Livalo and Olysio

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 pitavastatin together with simeprevir. Combining these medications may significantly increase the blood levels of pitavastatin. This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness during treatment with pitavastatin or similar medications, especially if these symptoms are accompanied by fever or dark colored urine. You should also seek immediate medical attention if you develop fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. 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.

ADJUST DOSE: Coadministration with simeprevir may increase the plasma concentrations of various statins. The proposed mechanism is simeprevir inhibition of OATP1B1-mediated hepatic uptake and/or CYP450 3A4-mediated intestinal metabolism of the affected statins. In 18 healthy study subjects, administration of a single 40 mg dose of atorvastatin in combination with simeprevir 150 mg once daily for 10 days increased mean atorvastatin peak plasma concentration (Cmax) by approximately 1.7-fold and systemic exposure (AUC) by 2.1-fold compared to atorvastatin administered alone. In addition, mean Cmax and AUC of 2-hydroxyatorvastatin increased by approximately 2.0- and 2.3-fold, respectively. Likewise, simeprevir 150 mg once daily for 7 days increased the mean Cmax of a single 10 mg dose of rosuvastatin by approximately 3.2-fold and systemic exposure (AUC) by 2.8-fold in 16 healthy study subjects. When a single 40 mg dose of simvastatin was given with simeprevir 150 mg once daily for 10 days to 18 healthy volunteers, mean Cmax and AUC of simvastatin increased by 46% and 51%, respectively, while Cmax and AUC of simvastatin acid increased by 3.0- and 1.9-fold, respectively. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death. No data are available for lovastatin, pitavastatin and pravastatin, although they are known substrates of OATP1B1 and/or CYP450 3A4.

MANAGEMENT: The lowest dosage of affected statins should be used when prescribed in combination with simeprevir, and the dosage titrated cautiously. Alternatively, fluvastatin may be substituted, as it has been shown to have no significant interaction with simeprevir. All patients receiving statin therapy should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.

Livalo

Generic Name: pitavastatin

Brand name: Livalo, Zypitamag

Synonyms: n.a.

What is Livalo?

Olysio

Generic Name: simeprevir

Brand name: Olysio

Synonyms: n.a.

What is Olysio?