Altoprev

ALTOPREV- lovastatin tablet, extended release
Covis Pharma

1 INDICATIONS AND USAGE

Therapy with lipid-altering agents should be one component of multiple risk factor intervention in individuals who require modifications of their lipid profile. Drug therapy is recommended as an adjunct to a diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate.

1.1 Prevention of Coronary Heart Disease

In patients without symptomatic coronary heart disease (CHD), but at high risk, Altoprev® is indicated to reduce the risk of:

Myocardial infarction
Unstable angina
Coronary revascularization procedures

Coronary Heart Disease

Altoprev® is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower Total-C and LDL-C to target levels.

1.2 Hyperlipidemia

Altoprev® is indicated as an adjunct to diet for the reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb).

1.3 Limitations of Use

Altoprev® has not been studied in Fredrickson Types I, III, and V.

2 DOSAGE AND ADMINISTRATION

2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The recommended dosing range is 20-60 mg/day, in single doses taken in the evening at bedtime.

2.2 Elderly Patients

The usual recommended starting dose in elderly patients (age≥65 years) is 20 mg once a day given in the evening at bedtime. Higher doses should be used only after careful consideration of the potential risks and benefits [see Use in Specific Populations (8.5) and Warnings and Precautions (5.1) ].

2.3 Co-administration with Other Drugs

Patients Taking Danazol, Diltiazem, Dronedarone, or Verapamil

The dose of Altoprev should not exceed 20 mg/day [see Warnings and Precautions (5.1) ].

Patients Taking Amiodarone

The dose of Altoprev should not exceed 40 mg/day. [see Warnings and Precautions (5.1) and Drug Interactions (7.6) ].

2.4 Dosage in Patients With Renal Impairment

In patients with severe renal impairment (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should only be considered if the expected benefit exceeds the increased risk of myopathy/rhabdomyolysis. [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

3 DOSAGE FORMS AND STRENGTHS

Altoprev® (lovastatin extended-release) tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.

4 CONTRAINDICATIONS

The use of Altoprev® is contraindicated in the following conditions:

Concomitant administration of strong CYP3A inhibitors [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ].
Concomitant administration of erythromycin [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ].
Hypersensitivity to any component of this product [see Adverse Reactions (6.1) ].
Active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions ( 5.3) ].
Pregnancy. [see Use in Specific Populations (8.1) ].
Lactation. Because another drug in this class passes into breast milk, and because statins have the potential to cause serious adverse reactions in breastfed infants, women who require Altoprev® treatment should not breastfeed their infants. [see Use in Specific Populations ( 8.2) ].

5 WARNINGS AND PRECAUTIONS

5.1 Skeletal Muscle Effects

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Altoprev®. These risks can occur at any dose level, but increase in a dose-dependent manner. Predisposing factors for myopathy include advanced age (≥65 years), female gender, renal impairment, and inadequately treated hypothyroidism. 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.

All patients starting therapy with Altoprev® , or whose dose of Altoprev® is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, 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 Altoprev. Altoprev therapy should be discontinued immediately if myopathy is diagnosed or suspected.

Altoprev® therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Altoprev® 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; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled epilepsy.

Drug Interactions that Can Cause Skeletal Muscle Effects

Strong CYP3A Inhibitors: The risk of myopathy and rhabdomyolysis is increased by high levels of statin activity in plasma. Lovastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of lovastatin and may increase the risk of myopathy. Co-administration of these drugs with Altoprev is contraindicated. If treatment with strong CYP3A inhibitors is unavoidable, therapy with Altoprev should be suspended during the course of treatment [see Contraindications (4); Clinical Pharmacology (12.3); Drug Interactions (7.1)].

Erythromycin: Co-administration of erythromycin with Altoprev is contraindicated. If treatment with erythromycin is unavoidable, therapy with Altoprev should be suspended during the course of treatment [see Contraindications (4); Drug Interactions (7.2)].

Gemfibrozil:Avoid the combined use of Altoprev with gemfibrozil.

Other lipid-lowering drugs (other fibrates, or lipid-lowering doses (≥ 1 g/day) of niacin: Use caution when prescribing other fibrates or lipid-lowering doses (≥ 1 g/day) of niacin with Altoprev, as these agents can cause myopathy when given alone and the risk is increased when they are coadministered with Altoprev. Carefully weigh the expected benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin against the potential risks of these combinations [see Drug Interactions (7.3) ].

Cyclosporine:Avoid the combined use of Altoprev with cyclosporine [see Drug Interactions (7.4) ].

Danazol, diltiazem, dronedarone or verapamil with higher doses of lovastatin:Do not exceed 20 mg of Altoprev daily in patients receiving concomitant therapy with danazol, diltiazem, dronedarone or verapamil. Weigh carefully the benefits of the use of Altoprev in patients receiving danazol, diltiazem, dronedarone or verapamil against the risks of these combinations [see Drug Interactions (7.6) ].

Amiodarone: Do not exceed 40 mg of Altoprev daily in patients receiving concomitant therapy with amiodarone. Avoid the combined use of Altoprev at doses exceeding 40 mg daily with amiodarone unless the clinical benefit is likely to outweigh the increased risk of myopathy. The concomitant use of higher doses of a closely related member of the HMG-CoA reductase inhibitor class with amiodarone increased the risk of myopathy/rhabdomyolysis [see Drug Interactions (7.6) ].

Colchicine:There have been cases of myopathy, including rhabdomyolysis, reported in patients receiving lovastatin coadministered with colchicine. Use caution when prescribing Altoprev with colchicine [see Drug Interactions (7.9) ].

Ranolazine:Concomitant use of ranolazine and Altoprev may increase the risk of myopathy, including rhabdomyolysis. Consider dose adjustment of Altoprev if coadministering with ranolazine [see Drug Interactions (7.9) ].

Prescribing recommendations for interacting agents are summarized in Table 1.

Table 1 Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis

Interacting Agents

Prescribing Recommendations

Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin,HIV protease inhibitors, boceprevir, telaprevir, and nefazodone), Erythromycin

Contraindicated with lovastatin

GemfibrozilCyclosporine

Avoid with lovastatin

DanazolDiltiazemDronedaroneVerapamil

Do not exceed 20 mg lovastatin daily

Amiodarone

Do not exceed 40 mg lovastatin daily

Grapefruit juice

Avoid grapefruit juice

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