Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Tablets and Pravastatin

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.

Paritaprevir may significantly increase the blood levels of pravastatin. 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. Talk to your doctor if you have any questions or concerns. 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 while taking pravastatin 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 ombitasvir/paritaprevir/ritonavir plus dasabuvir may significantly increase the plasma concentrations of pravastatin. The mechanism may involve inhibition of OATP1B1-mediated hepatic uptake of pravastatin by both paritaprevir and ritonavir. In 12 study subjects, administration of pravastatin 10 mg once daily in combination with once daily morning doses of ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg) plus twice daily doses of dasabuvir resulted in increases of approximately 37% and 82% in mean pravastatin peak plasma concentration (Cmax) and systemic exposure (AUC), 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. Pravastatin had no significant effect on the pharmacokinetics of ombitasvir, paritaprevir, ritonavir, and dasabuvir.

MANAGEMENT: The benefits of using pravastatin with ombitasvir/paritaprevir/ritonavir plus dasabuvir should be carefully weighed against the potentially increased risk of myopathy including rhabdomyolysis. If coadministration is required, the lowest effective dosage of pravastatin should be used and close monitoring for musculoskeletal toxicity is recommended. The dosage of pravastatin should be limited to 40 mg/day. Alternatively, an interruption of pravastatin may be considered during treatment with ombitasvir/paritaprevir/ritonavir plus dasabuvir, or a different HMG-CoA reductase inhibitor such as fluvastatin or pitavastatin may be substituted. 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.

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Tablets

Generic Name: dasabuvir / ombitasvir / paritaprevir / ritonavir

Brand name: Viekira XR, Viekira Pak

Synonyms: Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Extended-Release Tablets, and Dasabuvir

What is Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Tablets?

Pravastatin

Generic Name: pravastatin

Brand name: Pravachol

Synonyms: n.a.

What is Pravastatin?