See the DrugPatentWatch profile for Ocaliva
What is Ocaliva, and what is it FDA-approved to treat?
Ocaliva is the brand name for obeticholic acid (OCA). The FDA has approved it for primary biliary cholangitis (PBC) in specific patient groups, including people with an inadequate response to ursodeoxycholic acid (UDCA) or those who cannot tolerate UDCA. [1]
How is Ocaliva taken (FDA label basics)?
The FDA-approved dosing is once daily and depends on the patient’s liver function. Dose adjustments may be needed, and some patients are started at a lower dose due to hepatic impairment. [2]
What side effects are most associated with Ocaliva?
A key safety issue highlighted by the FDA label is pruritus (itching), which can be significant in some patients. Ocaliva can also be associated with other adverse reactions listed in the prescribing information, and monitoring may be required based on the individual’s liver status. [2]
What monitoring does FDA labeling recommend?
Because Ocaliva affects liver-related pathways, clinicians typically monitor liver tests and assess the patient’s response to therapy over time, consistent with the prescribing information. Patients may also be monitored for tolerability (for example, worsening itching). [2]
Who makes Ocaliva and where does FDA documentation show up?
Ocaliva is an FDA-reviewed drug product with prescribing information and approvals accessible through FDA resources and the drug’s official label. [1][2]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] https://www.accessdata.fda.gov/scripts/cder/daf/