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Uses
Side effects
Interactions
Precautions
Altoprev® is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
• Reduce the risk of MI, revascularization procedures, and angina in patients without CHD, but with multiple risk factors. (1.1)
• Slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower Total-C and LDL-C. (1.1)
• Reduce elevated Total-C, LDL-C, Apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) Limitations of Use Altoprev® has not been studied in Fredrickson Types I, III, and V dyslipidemias. (1.3)
- The most commonly reported adverse reactions (incidence ≥ 5%) in patients treated with Altoprev® in placebo-controlled trials were: infection, headache and accidental injury. (6.1)
- Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis (2.3 5.1, 7, 12.3) Interacting Agents Prescribing Recommendations Strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone), Erythromycin Contraindicated with lovastatin Gemfibrozil, cyclosporine Avoid with lovastatin Danazol, diltiazem, dronedarone, verapamil
- Do not exceed 20 mg lovastatin daily Amiodarone
- Do not exceed 40 mg lovastatin daily
- Grapefruit juice Avoid grapefruit juice
- Other Lipid-Lowering Medications: Use with other fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with Altoprev®. (7)
- Skeletal muscle effects (e.g., myopathy and rhabdomyolysis) Predisposing factors include advanced age (≥ 65), female gender, uncontrolled hypothyroidism, and renal impairment.
- Advise patients to report promptly to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness.
- Altoprev therapy should be discontinued immediately if myopathy is diagnosed or suspected. (5.1)
- Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.2)
