Overview
Indications
® OCALIVAis indicated for the treatment of adult patients with primary biliary cholangitis (PBC) either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. Clinical Studies (14) [see] This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication ma
Boxed Warning
FDA Black Box Warning
Warnings and Precautions (5.1) [see] Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis. Contraindications (4) [see]. OCALIVA
Contraindications
When this intervention should not be used
OCALIVA is contraindicated in patients with: Warnings and Precautions (5.1) [see] decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event. Warnings and Precautions (5.1) [see] compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophag
Indications & Related Conditions
Conditions associated via SNOMED clinical relationships
Administration & Protocol
Dosing, route, and treatment protocol
Detailed dosage and administration information is available in the full FDA drug label.
View full prescribing information on DailyMedMonitoring & Follow-Up
Biomarkers relevant to this intervention via related conditions
No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.
Clinical Trials
2 trials linked to this intervention
Research Evidence
Published studies and systematic reviews
Research data from MEDLINE/PubMed
Benefits & Expected Outcomes
Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.
Risks & Side Effects
Adverse reaction and safety data for this drug is sourced from the FDA-approved label.
View adverse reactions & drug interactions on DailyMedRelated Symptoms
Symptoms associated with conditions this intervention addresses
No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.
Alternatives & Comparisons
Alternative treatments, comparison data, and clinical decision support are pending physician authorship.
This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.
Do not start, stop, or change any treatment without consulting your healthcare provider.
Quick Facts
- Type
- Substance / Medication
- Fully Specified Name
- Obeticholic acid (substance)
- SNOMED CT
- 720257002
- UMLS CUI
- C1143018
- RxNorm CUI
- 1798288
- Labeler
- Intercept Pharmaceuticals Inc
Clinical Data
This intervention maps to 1 entities in the Ltrl knowledge graph.
Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.