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Baycol and Elbasvir and grazoprevir

Determining the interaction of Baycol and Elbasvir and grazoprevir and the possibility of their joint administration.

Check result:
Baycol <> Elbasvir and grazoprevir
Relevance: 03.06.2022 Reviewer: Shkutko P.M., M.D., in

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.

Consumer:

Grazoprevir may significantly increase the blood levels of cerivastatin. 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 already be aware of the risks, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness during treatment with cerivastatin 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.

Professional:

ADJUST DOSE: Coadministration with elbasvir-grazoprevir may significantly increase the plasma concentrations of HMG-CoA reductase inhibitors (statins) that are substrates of the CYP450 3A4 isoenzyme and/or breast cancer resistance protein (BCRP) transporter. Grazoprevir is reported to be a relatively weak inhibitor of CYP450 3A4 in vivo, and both elbasvir and grazoprevir are inhibitors of BCRP at the intestinal level in humans. In 16 study subjects, administration of a single 10 mg dose of atorvastatin (CYP450 3A4 substrate) during treatment with elbasvir-grazoprevir 50 mg-200 mg once daily increased atorvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) by 4.3- and 1.9-fold, respectively, compared to administration of atorvastatin alone. Likewise, when a single 10 mg dose of rosuvastatin (BCRP substrate) was coadministered with elbasvir-grazoprevir in 12 study subjects, rosuvastatin Cmax and AUC increased by 5.5- and 2.3-fold, respectively. High levels of statin or 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 fluvastatin, lovastatin and simvastatin, but similar interactions with elbasvir-grazoprevir should be expected. The pharmacokinetics of elbasvir and grazoprevir were not significantly affected by either atorvastatin or rosuvastatin.

MANAGEMENT: Caution is advised when statins such as atorvastatin, rosuvastatin, fluvastatin, lovastatin, and simvastatin are prescribed with elbasvir-grazoprevir. Atorvastatin dosage should not exceed 20 mg/day and rosuvastatin dosage should not exceed 10 mg/day according to the product labeling for elbasvir-grazoprevir. The lowest effective dose of fluvastatin, lovastatin, or simvastatin should be used; some authorities recommend a maximum daily dose of 20 mg of these statins. In contrast, pitavastatin and pravastatin do not have clinically relevant interactions with elbasvir-grazoprevir, and no dosage adjustments are necessary. 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.

References
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • Cerner Multum, Inc. "Australian Product Information." O 0
  • "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Company Inc, Whitehouse Station, NJ.
Baycol

Generic Name: cerivastatin

Brand name: Baycol

Synonyms: n.a.

Elbasvir and grazoprevir

Generic Name: elbasvir / grazoprevir

Brand name: Zepatier

Synonyms: Elbasvir and Grazoprevir

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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