Juxtapid Capsules and Tolvaptan (Jynarque/Jinarc)

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Talk to your doctor before using lomitapide together with tolvaptan. Lomitapide may cause liver problems, and taking it with other medications that can also affect the liver such as tolvaptan may increase that risk. You should avoid or limit the use of alcohol to no more than one drink per day while being treated with these medications. Call your doctor immediately if you have fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark colored urine, light colored stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. In addition, lomitapide may increase the blood levels and effects of tolvaptan. Serious nervous system side effects such as difficulty swallowing, trouble speaking, muscle weakness, trouble controlling body movements, confusion, mood changes, seizures, and coma may occur. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

MONITOR CLOSELY: Coadministration of lomitapide with other agents known to induce hepatotoxicity such as tolvaptan may potentiate the risk of liver injury. Lomitapide can cause elevations in serum transaminases and hepatic steatosis. In a premarketing clinical trial, 34% (10/29) of patients treated with lomitapide had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of normal (ULN) or greater, and 14% (4/29) had at least one elevation in ALT or AST 5 times ULN or greater. There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase. Lomitapide also increases hepatic fat, with or without concomitant increases in transaminases. In the same study, the median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with lomitapide may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis. Clinical data suggest that hepatic fat accumulation is reversible after stopping treatment with lomitapide, although the long-term consequences are unknown.

MANAGEMENT: Caution is advised if lomitapide is prescribed in combination with other potentially hepatotoxic agents such as tolvaptan. Patients should have serum ALT, AST, alkaline phosphatase, and total bilirubin measured prior to initiation of treatment and regularly during treatment in accordance with the product labeling, and the dosing adjusted or interrupted as necessary. Since alcohol may increase levels of hepatic fat and induce or exacerbate liver injury, the manufacturer recommends that patients taking lomitapide not consume more than one alcoholic drink per day. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.

ADJUST DOSE: Coadministration with inhibitors of CYP450 3A4 and/or P-glycoprotein (P-gp) may increase the oral bioavailability of tolvaptan, which has been shown to be a substrate of the isoenzyme as well as the efflux transporter. Since lomitapide is an inhibitor of both CYP450 3A4 and P-gp, a pharmacokinetic interaction is possible, although the interaction has not been studied or reported.

MANAGEMENT: Serum sodium concentration and neurologic status should be closely monitored, and the tolvaptan dosage adjusted accordingly. Too rapid correction of hyponatremia increases the risk of osmotic demyelination syndrome, which is associated with dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death. Discontinuation or interruption of tolvaptan therapy should be considered in patients who develop too rapid a rise in serum sodium.

Juxtapid Capsules

Generic Name: lomitapide

Brand name: Juxtapid

Synonyms: Lomitapide

What is Juxtapid Capsules?

Tolvaptan (Jynarque/Jinarc)

Generic Name: tolvaptan

Brand name: Samsca, Jynarque

Synonyms: Tolvaptan

What is Tolvaptan (Jynarque/Jinarc)?