DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

LOVASTATIN

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIR concern

Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

CLINICAL PHARMACOLOGY
The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma. Strong inhibitors of CYP3A4 can raise the plasma levels of HMG-CoA reductase inhibitory activity and increase the risk of myopathy (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS and PRECAUTIONS, DRUG INTERACTIONS).
CONTRAINDICATIONS
Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS).
WARNINGS
Myopathy/Rhabdomyolysis
Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.
As with other HMG-CoA reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose related. In a clinical study (EXCEL) in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4933 patients randomized to lovastatin 20–40 mg daily for 48 weeks, and 4 among 1649 patients randomized to 80 mg daily.
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
All patients starting therapy with lovastatin, or whose dose of lovastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing lovastatin. Lovastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected. In most cases, muscle symptoms and CK increases resolved when treatment was promptly discontinued. Periodic CK determinations may be considered in patients starting therapy with lovastatin or whose dose is being increased, but there is no assurance that such monitoring will prevent myopathy.
Many of the patients who have developed rhabdomyolysis on therapy with lovastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients merit closer monitoring. Lovastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Lovastatin therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.
The risk of myopathy/rhabdomyolysis is increased by concomitant use of lovastatin with the following:
- Strong inhibitors of CYP3A4: Lovastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of cytochrome P450 3A4 (CYP3A4). Certain drugs which inhibit this metabolic pathway can raise the plasma levels of lovastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, posaconazole, voriconazole, the macrolide antibiotics erythromycin and clarithromycin, the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, or the antidepressant nefazodone. Combination of these drugs with lovastatin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with lovastatin should be suspended during the course of treatment (see CONTRAINDICATIONS; PRECAUTIONS, DRUG INTERACTIONS).
- Gemfibrozil: The combined use of lovastatin with gemfibrozil should be avoided.
- Other lipid-lowering drugs (other fibrates or ≥1 g/day of niacin): Caution should be used when prescribing other fibrates or lipid-lowering doses (≥1 g/day) of niacin with lovastatin, as these agents can cause myopathy when given alone. The benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin should be carefully weighed against the potential risks of these combinations.
- Cyclosporine: The use of lovastatin with cyclosporine should be avoided.
- Danazol, diltiazem, dronedarone, or verapamil with higher doses of lovastatin: The dose of lovastatin should not exceed 20 mg daily in patients receiving concomitant medication with danazol, diltiazem, dronedarone, or verapamil. The benefits of the use of lovastatin in patients receiving danazol, diltiazem, dronedarone, or verapamil should be carefully weighed against the risks of these combinations.
- Amiodarone: The dose of lovastatin should not exceed 40 mg daily in patients receiving concomitant medication with amiodarone. The combined use of lovastatin at doses higher than 40 mg daily with amiodarone should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy. The risk of myopathy/rhabdomyolysis is increased when amiodarone is used concomitantly with higher doses of a closely related member of the HMG-CoA reductase inhibitor class.
- Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with lovastatin coadministered with colchicine, and caution should be exercised when prescribing lovastatin with colchicine (see PRECAUTIONS, DRUG INTERACTIONS).
- Ranolazine: The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine. Dose adjustment of lovastatin may be considered during coadministration with ranolazine.
Prescribing recommendations for interacting agents are summarized in Table VII (see also CLINICAL PHARMACOLOGY, PHARMACOKINETICS; PRECAUTIONS, DRUG INTERACTIONS; DOSAGE AND ADMINISTRATION).
PRECAUTIONS
Information for Patients
Patients should be advised about substances they should not take concomitantly with lovastatin and be advised to report promptly unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing lovastatin (see list below and WARNINGS, MYOPATHY/RHABDOMYOLYSIS). Patients should also be advised to inform other physicians prescribing a new medication that they are taking lovastatin.
Drug Interactions
CYP3A4 Interactions
Lovastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Strong inhibitors of CYP3A4 (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, and erythromycin), and grapefruit juice increase the risk of myopathy by reducing the elimination of lovastatin. (See CONTRAINDICATIONS, WARNINGS, MYOPATHY/RHABDOMYOLYSIS, and CLINICAL PHARMACOLOGY, PHARMACOKINETICS.)
Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone
The risk of myopathy is also increased by the following lipid-lowering drugs that are not strong CYP3A4 inhibitors, but which can cause myopathy when given alone.
See WARNINGS, MYOPATHY/RHABDOMYOLYSIS.
Other Drug Interactions
Cyclosporine: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS).
Danazol, Diltiazem, Dronedarone, or Verapamil: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol, diltiazem, dronedarone, or verapamil particularly with higher doses of lovastatin (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS; CLINICAL PHARMACOLOGY, PHARMACOKINETICS).
Amiodarone: The risk of myopathy/rhabdomyolysis is increased when amiodarone is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS).
Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with lovastatin coadministered with colchicine. See WARNINGS, MYOPATHY/RHABDOMYOLYSIS.
Ranolazine: The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine. See WARNINGS, MYOPATHY/RHABDOMYOLYSIS.
ADVERSE REACTIONS
In Phase III controlled clinical studies involving 613 patients treated with lovastatin, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study (see EXPANDED CLINICAL EVALUATION OF LOVASTATIN [EXCEL] STUDY).
Persistent increases of serum transaminases have been noted (see WARNINGS, LIVER DYSFUNCTION). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 percent. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS).
Concomitant Therapy
In controlled clinical studies in which lovastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with lovastatin or cholestyramine. Other lipid-lowering agents were not administered concomitantly with lovastatin during controlled clinical studies. Preliminary data suggests that the addition of gemfibrozil to therapy with lovastatin is not associated with greater reduction in LDL-C than that achieved with lovastatin alone. In uncontrolled clinical studies, most of the patients who have developed myopathy were receiving concomitant therapy with cyclosporine, gemfibrozil or niacin (nicotinic acid). The combined use of lovastatin with cyclosporine or gemfibrozil should be avoided. Caution should be used when prescribing other fibrates or lipid-lowering doses (≥1 g/day) of niacin with lovastatin (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS).
The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with lovastatin therapy.
Skeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS).
DOSAGE AND ADMINISTRATION
Adult Patients
The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10–80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP GUIDELINES and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.
Dosage in Patients taking Danazol, Diltiazem, Dronedarone, or Verapamil
In patients taking danazol, diltiazem, dronedarone, or verapamil concomitantly with lovastatin, therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day (see CLINICAL PHARMACOLOGY, PHARMACOKINETICS, WARNINGS, MYOPATHY/RHABDOMYOLYSIS, PRECAUTIONS, DRUG INTERACTIONS, OTHER DRUG INTERACTIONS).
Dosage in Patients taking Amiodarone
In patients taking amiodarone concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS and PRECAUTIONS, DRUG INTERACTIONS, OTHER DRUG INTERACTIONS).
Concomitant Lipid-Lowering Therapy
Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS, MYOPATHY/RHABDOMYOLYSIS and PRECAUTIONS, DRUG INTERACTIONS).
Dosage in Patients with Renal Insufficiency
In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, MYOPATHY/RHABDOMYOLYSIS).

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

226

42686

Other ADRs

1449

14115830

Odds Ratio = 51.578

Drug Property Information

ATC Code(s):

C10BA01 - lovastatin

C10BA - HMG CoA reductase inhibitors in combination with other lipid modifying agents
C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

C10AA02 - lovastatin

C10AA - HMG CoA reductase inhibitors
C10A - "LIPID MODIFYING AGENTS, PLAIN"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

Active Ingredient:lovastatin

Active Ingredient UNII:9LHU78OQFD

Drugbank ID:DB00227

PubChem Compound:53232

CAS Number:75330-75-5

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

45.0 mg/day C10AA02

Chemical Structure:

SMILE Code:
CC[C@H](C)C(=O)O[C@H]1C[C@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@@H]3C[C@H](CC(=O)O3)O)C

Reference

COHORT STUDY:

N/A

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167: Rhabdomyolysis and renal injury with lovastatin use. Report of two cases in cardiac transplant recipients.

[Corpier C L,Jones P H,Suki W N,Lederer E D,Quinones M A,Schmidt S W,Young J B]
JAMA.1988 Jul 8;260(2):239-41. PMID: 3290520

168: Rhabdomyolysis in patients receiving lovastatin after cardiac transplantation.

[East C,Alivizatos P A,Grundy S M,Jones P H,Farmer J A]
N Engl J Med.1988 Jan 7;318(1):47-8. PMID: 3275892

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