Fenofibrate interactions

Conditions

Conditions in which Fenofibrate needs care, as documented in this source.

• Cholelithiasis

  Major

  The use of fibric acid derivatives is contraindicated in patients with gallbladder disease. A significantly increased incidence of cholelithiasis has been observed in patients treated with the fibric acid derivative, clofibrate, presumably because of increased cholesterol excretion into the bile. Based on two separate studies (the WHO study and the Coronary Drug Project study), clofibrate use was associated with twice the risk of developing cholelithiasis and cholecystitis requiring surgery. Due to their structural and pharmacologic similarities, use of other fibric acid derivatives may be expected to carry the same risk.

  7 sources

  1. "Product Information. Lopid (gemfibrozil)." Parke-Davis (2002):
  2. Blane GF "Comparative toxicity and safety profile of fenofibrate and other fibric acid derivatives." Am J Med 83 (1987): 26-36
  3. Roberts WC "Safety of fenofibrate--US and worldwide experience." Cardiology 76 (1989): 169-79
  4. "Product Information. Atromid-S (clofibrate)." Wyeth-Ayerst Laboratories (2001):
  5. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):
  6. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical (2008):
  7. "Product Information. Fibricor (fenofibric acid)." AR Scientific Inc (2009):

• Hypolipoproteinemias

  Major

  There have been reports of severe decreases in HDL cholesterol (HDL-C) levels (as low as 2 mg/dL) occurring in diabetic and non-diabetic patients initiated on fibric acid derivatives therapy. The decrease has been reported to occur within 2 weeks to years after initiation of therapy. It is recommended that HDL-C levels be checked within the first few months after initiation therapy and if a severely depressed HDL-C level is detected, therapy with these agents should be withdrawn. Monitor HDL-C level until it has returned to baseline, and therapy with these agents should not be re-initiated in these patients.

  4 sources

  1. "Product Information. Lopid (gemfibrozil)." Parke-Davis (2002):
  2. Thompson CH, Irish A, Kemp GJ, Taylor DJ, Radda GK "Skeletal muscle metabolism before and after gemfibrozil treatment in dialysed patients with chronic renal failure." Clin Nephrol 45 (1996): 386-9
  3. Gorriz JL, Sancho A, Lopezmartin JM, Alcoy E, Catalan C, Pallardo LM "Rhabdomyolysis and acute renal failure associated with gemfibrozil therapy." Nephron 74 (1996): 437-8
  4. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):

• Kidney Diseases

  Major

  The use of fibric acid derivatives is contraindicated in patients with significantly impaired renal function. The rate of clearance of fenofibric acid has been shown to decrease substantially when CrCl is below 50 mL/min, with drug accumulation during chronic dosing. Increased adverse effects, including rhabdomyolysis (with or without secondary renal failure) and severe hyperkalemia, have been associated with the use of fibric acid derivatives in patients with renal insufficiency. Therapy with these agents should be administered cautiously in patients with mild or moderate renal impairment. Close clinical monitoring is recommended during therapy.

  12 sources

  1. Pokroy N, Ress S, Gregory MC "Clofibrate-induced complications in renal disease: a case report." S Afr Med J 52 (1977): 806-8
  2. Goldman JA, Fishman AB, Lee JE, Johnson RJ "The role of cholesterol-lowering agents in drug-induced rhabdomyolysis and polymyositis ." Arthritis Rheum 32 (1989): 358-9
  3. Chapman MJ "Pharmacology of fenofibrate." Am J Med 83 (1987): 21-5
  4. Weil A, Caldwell J, Strolin-Benedetti M "The metabolism and disposition of 14C-fenofibrate in human volunteers." Drug Metab Dispos 18 (1990): 115-20
  5. Balfour JA, McTavish D, Heel RC "Fenofibrate. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in dyslipidaemia." Drugs 40 (1990): 260-90
  6. Dealava E, Sola JJ, Lozano MD, Pardomindan FJ "Rhabdomyolysis and acute renal failure in a heart transplant recipient treated with hypolipemiants." Nephron 66 (1994): 242-3
  7. Thompson CH, Irish A, Kemp GJ, Taylor DJ, Radda GK "Skeletal muscle metabolism before and after gemfibrozil treatment in dialysed patients with chronic renal failure." Clin Nephrol 45 (1996): 386-9
  8. Gorriz JL, Sancho A, Lopezmartin JM, Alcoy E, Catalan C, Pallardo LM "Rhabdomyolysis and acute renal failure associated with gemfibrozil therapy." Nephron 74 (1996): 437-8

  Show all 12 sourcesShow fewer sources

  9. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):
  10. Miller DB, Spence JD "Clinical pharmacokinetics of fibric acid derivatives (fibrates)." Clin Pharmacokinet 34 (1998): 155-62
  11. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical (2008):
  12. "Product Information. Fibricor (fenofibric acid)." AR Scientific Inc (2009):

• Liver Cirrhosis, Biliary

  Major

  The use of fibric acid derivatives is contraindicated in patients with primary biliary cirrhosis. These agents may further raise the already elevated cholesterol in these patients.

  5 sources

  1. "Product Information. Lopid (gemfibrozil)." Parke-Davis (2002):
  2. "Product Information. Atromid-S (clofibrate)." Wyeth-Ayerst Laboratories (2001):
  3. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):
  4. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical (2008):
  5. "Product Information. Fibricor (fenofibric acid)." AR Scientific Inc (2009):

• Liver Diseases

  Major

  The use of fibric acid derivatives is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. Fibric acid derivatives therapy is associated with dose-related hepatotoxicity, including biochemical abnormalities of liver function, hepatitis (hepatocellular, chronic active, as well as cholestatic) and, rarely, cirrhosis. Postmarketing cases of severe drug-induced liver injury, including liver transplantation and death, have been reported. Therapy with these agents should be administered cautiously in patients with a history of liver disease and/or heavy alcohol use. Liver function tests, including serum transaminase levels and total bilirubin, should be performed at baseline and periodically throughout the duration of therapy. Therapy should be discontinued if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST greater than 3 times the upper limit of normal, or if accompanied by elevation of bilirubin). Do not restart therapy if there is no alternative explanation for the liver injury.

  9 sources

  1. Cayen MN "Disposition, metabolism and pharmacokinetics of antihyperlipidemic agents in laboratory animals and man." Pharmacol Ther 29 (1985): 157-204
  2. Chapman MJ "Pharmacology of fenofibrate." Am J Med 83 (1987): 21-5
  3. Weil A, Caldwell J, Strolin-Benedetti M "The metabolism and disposition of 14C-fenofibrate in human volunteers." Drug Metab Dispos 18 (1990): 115-20
  4. Balfour JA, McTavish D, Heel RC "Fenofibrate. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in dyslipidaemia." Drugs 40 (1990): 260-90
  5. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):
  6. Adkins JC, Faulds D "Micronised fenofibrate: a review of its pharmacodynamic properties and clinical efficacy in the management of dyslipidaemia." Drugs 54 (1997): 615-33
  7. Miller DB, Spence JD "Clinical pharmacokinetics of fibric acid derivatives (fibrates)." Clin Pharmacokinet 34 (1998): 155-62
  8. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical (2008):

  Show all 9 sourcesShow fewer sources

  9. "Product Information. Fibricor (fenofibric acid)." AR Scientific Inc (2009):

• Rhabdomyolysis

  Major

  Severe myopathy, including rhabdomyolysis with acute renal failure secondary to myoglobinuria, has been reported rarely with the use of fibric acid derivatives. The myopathy may be dose-related and is characterized by muscle aches and/or weakness in conjunction with increases in creatine phosphokinase (CPK) values exceeding 10 times the upper limit of normal. Therapy with fibric acid derivatives should be administered cautiously in patients with preexisting myopathy or a myoneural disorder, since it may delay the recognition or confound the diagnosis of a drug-induced musculoskeletal effect. Patients should be advised to report promptly any unusual muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Periodic CPK determinations may be considered in some patients, although the value of such monitoring is uncertain. Therapy should be withdrawn if markedly elevated CPK levels occur or if drug-related myopathy is diagnosed or suspected.

  23 sources

  1. Pokroy N, Ress S, Gregory MC "Clofibrate-induced complications in renal disease: a case report." S Afr Med J 52 (1977): 806-8
  2. Abourizk N, Khalil BA, Bahuth N, Afifi AK "Clofibrate-induced muscular syndrome. Report of a case with clinical, electromyographic and pathologic observations." J Neurol Sci 42 (1979): 1-9
  3. Rush P, Baron M, Kapusta M "Clofibrate myopathy: a case report and a review of the literature." Semin Arthritis Rheum 15 (1986): 226-9
  4. Goldman JA, Fishman AB, Lee JE, Johnson RJ "The role of cholesterol-lowering agents in drug-induced rhabdomyolysis and polymyositis ." Arthritis Rheum 32 (1989): 358-9
  5. Fusella J, Strosberg JM "Polymyositis exacerbated by gemfibrozil ." J Rheumatol 17 (1990): 572-3
  6. Pierce LR, Wysowski DK, Gross TP "Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy." JAMA 264 (1990): 71-5
  7. Chow LT, Chow WH "Acute compartment syndrome: an unusual presentation of gemfibrozil induced myositis." Med J Aust 158 (1993): 48-9
  8. "Product Information. Lopid (gemfibrozil)." Parke-Davis (2002):

  Show all 23 sourcesShow fewer sources

  9. Blane GF "Comparative toxicity and safety profile of fenofibrate and other fibric acid derivatives." Am J Med 83 (1987): 26-36
  10. Roberts WC "Safety of fenofibrate--US and worldwide experience." Cardiology 76 (1989): 169-79
  11. Dealava E, Sola JJ, Lozano MD, Pardomindan FJ "Rhabdomyolysis and acute renal failure in a heart transplant recipient treated with hypolipemiants." Nephron 66 (1994): 242-3
  12. Shepherd J "Fibrates and statins in the treatment of hyperlipidaemia: an appraisal of their efficacy and safety." Eur Heart J 16 (1995): 5-13
  13. Thompson CH, Irish A, Kemp GJ, Taylor DJ, Radda GK "Skeletal muscle metabolism before and after gemfibrozil treatment in dialysed patients with chronic renal failure." Clin Nephrol 45 (1996): 386-9
  14. "Product Information. Atromid-S (clofibrate)." Wyeth-Ayerst Laboratories (2001):
  15. Gorriz JL, Sancho A, Lopezmartin JM, Alcoy E, Catalan C, Pallardo LM "Rhabdomyolysis and acute renal failure associated with gemfibrozil therapy." Nephron 74 (1996): 437-8
  16. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):
  17. Duell PB, Connor WE, Illingworth DR "Rhabdomyolysis after taking atorvastatin with gemfibrozil." Am J Cardiol 81 (1998): 368-9
  18. Kirchgassler KU, Schmitz H, Bach G "Effectiveness and tolerability of 12-week treatment with micronised fenofibrate 200mg in a drug-monitoring programme involving 9884 patients with dyslipidaemia." Clin Drug Invest 15 (1998): 197-204
  19. Iliadis EA, Rosenson RS "Long-term safety of pravastatin-gemfibrozil therapy in mixed hyperlipidemia." Clin Cardiol 22 (1999): 25-8
  20. van Puijenbroek EP, Du Buf-Vereijken PW, Spooren PF, van Doormaal JJ "Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil." J Intern Med 240 (1996): 403-4
  21. Pogson GW, Kindred LH, Carper BG "Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy." Am J Cardiol 83 (1999): 1146
  22. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical (2008):
  23. "Product Information. Fibricor (fenofibric acid)." AR Scientific Inc (2009):

• Hematologic Diseases

  Moderate

  Mild to moderate hemoglobin, hematocrit and white blood cell decreases have been observed in patients following initiation of fibric acid derivatives therapy. However, these levels stabilize during long-term administration. Thrombocytopenia and agranulocytosis have been reported in individuals treated with these agents. Caution is recommended when treating patients predisposed to hematologic changes. Periodic monitoring of red and white blood cell counts is recommended during the first 12 months of therapy.

  4 sources

  1. "Product Information. Lopid (gemfibrozil)." Parke-Davis (2002):
  2. Thompson CH, Irish A, Kemp GJ, Taylor DJ, Radda GK "Skeletal muscle metabolism before and after gemfibrozil treatment in dialysed patients with chronic renal failure." Clin Nephrol 45 (1996): 386-9
  3. Gorriz JL, Sancho A, Lopezmartin JM, Alcoy E, Catalan C, Pallardo LM "Rhabdomyolysis and acute renal failure associated with gemfibrozil therapy." Nephron 74 (1996): 437-8
  4. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):