
| Injection site warmth | 59.03 | 25.43 | 28 | 6770 | 17487 | 90604162 |
| Device delivery system issue | 51.30 | 25.43 | 14 | 6784 | 1764 | 90619885 |
| Incorrect dose administered | 48.28 | 25.43 | 43 | 6755 | 78887 | 90542762 |
| Wrong technique in product usage process | 47.82 | 25.43 | 41 | 6757 | 71530 | 90550119 |
| Injection site discharge | 44.55 | 25.43 | 12 | 6786 | 1439 | 90620210 |
| Abortion missed | 40.85 | 25.43 | 12 | 6786 | 1970 | 90619679 |
| Therapeutic response shortened | 38.44 | 25.43 | 23 | 6775 | 22856 | 90598793 |
| Headache | 38.00 | 25.43 | 146 | 6652 | 862600 | 89759049 |
| Device issue | 33.07 | 25.43 | 23 | 6775 | 29514 | 90592135 |
| Pruritus | 32.81 | 25.43 | 102 | 6696 | 541423 | 90080226 |
| Urticaria | 32.38 | 25.43 | 72 | 6726 | 312662 | 90308987 |
| Injection site vesicles | 32.01 | 25.43 | 12 | 6786 | 4188 | 90617461 |
| Constipation | 31.82 | 25.43 | 67 | 6731 | 280328 | 90341321 |
| Status migrainosus | 31.15 | 25.43 | 6 | 6792 | 158 | 90621491 |
| Device difficult to use | 30.44 | 25.43 | 18 | 6780 | 17507 | 90604142 |
| Device defective | 30.40 | 25.43 | 11 | 6787 | 3475 | 90618174 |
| Immediate post-injection reaction | 30.17 | 25.43 | 7 | 6791 | 457 | 90621192 |
| Injection site induration | 30.05 | 25.43 | 15 | 6783 | 10453 | 90611196 |
| Injection site oedema | 29.12 | 25.43 | 9 | 6789 | 1754 | 90619895 |
| Injection site extravasation | 29.11 | 25.43 | 14 | 6784 | 9005 | 90612644 |
| Product storage error | 28.05 | 25.43 | 18 | 6780 | 20223 | 90601426 |
| Product dose omission issue | 26.70 | 25.43 | 64 | 6734 | 291623 | 90330026 |
| Injection site cellulitis | 26.12 | 25.43 | 8 | 6790 | 1513 | 90620136 |
| 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 |
|---|---|---|---|---|---|---|
| Accidental exposure to product | 48.33 | 38.47 | 16 | 603 | 20377 | 42600339 |
| 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 |
|---|---|---|---|---|---|---|
| Injection site erythema | 268.72 | 26.99 | 119 | 5532 | 94057 | 110489591 |
| Injection site pruritus | 267.69 | 26.99 | 100 | 5551 | 51158 | 110532490 |
| Accidental exposure to product | 209.03 | 26.99 | 83 | 5568 | 49925 | 110533723 |
| Injection site swelling | 201.96 | 26.99 | 86 | 5565 | 61704 | 110521944 |
| Injection site rash | 168.58 | 26.99 | 58 | 5593 | 23361 | 110560287 |
| Injection site pain | 137.67 | 26.99 | 95 | 5556 | 177827 | 110405821 |
| Migraine | 106.07 | 26.99 | 80 | 5571 | 171572 | 110412076 |
| Injection site reaction | 96.98 | 26.99 | 59 | 5592 | 89011 | 110494637 |
| Device leakage | 93.56 | 26.99 | 34 | 5617 | 16014 | 110567634 |
| Drug dose omission by device | 78.13 | 26.99 | 29 | 5622 | 14487 | 110569161 |
| Inappropriate schedule of product administration | 74.15 | 26.99 | 70 | 5581 | 203567 | 110380081 |
| Injection site urticaria | 73.32 | 26.99 | 29 | 5622 | 17186 | 110566462 |
| Medication overuse headache | 58.43 | 26.99 | 14 | 5637 | 1549 | 110582099 |
| Wrong technique in device usage process | 53.17 | 26.99 | 18 | 5633 | 6883 | 110576765 |
| Device malfunction | 50.15 | 26.99 | 25 | 5626 | 25533 | 110558115 |
| Abortion missed | 48.44 | 26.99 | 12 | 5639 | 1525 | 110582123 |
| Injection site warmth | 46.32 | 26.99 | 21 | 5630 | 17384 | 110566264 |
| Headache | 45.06 | 26.99 | 122 | 5529 | 882255 | 109701393 |
| Therapeutic response shortened | 43.91 | 26.99 | 24 | 5627 | 29559 | 110554089 |
| Injection site mass | 42.26 | 26.99 | 22 | 5629 | 24591 | 110559057 |
| Pruritus | 38.66 | 26.99 | 89 | 5562 | 581471 | 110002177 |
| Incorrect dose administered by device | 38.08 | 26.99 | 14 | 5637 | 6800 | 110576848 |
| Injection site oedema | 36.70 | 26.99 | 10 | 5641 | 1844 | 110581804 |
| Needle issue | 36.63 | 26.99 | 18 | 5633 | 17822 | 110565826 |
| Injection site bruising | 36.34 | 26.99 | 26 | 5625 | 51237 | 110532411 |
| Device defective | 29.56 | 26.99 | 10 | 5641 | 3812 | 110579836 |
| Injection site discharge | 29.48 | 26.99 | 8 | 5643 | 1452 | 110582196 |
| Injection site vesicles | 28.03 | 26.99 | 10 | 5641 | 4461 | 110579187 |
| Product use issue | 27.99 | 26.99 | 54 | 5597 | 311641 | 110272007 |
| Product storage error | 27.82 | 26.99 | 16 | 5635 | 21712 | 110561936 |
| Immediate post-injection reaction | 27.67 | 26.99 | 6 | 5645 | 425 | 110583223 |
None
| Source | Code | Description |
|---|---|---|
| ATC | N02CD03 | NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists |
| MeSH PA | D000077221 | Calcitonin Gene-Related Peptide Receptor Antagonists |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
| CHEBI has role | CHEBI:35480 | analgesic |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Migraine | indication | 37796009 | DOID:6364 |
| Prevention of migraine attacks | indication | 408381007 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Calcitonin gene-related peptide 1 | GPCR | ANTIBODY BINDING | Kd | 10.30 | IUPHAR | DRUG LABEL |
| ID | Source |
|---|---|
| PF8K38CG54 | UNII |
| 4037844 | VANDF |
| 4037845 | VANDF |
| C4549503 | UMLSCUI |
| CHEBI:757206 | CHEBI |
| CHEMBL4297756 | ChEMBL_ID |
| DB14041 | DRUGBANK_ID |
| D11055 | KEGG_DRUG |
| 10299 | INN_ID |
| C000604315 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9208 | IUPHAR_LIGAND_ID |
| C000605816 | MESH_SUPPLEMENTAL_RECORD_UI |
| 781125008 | SNOMEDCT_US |
| 781150006 | SNOMEDCT_US |
| 289669 | MMSL |
| 34962 | MMSL |
| 34963 | MMSL |
| d08897 | MMSL |
| 017742 | NDDF |
| 2056690 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AJOVY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51759-202 | INJECTION | 225 mg | SUBCUTANEOUS | BLA | 28 sections |
| AJOVY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51759-204 | INJECTION | 225 mg | SUBCUTANEOUS | BLA | 28 sections |