Hemlibra
E821686
Hemlibra is a monoclonal antibody medication used to prevent or reduce bleeding episodes in people with hemophilia A, including those with factor VIII inhibitors.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Hemlibra canonical | 1 |
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
hemophilia A treatment
ⓘ
medication ⓘ monoclonal antibody ⓘ |
| hasAdministrationFrequency |
every four weeks
ⓘ
every two weeks ⓘ once weekly ⓘ |
| hasAdministrationSetting | can be self-administered after training ⓘ |
| hasApprovalYear | 2017 ⓘ |
| hasATCCode | B02BX06 ⓘ |
| hasBispecificity |
factor IXa-binding
ⓘ
factor X-binding ⓘ |
| hasBlackBoxWarning |
thromboembolism risk when used with activated prothrombin complex concentrate
ⓘ
thrombotic microangiopathy risk when used with activated prothrombin complex concentrate ⓘ |
| hasCommonAdverseEffect |
arthralgia
ⓘ
fever ⓘ headache ⓘ injection site reaction ⓘ |
| hasDosageForm | solution for injection ⓘ |
| hasDrugClass | bispecific monoclonal antibody ⓘ |
| hasFDALabelIndication |
routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors
ⓘ
routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A without factor VIII inhibitors ⓘ |
| hasGenericName | emicizumab ⓘ |
| hasIndication |
hemophilia A
ⓘ
hemophilia A with factor VIII inhibitors ⓘ hemophilia A without factor VIII inhibitors ⓘ prevention of bleeding episodes ⓘ reduction of bleeding episodes ⓘ |
| hasINN | emicizumab ⓘ |
| hasMechanismOfAction |
bridges activated factor IX and factor X
ⓘ
mimics the cofactor function of activated factor VIII ⓘ |
| hasMolecularType | humanized monoclonal antibody ⓘ |
| hasPregnancyCategory | use only if potential benefit justifies potential risk ⓘ |
| hasRegulatoryStatus | prescription only ⓘ |
| hasRouteOfAdministration | subcutaneous ⓘ |
| hasStorageCondition |
protect from light
ⓘ
refrigerated ⓘ |
| hasTarget |
factor IXa
ⓘ
factor X NERFINISHED ⓘ |
| isApprovedBy |
EMA
NERFINISHED
ⓘ
FDA NERFINISHED ⓘ |
| isDevelopedBy | Chugai Pharmaceutical NERFINISHED ⓘ |
| isManufacturedBy | Roche NERFINISHED ⓘ |
| isMarketedBy | Genentech NERFINISHED ⓘ |
| isNotIndicatedFor |
acquired hemophilia A
ⓘ
hemophilia B ⓘ |
| isUsedIn |
adults
ⓘ
children ⓘ infants ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.