Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:monoclonal_antibody
|
| gptkbp:administered_by |
subcutaneous injection
|
| gptkbp:approves |
gptkb:2017
gptkb:FDA |
| gptkbp:availability |
available in specialty pharmacies
|
| gptkbp:clinical_trial |
Phase III
HAVEN 1 HAVEN 2 HAVEN 3 HAVEN 4 |
| gptkbp:clinical_use |
prevent bleeding in patients with hemophilia A
|
| gptkbp:contraindication |
hypersensitivity to emicizumab
|
| gptkbp:developed_by |
gptkb:Roche
|
| gptkbp:dosage_form |
gptkb:Software_Solutions
|
| gptkbp:effective_date |
gptkb:2017
|
| gptkbp:formulation |
lyophilized powder
|
| gptkbp:frequency |
once every week or once every two weeks
|
| https://www.w3.org/2000/01/rdf-schema#label |
Emicizumab
|
| gptkbp:indication |
prophylaxis of bleeding episodes
|
| gptkbp:is_compared_to |
compared to traditional factor replacement therapy
|
| gptkbp:is_monitored_by |
requires regular monitoring of factor levels
|
| gptkbp:lifespan |
30 days
|
| gptkbp:marketed_as |
gptkb:European_Union
gptkb:Japan gptkb:United_States |
| gptkbp:mechanism_of_action |
bispecific antibody
bridges factor IXa and factor X |
| gptkbp:patient_education |
requires patient education on administration
|
| gptkbp:patient_population |
children and adults
|
| gptkbp:pharmacokinetics |
linear pharmacokinetics
factor VIII mimetic activity |
| gptkbp:price |
high cost
|
| gptkbp:recommissioned |
with sterile water
|
| gptkbp:regulatory_compliance |
approved for use in multiple countries
|
| gptkbp:research |
ongoing studies for other bleeding disorders
|
| gptkbp:rounds |
renal
|
| gptkbp:safety_features |
generally well tolerated
|
| gptkbp:side_effect |
headache
nausea thrombosis injection site reactions serious allergic reactions thrombotic microangiopathy improves quality of life for patients |
| gptkbp:storage |
refrigerated
|
| gptkbp:targets |
gptkb:factor_X
gptkb:factor_IXa |
| gptkbp:trade |
gptkb:Hemlibra
|
| gptkbp:type_of_care |
improved adherence compared to factor VIII
|
| gptkbp:used_for |
gptkb:hemophilia_A
|
| gptkbp:bfsParent |
gptkb:Genentech
|
| gptkbp:bfsLayer |
4
|