Pitavastatin: Drug information

(For additional information see "Pitavastatin: Patient drug information" and see "Pitavastatin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Special Alerts

Statin Pregnancy Contraindication Update July 2021

After a comprehensive review of all available data, the FDA is requesting all statin manufacturers to remove the contraindication in the prescribing information against using statins in pregnant patients. Although statin therapy should be discontinued in most pregnant patients, health care providers should consider the ongoing therapeutic needs of the individual patient, especially patients at very high risk of cardiovascular events during pregnancy, such as patients with homozygous familial hypercholesterolemia or those with established cardiovascular disease. Additionally, breastfeeding is still not recommended in patients taking a statin; health care providers should determine whether it is better to temporarily stop statin therapy while breastfeeding or to continue statin therapy and not have the patient breastfeed. If ongoing statin treatment is necessary, infant formula and other alternatives are available. The FDA expects that removing the contraindication will enable health care providers and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.

Further information is available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy.

Brand Names: US

Livalo;
Zypitamag

Pharmacologic Category

Antilipemic Agent, HMG-CoA Reductase Inhibitor

Dosing: Adult

Dosage guidance:

Dosing: Pitavastatin 1 to 4 mg/day is considered a moderate-intensity statin (generally reduces low-density lipoprotein cholesterol [LDL-C] by ~30% to 49%). If LDL-C must be lowered ≥50%, select a high-intensity statin (atorvastatin or rosuvastatin). Assess response ~1 to 3 months after therapy initiation or dose adjustment and every 3 to 12 months thereafter (Ref).

Clinical considerations: Use in conjunction with lifestyle modification (eg, diet, exercise). When initiating therapy and selecting dose intensity, consider age, baseline LDL-C, 10-year atherosclerotic cardiovascular disease (ASCVD) risk, risk-enhancing factors, potential adverse effects, and drug interactions (Ref).

Heterozygous familial hypercholesterolemia

Heterozygous familial hypercholesterolemia:

Note: Use of pitavastatin should be limited to patients unable to tolerate a high-intensity statin (atorvastatin or rosuvastatin). Multiple lipid-lowering therapies may be needed if statin monotherapy is not effective. Referral to a lipid specialist should be considered if treatment goals are not met (Ref).

Patients unable to tolerate high-intensity therapy:

Moderate-intensity therapy: Oral: 1 to 4 mg once daily (Ref).

Prevention of atherosclerotic cardiovascular disease

Prevention of atherosclerotic cardiovascular disease (off-label use):

Note: If LDL-C goal (eg, percent reduction or absolute goal) is not met with the initial dose, may consider up-titration to a maximum of 4 mg/day based on estimated 10-year ASCVD risk (see ACC/AHA ASCVD Risk Estimator Plus online), LDL-C response, and tolerability. If LDL-C goal is not met with maximally tolerated dose, consider switching to a high-intensity statin (atorvastatin or rosuvastatin); additional lipid-lowering therapy may be warranted (Ref).

Primary prevention:

Patients without diabetes, age 40 to 75 years, and LDL-C 70 to 189 mg/dL:

ASCVD 10-year risk 5% to <7.5%:

Note: Depending on baseline LDL-C and presence of risk-enhancing factors, consider statin therapy after shared decision-making with patient. Some experts suggest shared decision-making if ASCVD 10-year risk is 5% to 10%; however, in patients with a baseline LDL-C ≥160 mg/dL, statin therapy is usually recommended (Ref).

Moderate-intensity therapy: Oral: 1 to 4 mg once daily to reduce LDL-C by 30% to 49% (Ref).

ASCVD 10-year risk ≥7.5% to <20%:

Note: Depending on baseline LDL-C and presence of risk-enhancing factors, consider statin therapy after shared decision-making with patient. Some experts suggest initiating moderate-intensity statin therapy in most patients if ASCVD 10-year risk is >10% to <20% and LDL-C is >100 mg/dL (Ref).

Moderate-intensity therapy: Oral: 1 to 4 mg once daily to reduce LDL-C by 30% to 49%; higher risk patients with multiple risk-enhancing factors may benefit from high-intensity statin therapy (ie, with atorvastatin or rosuvastatin) to reduce LDL-C by ≥50% (Ref).

ASCVD 10-year risk ≥20% (alternative agent):

Note: Use of pitavastatin should be limited to patients unable to tolerate a high-intensity statin (Ref).

Patients unable to tolerate high-intensity therapy (eg, appropriate dose of atorvastatin or rosuvastatin):

Moderate-intensity therapy: Oral: 1 to 4 mg once daily (Ref).

Patients with diabetes:

Age 40 to 75 years without additional ASCVD risk factors :

Moderate-intensity therapy: Oral: 1 to 4 mg once daily to reduce LDL-C by 30% to 49% (Ref).

ASCVD 10-year risk ≥7.5% or multiple ASCVD risk factors (alternative agent) :

Note: Use of pitavastatin should be limited to patients unable to tolerate a high-intensity statin (Ref).

Patients unable to tolerate high-intensity therapy (eg, appropriate dose of atorvastatin or rosuvastatin):

Moderate-intensity therapy: Oral: 1 to 4 mg once daily (Ref).

Patients with LDL-C ≥190 mg/dL and age 20 to 75 years (regardless of ASCVD risk estimate or coexisting diabetes mellitus) (alternative agent):

Note: Use of pitavastatin should be limited to patients unable to tolerate a high-intensity statin (Ref).

Patients unable to tolerate high-intensity therapy (eg, appropriate dose of atorvastatin or rosuvastatin):

Moderate-intensity therapy: Oral: 1 to 4 mg once daily (Ref).

Secondary prevention in patients with established ASCVD (eg, coronary heart disease, cerebrovascular disease [ischemic stroke or transient ischemic attack], peripheral arterial disease) (alternative agent):

Note: Use of pitavastatin should be limited to patients unable to tolerate a high-intensity statin (Ref). Patients with high-risk ASCVD may require additional therapies to achieve LDL-C goal (eg, <70 mg/dL or <50 mg/dL if very high risk) (Ref).

Patients unable to tolerate high-intensity therapy (eg, appropriate doses of atorvastatin or rosuvastatin):

Moderate-intensity therapy: Oral: 1 to 4 mg once daily (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

GFR ≥60 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer’s labeling.

GFR 15 to 59 mL/minute/1.73 m² (not receiving hemodialysis): Initial: 1 mg once daily; maximum: 2 mg/day

ESRD receiving hemodialysis: Initial: 1 mg once daily; maximum: 2 mg/day

Dosing: Hepatic Impairment: Adult

Contraindicated in active liver disease or decompensated cirrhosis.

Dosing: Adjustment for Toxicity: Adult

Severe muscle symptoms or fatigue: Promptly discontinue use; evaluate CPK, creatinine, and urinalysis for myoglobinuria (Ref).

Mild to moderate muscle symptoms: Discontinue use until symptoms can be evaluated; evaluate patient for conditions that may increase the risk for muscle symptoms (eg, hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases). Upon resolution, resume the original or lower dose of pitavastatin. If muscle symptoms recur, discontinue pitavastatin use. After muscle symptom resolution, may then use a low dose of a different statin; gradually increase if tolerated. In the absence of continued statin use, if muscle symptoms or elevated CPK continues after 2 months, consider other causes of muscle symptoms. If determined to be due to another condition aside from statin use, may resume statin therapy at the original dose (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Pitavastatin: Pediatric drug information")

Dosage guidance:

Dosing: Dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and patient response; adjustments should be made at intervals of 4 weeks.

Clinical considerations: Lifestyle changes are recommended to be implemented for at least 6 to 12 months before beginning pharmacotherapy (Ref).

Heterozygous familial hypercholesterolemia

Heterozygous familial hypercholesterolemia (HeFH): Children ≥8 years and Adolescents: Livalo (pitavastatin calcium): Oral: Initial: 2 mg once daily; evaluate lipids after 4 weeks and titrate dose accordingly; maximum daily dose: 4 mg/day; lipid levels should be evaluated 4 weeks after any dose adjustment.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: Muscle symptoms (potential myopathy): Children ≥8 years and Adolescents: Discontinue use until symptoms can be evaluated; check CPK level; based on experience in adult patients, also evaluate patient for conditions that may increase the risk for muscle symptoms (eg, hypothyroidism; reduced renal or hepatic function; rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases). Upon resolution (symptoms and any associated CPK abnormalities), resume the original dose or consider a lower dose of pitavastatin and retitrate. If muscle symptoms recur, discontinue pitavastatin use. After muscle symptom resolution, may then reinitiate a different statin at an initial low dose; gradually increase if tolerated. Based on experience in adult patients, if muscle symptoms or elevated CPK persists for 2 months in the absence of continued statin use, consider other causes of muscle symptoms. If determined to be due to another condition aside from statin use, may resume statin therapy at the original dose (Ref).

Dosing: Kidney Impairment: Pediatric

Children ≥8 years and Adolescents: Livalo: There are no pediatric-specific recommendations (has not been established); based on experience in adult patients, dosage reductions should be considered.

Dosing: Hepatic Impairment: Pediatric

Children ≥8 years and Adolescents: Livalo: Contraindicated in active liver disease or in patients with unexplained persistent elevations of serum transaminases.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

1% to 10%:

Gastrointestinal: Constipation (4%), diarrhea (3%)

Neuromuscular & skeletal: Back pain (4%), myalgia (2% to 3%)

Frequency not defined:

Infection: Influenza

Nervous system: Headache

Neuromuscular & skeletal: Arthralgia

Respiratory: Nasopharyngitis

Postmarketing:

Cardiovascular: Chest pain (AlZahrani 2019)

Dermatologic: Acute generalized exanthematous pustulosis (Saito-Sasaki 2016)

Endocrine & metabolic: Elevated glycosylated hemoglobin, increased serum glucose

Gastrointestinal: Abdominal distress, abdominal pain, dyspepsia, nausea

Genitourinary: Erectile dysfunction

Hepatic: Hepatic failure, hepatitis, increased serum alkaline phosphatase, increased serum bilirubin, increased serum transaminases, jaundice

Hypersensitivity: Angioedema (Naz 2018), hypersensitivity reaction

Nervous system: Asthenia, depression, dizziness, fatigue, hypoesthesia, insomnia, malaise, peripheral neuropathy

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen, muscle spasm, myopathy, rhabdomyolysis

Respiratory: Interstitial pulmonary disease

Contraindications

Hypersensitivity to pitavastatin or any component of the formulation; active liver disease or decompensated cirrhosis; coadministration with cyclosporine.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Diabetes mellitus: Increases in HbA_1c and fasting blood glucose have been reported; however, the benefits of statin therapy far outweigh the risk of dysglycemia. Optimize lifestyle measures including exercise, maintaining a healthy body weight, and making healthy food choices.

• Hepatotoxicity: Elevations in serum transaminases have been reported; elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy in most cases. Postmarketing reports of fatal and nonfatal hepatic failure have been reported and are rare. If serious hepatotoxicity with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, interrupt therapy promptly. Consider baseline and periodic liver enzyme tests, as clinically indicated. Ethanol may enhance the potential of adverse hepatic effects; instruct patients to avoid excessive ethanol consumption.

• Hypersensitivity: Hypersensitivity reactions, including angioedema, rash, pruritus, and urticaria, have been reported.

• Myopathy/Rhabdomyolysis: Myopathy with CPK >10 times the ULN and rhabdomyolysis (sometimes fatal) with or without acute renal failure secondary to myoglobinuria have been reported; patients should be monitored closely. This risk is dose-related (doses >4 mg) and is increased with concurrent use of colchicine, erythromycin, fibrates, niacin (doses ≥1 g/day), or rifampin. If concurrent use is warranted, consider lower starting and maintenance doses of pitavastatin; use is contraindicated with cyclosporine and not recommended with gemfibrozil. Use caution in patients ≥65 years of age, uncontrolled hypothyroidism, and renal impairment; these patients are predisposed to myopathy. Immune-mediated necrotizing myopathy (IMNM) associated with HMG-CoA reductase inhibitors use has also been reported rarely; discontinue therapy if IMNM is suspected. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing pitavastatin. Temporarily withhold therapy in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, electrolyte disorders; uncontrolled epilepsy). Discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed/suspected; consider treatment with immunosuppressants and additional neuromuscular and serologic testing.

Disease-related concerns:

• Hepatic impairment: Use is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases; use with caution in patients who consume large amounts of ethanol or have a history of liver disease.

• Myasthenia gravis: May rarely worsen or precipitate myasthenia gravis (MG); monitor for worsening MG if treatment is initiated (AAN [Narayanaswami 2021]).

• Renal impairment: Use with caution in patients with renal impairment; these patients are predisposed to myopathy and rhabdomyolysis. Dosage adjustment required in patients with GFR <60 mL/minute/1.73 m² including end-stage renal disease receiving hemodialysis.

Special Populations:

• Older adult: Use with caution in patients ≥65 years of age; these patients are predisposed to myopathy and rhabdomyolysis.

• Surgical patients: The manufacturer recommends temporary discontinuation for elective major surgery, acute medical or surgical conditions, or in any patient experiencing an acute or serious condition predisposing to renal failure (eg, sepsis; shock; severe hypovolemia; trauma; severe metabolic, endocrine, electrolyte disorders; uncontrolled epilepsy). Based on current research and clinical guidelines, HMG-CoA reductase inhibitors should be continued in the perioperative period for noncardiac and cardiac surgery (ACC/AHA [Fleisher 2014]; ACC/AHA [Hillis 2011]). Perioperative discontinuation of statin therapy is associated with an increased risk of cardiac morbidity and mortality.

Other warnings/precautions:

• Appropriate use: The effect on cardiovascular morbidity and mortality has not been determined.

• Hyperlipidemia: Secondary causes of hyperlipidemia should be ruled out prior to therapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as calcium:

Livalo: 1 mg, 2 mg, 4 mg

Generic: 1 mg, 2 mg, 4 mg

Tablet, Oral, as magnesium [strength expressed as base]:

Zypitamag: 1 mg [DSC], 2 mg, 4 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Livalo Oral)

1 mg (per each): $12.79

2 mg (per each): $12.79

4 mg (per each): $12.79

Tablets (Pitavastatin Calcium Oral)

1 mg (per each): $11.50 - $12.15

2 mg (per each): $11.50 - $12.15

4 mg (per each): $11.50 - $12.15

Tablets (Zypitamag Oral)

2 mg (per each): $9.30

4 mg (per each): $9.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer with or without food; may take without regard to time of day.

Administration: Pediatric

Oral: Administer without regard to food or time of day; take at the same time each day.

Use: Labeled Indications

Heterozygous familial hypercholesterolemia (Livalo [pitavastatin calcium] only): As an adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, and apo B in children and adolescents ≥8 years of age.

Heterozygous familial hypercholesterolemia: As an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides, and to increase high-density lipoprotein cholesterol in adults with primary hyperlipidemia.

Use: Off-Label: Adult

Primary and secondary prevention of atherosclerotic cardiovascular disease

Medication Safety Issues

Sound-alike/look-alike issues:

HMG-CoA reductase inhibitors (when referred to as "statins") may be confused with nystatin.

Pitavastatin may be confused with atorvastatin, fluvastatin, lovastatin, nystatin, pravastatin, rosuvastatin, simvastatin

Metabolism/Transport Effects

Substrate of CYP2C8 (minor), CYP2C9 (minor), OATP1B1/1B3 (SLCO1B1/1B3), UGT1A3, UGT2B7; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abiraterone Acetate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Asciminib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Asunaprevir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Bezafibrate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Bezafibrate may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). More specifically, bezafibrate may increase the serum concentration of fluvastatin Management: Avoid use of bezafibrate and HMG-CoA reductase inhibitors (statins) unless strictly indicated due to the increased of muscle toxicity (including rhabdomyolysis). In patients who may be predisposed to myopathy, concomitant use is contraindicated. Risk D: Consider therapy modification

Ciprofibrate: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Management: Avoid the use of HMG-CoA reductase inhibitors and ciprofibrate if possible. If concomitant therapy is considered, benefits should be carefully weighed against the risks, and patients should be monitored closely for signs/symptoms of muscle toxicity. Risk D: Consider therapy modification

Cobicistat: May increase the serum concentration of Pitavastatin. Risk C: Monitor therapy

Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Colchicine. Risk C: Monitor therapy

CycloSPORINE (Systemic): May increase the serum concentration of Pitavastatin. Risk X: Avoid combination

Daclatasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

DAPTOmycin: HMG-CoA Reductase Inhibitors (Statins) may enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping statin (HMG-CoA reductase inhibitor) therapy prior to daptomycin. If daptomycin is used with a statin, creatine phosphokinase (CPK) monitoring could be considered. Risk D: Consider therapy modification

Darolutamide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Eltrombopag: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Encorafenib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Erythromycin (Systemic): May increase the serum concentration of Pitavastatin. Management: Limit pitavastatin to a maximum of 1 mg/day when used in combination with erythromycin. If this combination is used, monitor patients more closely for evidence of pitavastatin toxicity. Risk D: Consider therapy modification

Etravirine: May increase the serum concentration of Pitavastatin. Risk C: Monitor therapy

Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Fostemsavir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest possible starting statin dose and monitor patients closely for statin-related adverse effects (eg, muscle aches and pains) during coadministration with fostemsavir. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for muscle toxicities, including rhabdomyolysis may be significantly increased. Management: Avoid concurrent use whenever possible. Use is listed as contraindicated in product characteristic summaries in several countries, although UK labeling suggests that use could be considered under exceptional circumstances and with close supervision. Risk X: Avoid combination

Gemfibrozil: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk X: Avoid combination

Glecaprevir and Pibrentasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest statin dose possible if combined with glecaprevir/pibrentasvir and monitor for increased statin effects/toxicities. Avoid concomitant use with atorva-, simva-, or lovastatin. Limit rosuvastatin to 10 mg daily and reduce pravastatin dose 50% Risk D: Consider therapy modification

Lanthanum: May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Administer HMG-CoA reductase inhibitors (eg, statins) at least two hours before or after lanthanum. Risk D: Consider therapy modification

Leflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Letermovir: May increase the serum concentration of Pitavastatin. Risk X: Avoid combination

Niacin: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May increase the serum concentration of Pitavastatin. Management: Canadian product labeling recommends use of the lowest pitavastatin dose with this combination. Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk X: Avoid combination

Repaglinide: HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Repaglinide. Risk C: Monitor therapy

RifAMPin: May increase the serum concentration of Pitavastatin. Management: Limit pitavastatin dose to a maximum of 2 mg/day with concurrent rifampin. Risk D: Consider therapy modification

Roxadustat: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Rupatadine: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for increased CPK and/or other muscle toxicities may be increased. Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of Pitavastatin. Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Trabectedin: HMG-CoA Reductase Inhibitors (Statins) may enhance the myopathic (rhabdomyolysis) effect of Trabectedin. Risk C: Monitor therapy

Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification

Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Voxilaprevir: May increase the serum concentration of Pitavastatin. Risk X: Avoid combination

Reproductive Considerations

Adequate contraception is recommended if an HMG-CoA reductase inhibitor (statin) is required in patients who may become pregnant (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]). Patients planning to become pregnant should discuss their lifetime risk of cardiovascular disease, as well as risks and benefits of statin therapy with their health care team (CCS [Pearson 2021]). When appropriate, statins can be discontinued 1 to 2 months prior to conception (AHA/ACC [Grundy 2019]).

When a statin is needed in a patient of reproductive potential, a more hydrophilic option (eg, pravastatin, rosuvastatin) may be preferred to limit placental transfer (CCS [Pearson 2021]).

Pregnancy Considerations

In healthy pregnancies, changes in lipid synthesis occur that are required for normal placental and fetal growth. Low-density lipoprotein cholesterol and triglycerides increase as pregnancy progresses and decline postpartum. HMG-CoA reductase inhibitors (statins) decrease the synthesis of cholesterol and substances derived from cholesterol. Therefore, based on the mechanism of action, in utero exposure may cause fetal harm (Lecarpentier 2012); however, data from available studies have not shown an increased risk of major congenital anomalies following first trimester exposure (Bateman 2015; Chang 2021; Vahedian-Azimi 2021a). Additional data are needed to evaluate other pregnancy outcomes, such as miscarriage (Vahedian-Azimi 2021b).

Because there is potential for fetal harm, statins should be discontinued once pregnancy is recognized (AHA/ACC [Grundy 2019]; Brunham 2018). If lipid-lowering therapy during pregnancy is required, it should be individualized based on the therapeutic needs of the patient, considering the lifetime risk of untreated disease, use of nonstatin therapies, as well as the known risks and benefits of statins. Based on limited data, when a statin is needed in a pregnant patient, a more hydrophilic option (eg, pravastatin, rosuvastatin) may be preferred. Lipophilic statins (eg, atorvastatin, fluvastatin, lovastatin, simvastatin, pitavastatin) may be more likely to cross the placenta and increase the risk of congenital malformations (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]; Lecarpentier 2012).

Additional data are needed to clarify the role of statins for the prevention of atherosclerotic cardiovascular disease in at-risk pregnant patients (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]; Parikh 2021).

Breastfeeding Considerations

It is not known if pitavastatin is present in breast milk.

HMG-CoA reductase inhibitors (statins) decrease the synthesis of cholesterol and substances derived from cholesterol. Normal concentrations of cholesterol in breast milk are required for infant development (Holmsen 2017; Lecarpentier 2012). Due to the potential for adverse events in the breastfed infant, breastfeeding is not recommended by the manufacturer. Available guidelines recommend resuming statin therapy once breastfeeding is completed (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]).

Dietary Considerations

Red yeast rice contains variable amounts of several compounds that are structurally similar to HMG-CoA reductase inhibitors, primarily monacolin K (or mevinolin) which is structurally identical to lovastatin; concurrent use of red yeast rice with HMG-CoA reductase inhibitors may increase the incidence of adverse and toxic effects (Lapi 2008; Smith 2003).

Monitoring Parameters

ACC/AHA Blood Cholesterol Guideline recommendations ( ACC/AHA [Grundy 2019]):

Lipid panel (total cholesterol, HDL, LDL, triglycerides): Lipid profile (fasting or nonfasting) before initiating treatment. Fasting lipid profile should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter. If 2 consecutive LDL levels are <40 mg/dL, consider decreasing the dose.

Hepatic transaminase levels: Baseline measurement of hepatic transaminase levels (AST and ALT); measure AST, ALT, total bilirubin, and alkaline phosphatase if symptoms suggest hepatotoxicity (eg, unusual fatigue or weakness, loss of appetite, abdominal pain, dark-colored urine or yellowing of skin or sclera) during therapy.

CPK: CPK should not be routinely measured. Baseline CPK measurement is reasonable for some individuals (eg, family history of statin intolerance or muscle disease, clinical presentation, concomitant drug therapy that may increase risk of myopathy). May measure CPK in any patient with symptoms suggestive of myopathy (pain, tenderness, stiffness, cramping, weakness, or generalized fatigue).

Evaluate for new-onset diabetes mellitus during therapy; if diabetes develops, continue statin therapy and encourage adherence to a heart-healthy diet, physical activity, a healthy body weight, and tobacco cessation.

If patient develops a confusional state or memory impairment, may evaluate patient for nonstatin causes (eg, exposure to other drugs), systemic and neuropsychiatric causes, and the possibility of adverse effects associated with statin therapy.

Manufacturer's labeling: Consider neuromuscular and serologic testing if immune-mediated necrotizing myopathy is suspected.

Mechanism of Action

Inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme in cholesterol synthesis (reduces the production of mevalonic acid from HMG-CoA); this then results in a compensatory increase in the expression of LDL receptors on hepatocyte membranes and a stimulation of LDL catabolism. In addition to the ability of HMG-CoA reductase inhibitors to decrease levels of high-sensitivity C-reactive protein (hsCRP), they also possess pleiotropic properties including improved endothelial function, reduced inflammation at the site of the coronary plaque, inhibition of platelet aggregation, and anticoagulant effects (de Denus 2002; Ray 2005).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: ~148 L

Protein binding: >99%, primarily to albumin and alpha 1-acid glycoprotein

Metabolism: Hepatic, via UGT1A3 and UGT2B7; minimal metabolism via CYP2C9 and CYP2C8

Bioavailability: 51%

Half-life elimination: ~12 hours

Time to peak, plasma: ~1 hour

Excretion: Feces (79%); urine (15%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: C_max and AUC were 60% and 102% higher in patients with GFR 30 to 59 mL/minute/1.73 m² and 40% and 86% higher in patients with ESRD on hemodialysis, respectively.

Hepatic function impairment: Half-life was 15 and 10 hours for patients with moderate and mild impairment, respectively.

Older adult: C_max and AUC were 10% and 30% higher, respectively, in elderly patients compared with younger patients.

Sex: C_max and AUC were 60% and 54% higher, respectively, in women compared with men.

Race/ethnicity: C_max and AUC were 21% and 5% lower, respectively, in black patients compared with white patients.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Livazo;
(AR) Argentina: Pivast;
(BD) Bangladesh: Pavigard | Pitavas | Pivalo | Pivasta;
(BE) Belgium: Kadosyn;
(BG) Bulgaria: Lipocante | Pitaavia | Pratin;
(BR) Brazil: Ebatz | Livalo | Pitavas calcica | Pivast;
(CH) Switzerland: Livazo;
(CN) China: Livalo | Pitavastatin calcium tablets;
(CO) Colombia: Redevant;
(DE) Germany: Livazo;
(EG) Egypt: Lipidalon | Lipovastatin | Lividemia | Pivastalo;
(ES) Spain: Alipza | Livazo | Pitavastatina alter | Pitavastatina cinfa | Pitavastatina kern | Pitavastatina krka | Pitavastatina normon | Pitavastatina pensa | Pitavastatina ratiopharm | Pitavastatina sandoz | Pitavastatina stada | Pitavastatina tecnigen | Pitavastatina teva;
(FR) France: Lippiza | Trolise;
(GR) Greece: Livazo | Pitava | Pitavador | Pitavastatin/stada;
(ID) Indonesia: Livalo | Vitor;
(IN) India: Flovas | Pitava | Pivasta;
(IT) Italy: Alipza | Livazo;
(JO) Jordan: Livazo;
(JP) Japan: Livalo | Pitavastatin ca | Pitavastatin ca kyorin | Pitavastatin calcium kog | Pitavastatin calcium mochida | Pitavastatin calcium teva;
(KE) Kenya: Pitava;
(KR) Korea, Republic of: Auspita | Boryung pitavastatin | Daewoong pitavastatin | Dongkwang pitavastatin | Elbaro | Gl pitavastatin calcium | Ibatin | Kbaro | Lipatin | Lipita | Lipitafar | Livalo | Livapita | Livaro | Livataro | Lopita | Lovalow | Megastatin | Myungmoon pitavastatin | Newbaro | Pevaro | Pirava | Pista | Pistatin | Pita | Pita Q | Pita S | Pitadin | Pitaduce | Pitadus | Pitalow | Pitanex | Pitaron | Pitarotin | Pitarova | Pitas | Pitastin | Pitaterol | Pitatin | Pitava | Pitavan | Pitavarotin | Pitavas | Pitavastatin | Pitavatan | Pitrovan | Pivaglo | Pivaro | Pivast | Pivastan | Pivastin | Pivatin | Pqlow | Tamastin | Tastin | Tavalow | Tavaratin | Tavasta | Tavastar | Unipita;
(KW) Kuwait: Livazo;
(LB) Lebanon: Pival;
(MX) Mexico: Livalo | Redevant;
(NO) Norway: Livalo;
(PH) Philippines: Pitator;
(PK) Pakistan: Alipza | Pit stat | Pitacol | Pitalo | Pitamax | Pitastin | Pitava | Pivast;
(PL) Poland: Pitamet;
(PR) Puerto Rico: Zypitamag;
(PT) Portugal: Alipza | Livazo | Pitavastatina alter | Pitavastatina bluepharma | Pitavastatina ciclum | Pitavastatina Generis | Pitavastatina krka | Pitavastatina pharmakern | Pitavastatina ratiopharm | Pitavastatina TAD | Pitavastatina teva | Pitavastatina tolife | Pitavastatina zentiva;
(QA) Qatar: Livazo;
(RU) Russian Federation: Livazo;
(SA) Saudi Arabia: Livazo;
(SG) Singapore: Livalo;
(TH) Thailand: Livalip | Nikp pitavastatin | Pitalip | Pitasor;
(TR) Turkey: Alipza | Pratin;
(TW) Taiwan: Lavitol | Lipozol | Livalo | Pitanxo | Pitarty | Pitastatin | Pitavol | Pivas | Zulitor;
(UA) Ukraine: Livazo;
(UY) Uruguay: Pivast

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Pitavastatin: Drug information