Lynavoy (linerixibat)

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Linerixibat inhibits cytochrome P-450 (CYP) 3A4, but does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 isoenzymes. Linerixibat does not induce CYP1A2, CYP2B6, and CYP3A4.

Linerixibat does not inhibit P-glycoprotein (P-gp), breast cancer resistance protein (BRCP), organic anion transporters (OAT) 1 and 3, organic cation transporter (OCT) 2, and multidrug and toxin extrusion protein (MATE) 1 and 2K. Linerixibat may inhibit organic anion transporter polypeptide 1B1 and IB3 (OATP1B1 and OATP1B3).

Linerixibat is minimally absorbed; therefore, clinically significant interactions are unlikely.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Ileal Bile Acid Transporter Inhibitors/Bile Acid Sequestrant

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Bile acid sequestrants may bind to linerixibat, maralixibat and odevixibat in the gut, resulting in decreased absorption of the IBAT inhibitor.(1-3)

CLINICAL EFFECTS: Coadministration of bile acid sequestrants with IBAT inhibitors may cause reduced efficacy of IBAT inhibitors.(1-3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturers state to administer bile acid sequestrants (cholestyramine, colesevelam, and colestipol) at least 4 hours before or 4 hours after administration of IBAT inhibitors.(1-3)

DISCUSSION: Bile acid sequestrants are known to bind to drugs when given concurrently. Administration with IBAT inhibitors may result in decreased systemic absorption.(1-3)

*None.

There are no contraindication contraindications for this drug.

• Pregnancy

• Increased risk of bleeding
• Malabsorption states
• Osteopenia
• Osteoporosis

The most common adverse reactions (>=5%) reported with linerixibat were diarrhea, abdominal pain, nausea, increased ALT, hemorrhage, increased AST, headache, dyspepsia, gastroesophageal reflux disease, abdominal distension, dizziness, and arthralgia.

More Frequent

• Abnormal hepatic function tests
• Hemorrhage

Less Frequent

• Hyperbilirubinemia

More Frequent

• Abdominal distension
• Acute abdominal pain
• Arthralgia
• Diarrhea
• Dizziness
• Dyspepsia
• Gastroesophageal reflux disease
• Headache disorder
• Nausea

Less Frequent

• Hypertriglyceridemia
• Urinary tract infection
• Xerostomia

Rare or Very Rare

• Malabsorption states

No enhanced messaging available.

The safety and efficacy of linerixibat have not been established in pediatric patients.

Data on linerixibat use in pregnancy are insufficient to determine whether there are any drug-associated risks of major defects, miscarriage, or adverse maternal or fetal outcomes. Low fetal exposure is expected as there is minimal systemic absorption with linerixibat following oral administration. Linerixibat may inhibit the absorption of fat-soluble vitamins. Monitor pregnant patients for fat-soluble vitamin deficiency and supplement as needed. If a pregnant women receives linerixibat, report exposure to a pregnancy safety study by contacting GlaxoSmithKline at 1-888-825-5249.

There are no data on the presence of linerixibat in human milk, its effects on the breastfed infant, or its effects on milk production; however, clinically relevant infant exposure through breast milk is expected to be minimal due to poor oral bioavailability following administration of linerixibat. Monitor maternal fat-soluble vitamin levels and increase intake of fat-soluble vitamins if a deficiency is observed during lactation. The benefits of breastfeeding should be weighed against the need for linerixibat and any potential risks to the infant.

There are no specific dosage recommendations for geriatric patients.

Of the 119 patients enrolled in a clinical trial of linerixibat, 21% were >=65 years of age and 3% were >=75 years of age. No overall differences in the safety and effectiveness of linerixibat were observed between geriatric and younger patients; however, greater sensitivity of some older patients cannot be ruled out. There was an insufficient number of patients >=75 years of age to determine if these patients respond differently from younger patients.