Statements (63)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:affects |
potential for long-term remission
|
| gptkbp:approves |
gptkb:2022
gptkb:FDA gptkb:U._S._Food_and_Drug_Administration |
| gptkbp:availability |
available through specialty pharmacies
|
| gptkbp:class |
gptkb:monoclonal_antibody
|
| gptkbp:clinical_trial |
Phase 3
Provention Bio, Inc. TN-10 study multiple sites in the U. S. reduced risk of developing type 1 diabetes |
| gptkbp:clinical_use |
used in early intervention for type 1 diabetes
|
| gptkbp:collaboration |
collaborated with academic institutions
|
| gptkbp:contraindication |
hypersensitivity to teplizumab
|
| gptkbp:developed_by |
gptkb:Provention_Bio
|
| gptkbp:dosage_form |
solution for infusion
|
| gptkbp:drug_interactions |
immunosuppressants
|
| gptkbp:duration |
14 days
|
| gptkbp:education_material |
patient brochures available
|
| gptkbp:effective_date |
gptkb:2022
|
| gptkbp:financial_support |
support programs available
|
| gptkbp:funding |
funded by NIH
|
| gptkbp:future_prospects |
ongoing studies for other autoimmune conditions
|
| gptkbp:healthcare |
requires prescription from a healthcare provider
|
| https://www.w3.org/2000/01/rdf-schema#label |
Tzield
|
| gptkbp:indication |
delay onset of stage 3 type 1 diabetes
|
| gptkbp:ingredients |
teplizumab
|
| gptkbp:invention |
patented
|
| gptkbp:is_monitored_by |
requires monitoring for side effects
|
| gptkbp:launch_date |
gptkb:2023
|
| gptkbp:manufacturer |
gptkb:Provention_Bio
Provention Bio, Inc. |
| gptkbp:marketed_as |
gptkb:brand
|
| gptkbp:mechanism_of_action |
immunomodulation
|
| gptkbp:patient_criteria |
specific eligibility criteria for trials
|
| gptkbp:patient_education |
important for managing expectations
|
| gptkbp:patient_population |
individuals at high risk for type 1 diabetes
|
| gptkbp:pharmacokinetics |
half-life of approximately 12 hours
inhibits T-cell activation |
| gptkbp:price |
high cost of treatment
|
| gptkbp:provides_guidance_on |
included in diabetes management guidelines
|
| gptkbp:public_awareness |
increased awareness of type 1 diabetes treatment options
|
| gptkbp:publication |
published in medical journals
|
| gptkbp:regulatory_compliance |
FDA approved
|
| gptkbp:requires |
available on FDA website
|
| gptkbp:research_focus |
autoimmune diseases
|
| gptkbp:route_of_administration |
intravenous
|
| gptkbp:safety_features |
generally well tolerated
|
| gptkbp:service_frequency |
once daily for 14 days
|
| gptkbp:side_effect |
headache
nausea fever vomiting rash increased risk of infections infusion-related reactions |
| gptkbp:storage |
refrigerated
|
| gptkbp:supply_chain |
managed through specialty distribution channels
|
| gptkbp:target_audience |
children and adults
|
| gptkbp:treatment |
improved beta-cell function
|
| gptkbp:type_of_insurance |
may vary by plan
|
| gptkbp:used_for |
treatment of type 1 diabetes
|