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Pharmacologic class: HMG-CoA reductase inhibitor
Therapeutic class: Antihyperlipidemic
Pregnancy risk category X
Increases rate at which body removes cholesterol from blood and reduces production of cholesterol by inhibiting enzyme that catalyzes early rate-limiting step in cholesterol synthesis
Tablets: 1 mg, 2 mg, 4 mg
⊘Indications and dosages
➣ Primary hyperlipidemia, mixed dyslipidemia
Adults: 2 mg P.O. daily; may increase to maximum of 4 mg daily
• Renal impairment
• Patient with end-stage renal disease on dialysis
• Concurrent use of erythromycin or rifampin
• Hypersensitivity to drug or its components
• Active liver disease, unexplained persistent transaminase elevations
• Concurrent use of cyclosporine
• Women of childbearing age
Use cautiously in:
• patients with severe renal impairment not on dialysis (use not recommended)
• patients with predisposing factors for myopathy (such as untreated hypothyroidism)
• patients who consume substantial quantities of alcohol or have history of chronic liver disease
• concurrent use of protease inhibitors (such as lopinavir, ritonavir), erythromycin, fibric acids (such as fenofibrate, gemfibrozil), rifampin, or niacin
• elderly patients
• children (safety and efficacy not established).
• Check liver function tests before starting therapy.
• Administer with or without food.
GI: diarrhea, constipation
Hepatic: liver enzyme abnormalities
Musculoskeletal: arthralgia, myalgia, back pain, extremity pain, rhabdomyolysis
Skin: rash, pruritus, urticaria
Other: influenza, hypersensitivity
Drug-drug.Cyclosporine, erythromycin, fibric acids, niacin, protease inhibitors, rifampin: increased pitavastatin effect and risk of myopathy
Drug-diagnostic tests.Alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, blood glucose, creatine kinase: increased levels
Drug-food.Grapefruit juice: increased drug area under the curve
☞ Discontinue drug if markedly elevated creatine kinase level occurs or myopathy is diagnosed or suspected.
☞ Temporarily withhold drug if an acute serious condition suggests myopathy or predisposes to development of renal failure secondary to rhabdomyolysis (such as sepsis, hypotension, dehydration, major surgery, trauma, uncontrolled seizures, or severe metabolic, endocrine, and electrolyte disorders).
• Analyze lipid levels 4 weeks after starting therapy and after dosage titration; monitor liver enzyme levels 12 weeks after starting therapy, after dosage titration, and periodically thereafter. Should an increase in ALT or AST level of more than three times the upper limit of normal persist, dosage reduction or drug withdrawal is recommended. Continue to monitor patient who develops increased transaminase levels until abnormalities resolve.
• In patient receiving warfarin concurrently, closely monitor prothrombin time and International Normalized Ratio.
• Tell patient to take drug with or without food.
☞ Instruct patient to immediately report to prescriber if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by malaise or fever.
• Caution patient to avoid or decrease alcohol intake.
• Advise breastfeeding patient not to breastfeed while taking drug.
• Advise female patient of childbearing age to use an effective method of birth control to prevent pregnancy while using drug and if she becomes pregnant, advise her to stop taking drug and notify prescriber.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and food mentioned above.
ClassificationTherapeutic: lipid lowering agents
Pharmacologic: hmg coa reductase inhibitors
Time/action profile (effect on lipids)
|PO||within 4 wk||4 wk||unknown|
Adverse Reactions/Side Effects
Central nervous system
- memory loss
- constipation (most frequent)
- diarrhea (most frequent)
- ↑ liver enzymes
- rhabdomyolysis (life-threatening)
- myositis (most frequent)
- back pain (most frequent)
- extremity pain (most frequent)
- myalgia (most frequent)
- immune-mediated necrotizing myopathy
- hypersensitivity reactions
Drug-Drug interactionCyclosporine ↑ levels and the risk for myopathy; concurrent use contraindicated.Risk of myopathy is ↑ by concurrent use of erythromycin, rifampin, fibrates, colchicine or large doses of niacin ; use ↓ doses with erythromycin, rifampin, and niacin; concurrent use with gemfibrozil should be avoided.Alcohol may ↑ risk of liver toxicity.
Renal ImpairmentOral (Adults) CCr <60 mL/min—1 mg once daily initially, may be ↑ up to 2 mg daily.
- Obtain a diet history, especially with regard to fat consumption.
- Lab Test Considerations: Evaluate serum cholesterol and triglyceride levels before initiating, after 4 wk of therapy, and periodically thereafter.
- Monitor liver function tests prior to initiation of therapy and as clinically indicated. If symptoms of serious liver injury, hyperbilirubinemia, or jaundice occurs, discontinue pitavastatin and do not restart. May also cause ↑ alkaline phosphatase and bilirubin levels.
- If patient develops muscle tenderness during therapy, CK levels should be monitored. If CK levels are markedly elevated or myopathy occurs, therapy should be discontinued.
Potential Nursing DiagnosesNoncompliance (Patient/Family Teaching)
- Oral: May be administered at any time of the day without regard to food.
- Instruct patient to take medication exactly as directed, not to skip doses or double up on missed doses. Medication helps control but does not cure elevated serum cholesterol levels.
- Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
- Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
- Advise women of child bearing age to use effective contraception during therapy and discuss plans to discontinue pitavastatin if trying to conceive. Instruct female patients to notify health care professional promptly if pregnancy is suspected. Advise patients to avoid breastfeeding during therapy.
- Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.
- Decrease in LDL, apolipoprotein, and total cholesterol levels.
- Increase in HDL cholesterol levels.
- Decrease in triglyceride levels.