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Drug Interactions between Baycol and Trilipix

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

cerivastatin fenofibric acid

Applies to: Baycol (cerivastatin) and Trilipix (fenofibric acid)

MONITOR CLOSELY: Data from observational studies suggest that the risk of severe myopathy and rhabdomyolysis is increased when fibric acid derivatives are coadministered with an HMG-CoA reductase inhibitor (i.e., statin), even in the absence of a marked pharmacokinetic interaction. Additive pharmacodynamic effects may be involved, since these agents individually have been associated with the development of myopathy. Although gemfibrozil has been implicated most often, presumably due to a pharmacokinetic interaction with statins that significantly increases their concentrations in plasma, other fibrates have also been involved. In clinical trials for delayed-release fenofibric acid, myalgia was reported in 3.3% of patients receiving monotherapy and 3.1% to 3.5% of patients receiving concomitant statin therapy, compared to 4.7% to 6.1% of patients receiving statin monotherapy. Increases in creatine phosphokinase (CPK) to greater than 5 times upper limit of normal occurred in no patients receiving fenofibric acid monotherapy and 0.2% to 1.2% of patients receiving concomitant statin therapy, compared to 0.4% to 1.3% of patients receiving statin monotherapy. Addition of a fibrate to HMG-CoA reductase inhibitor therapy typically provides little additional reduction in LDL cholesterol, but further reductions of triglycerides and increases in HDL cholesterol may be attained.

MANAGEMENT: Caution is advised if delayed-release fenofibric acid is coadministered with a statin. A lower dosage of the statin may be appropriate, particularly if the patient is already receiving the maximum dosage. Coadministration with the maximum dosage of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks. All patients treated with HMG-CoA reductase inhibitors and/or fibrates should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed. In addition, patients should be closely monitored for hepatotoxicity.

References

  1. Unal A, Torun E, Sipahioglu MH, et al. "Fenofibrate-induced acute renal failure due to massive rhabdomyolysis after coadministration of statin in two patients." Intern Med 47 (2008): 1017-9
  2. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical (2008):

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Drug and food interactions

Moderate

cerivastatin food

Applies to: Baycol (cerivastatin)

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of atorvastatin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. When a single 40 mg dose of atorvastatin was coadministered with 240 mL of grapefruit juice, atorvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 16% and 37%, respectively. Greater increases in Cmax (up to 71%) and/or AUC (up to 2.5 fold) have been reported with excessive consumption of grapefruit juice (>=750 mL to 1.2 liters per day). Clinically, 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.

ADJUST DOSING INTERVAL: Fibres such as oat bran and pectin may diminish the pharmacologic effects of HMG-CoA reductase inhibitors by interfering with their absorption from the gastrointestinal tract.

MANAGEMENT: Patients receiving therapy with atorvastatin should limit their consumption of grapefruit juice to no more than 1 liter per day. Patients 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. In addition, patients should either refrain from the use of oat bran and pectin or, if concurrent use cannot be avoided, to separate the administration times by at least 2 to 4 hours.

References

  1. Richter WO, Jacob BG, Schwandt P "Interaction between fibre and lovastatin." Lancet 338 (1991): 706
  2. McMillan K "Considerations in the formulary selection of hydroxymethylglutaryl coenzyme a reductase inhibitors." Am J Health Syst Pharm 53 (1996): 2206-14
  3. "Product Information. Lipitor (atorvastatin)." Parke-Davis PROD (2001):
  4. Boberg M, Angerbauer R, Fey P, Kanhai WK, Karl W, Kern A, Ploschke J, Radtke M "Metabolism of cerivastatin by human liver microsomes in vitro. Characterization of primary metabolic pathways and of cytochrome P45 isozymes involved." Drug Metab Dispos 25 (1997): 321-31
  5. Bailey DG, Malcolm J, Arnold O, Spence JD "Grapefruit juice-drug interactions." Br J Clin Pharmacol 46 (1998): 101-10
  6. Lilja JJ, Kivisto KT, Neuvonen PJ "Grapefruit juice increases serum concentrations of atorvastatin and has no effect on pravastatin." Clin Pharmacol Ther 66 (1999): 118-27
  7. Neuvonen PJ, Backman JT, Niemi M "Pharmacokinetic comparison of the potential over-the-counter statins simvastatin, lovastatin, fluvastatin and pravastatin." Clin Pharmacokinet 47 (2008): 463-74
View all 7 references

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

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