Seladelpar

Seladelpar is a prescription medication indicated for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy if unable to tolerate UDCA.

• Seladelpar is available under the following different brand names: Livdelzi.

Common side effects of Seladelpar include:

• headache
• stomach (abdominal) pain
• nausea
• abdominal swelling (distension)
• dizziness

Serious side effects of Seladelpar include:

• bone fractures
• changes in liver test symptoms include swelling of the stomach area (abdomen) from a build-up of fluid
• yellowing of the skin or the whites of the eyes, mental changes such as confusion, being sleepier than usual or harder to wake up, pain on the right side of the stomach slurred speech, mood swings, or changes (abdomen) in personality, black, tarry, or bloody stools, coughing up or vomiting blood, or the vomit looks like “coffee grounds”

Rare side effects of Seladelpar include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 10 mg

Primary biliary cholangitis

Adult dosage

• 10 mg orally once daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Seladelpar has no noted severe interactions with any other drugs
• Seladelpar has no noted serious interactions with any other drugs
• Seladelpar has no noted moderate interactions with any other drugs
• Seladelpar has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Seladelpar?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Seladelpar?”

Cautions

• Fractures
  • Fractures can occur
  • Consider fracture risk and monitor bone health according to current standards of care
• Liver test abnormalities
  • Associated with dose-related increases in serum transaminase (AST, ALT) with doses more than 10 mg/day
  • Obtain baseline clinical and laboratory assessments (i.e., liver function tests [LFTs]) at treatment initiation and monitor after that according to routine patient management
  • Interrupt treatment if LFTs worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia)
  • Consider permanent discontinuation if LFTs worsen after restarting
• Biliary obstruction
  • Avoid use with complete biliary obstruction
  • If biliary obstruction is suspected, interrupt dosing and treat as clinically indicated
• Drug interaction overview
  • Coadministration with OAT3 inhibitors
    • Avoid
  • OAT3 inhibitors may increase seladelpar exposure
  • Coadministration with strong CYP2C9 inhibitors
    • Avoid
  • Strong CYP2C9 inhibitors may increase seladelpar exposure
    • Coadministration with bile acid sequestrants
    • Modify dose
• Bile acid sequestrants may reduce seladelpar absorption and systemic exposure, which may reduce efficacy
• Administer seladelpar at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as greatest possible interval
• Coadministration with rifampin
  • Monitor
  • Rifampin may reduce seladelpar exposure; monitor the biochemical response (e.g., ALP, bilirubin) of seladelpar if initiating rifampin during treatment
• Coadministration with dual CYP2C9 and CYP3A4 inhibitors
  • Monitor
• Medications that are both a moderate CYP2C9 inhibitor and a moderate-to-strong CYP3A4 inhibitor may increase seladelpar exposure
• CYP2C9 poor metabolizers using moderate-to-strong CYP3A4 inhibitors
  • Monitor
  • Coadministration of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9-poor metabolizers may increase seladelpar exposure
• Coadministration with BCRP inhibitors
  • Monitor
  • BCRP inhibitors may increase seladelpar exposure

Pregnancy and Lactation

• Data from human pregnancies exposed to seladelpar are insufficient 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
  • Data are unavailable regarding the presence of seladelpar or its metabolite in either human or animal milk, its effects on breastfed infants, or milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy with potential adverse effects in a breastfed child or from the underlying maternal condition