4 simple steps to access LIVDELZI
Send the prescription to one of the specialty pharmacies or the specialty distributor belowa:
aThe list of authorized distributors is updated periodically and is subject to change. Please visit gilead.com/purpose/medication-access/
authorized-distributors for updates.
Consider adding LIVDELZI to your EMR/EHR Favorites List to facilitate prescribing once you’ve determined LIVDELZI is appropriate for your patients.
The specialty pharmacy will:
- Explain insurance coverage
- Assist with prior authorization
- Confirm cost and financial assistance optionsb
The specialty pharmacy will call your patient to schedule delivery.
Advise your patients to look out for the specialty pharmacy’s call, check voicemails, and save the specialty pharmacy’s phone number in their contacts. The call may come from a number they don’t recognize.
When it’s time for a refill, the specialty pharmacy will call your patient.
bIf additional support is required for your office staff or patient, you can request a Field Reimbursement Manager (FRM) or connect with Support Path®.
cData from 09/2024 through 06/2026.1
dInsured patients include commercial, Medicare, and Medicaid patients. Data from 09/2024 through 06/2026.1
EHR=electronic health record; EMR=electronic medical record.
Tap for Important Safety Information, including warnings for fractures, liver test abnormalities, and biliary obstruction
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Limitation of Use: Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (eg, ascites, variceal bleeding, hepatic encephalopathy).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care.
- Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels >3x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI.
- Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated.
Adverse Reactions
- The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%).
Drug Interactions
Potential Increased Exposure of LIVDELZI with:
- Probenecid: Avoid coadministration with LIVDELZI.
- Strong CYP2C9 Inhibitors: Monitor for adverse effects during concomitant use.
- Dual Moderate CYP2C9 and Moderate or Strong CYP3A4 Inhibitors (eg, fluconazole): Monitor for adverse effects during concomitant use.
- CYP2C9 Poor Metabolizers Using Moderate or Strong CYP3A4 Inhibitors: Monitor for adverse effects during concomitant use of a moderate or strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers.
- Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP (eg, cyclosporine): Monitor for adverse effects during concomitant use.
Potential Reduction in LIVDELZI Exposure with:
- Rifampin: Concomitant use of LIVDELZI with rifampin, an inducer of metabolizing enzymes, may result in delayed or suboptimal LIVDELZI biochemical response. Monitor biochemical response (eg, ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment.
- Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.
Pregnancy and Lactation
- Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235.
- Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI.
Please see full Prescribing Information for LIVDELZI.
Reference
- Data on file. Gilead Sciences, Inc.; 2026.