Pitavastatin

Mechanism-of-action class: Hydroxymethylglutaryl-CoA Reductase Inhibitors.

• Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adult with primary hyperlipidemia. Adults with heterozygous familial hypercholesterolemia (HeFH).ICD-10: E78.00, E78.5

• Pitavastatin tablets are contraindicated in the following conditions: Concomitant use of cyclosporine [see Drug Interactions ( 7 )] . Acute liver failure or decompensated cirrhosis [see Warning and Precautions ( 5.3 )].contraindicated

Take orally once daily with or without food at the same time each day ( 2.1 ). For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatment. ( 2.1 ). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of pitavastatin tablets, and adjust the dosage if necessary. ( 2.1 ). Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. ( 2.2 ) Recommended starting dosage for patients with moderate and severe renal impairment and end-stage renal disease on hemodialysis is 1 mg once daily. Maximum recommended dosage is 2 mg once daily. ( 2.3 ) See full prescribing information for pitavastatin tablets dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information Take pitavastatin tablets orally once daily with or without food at the same time each day. For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of pitavastatin tablets, and adjust the dosage if necessary. 2.2 Recommended Dosage for Adults The recommended dosage range of pitavastatin tablets is 2 mg to 4 mg daily. The maximum recommended dosage is pitavastatin tablets 4 mg once daily.

Myopathy and Rhabdomyolysis: Risk factors include age 65 or greater, renal impairment, uncontrolled hypothyroidism, concomitant use with certain other drugs, and higher doses of pitavastatin tablets. Discontinue pitavastatin tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue pitavastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the pitavastatin tablets dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever ( 5.1 , 7 , 8.5 , 8.6 ). Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue pitavastatin tablets if IMNM is suspected ( 5.2 ). Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzyme before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue pitavastatin tablets ( 5.3 ) 5.1 Myopathy and Rhabdomyolysis Pitavastatin tablets may cause myopathy (muscle pain, tenderness, or weakness with elevated creatine kinase [CK]) and rhabdomyolysis.

The following serious adverse reactions are discussed in other sections of the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warning and Precautions ( 5.2 )] Hepatic Dysfunction [see Warning and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warning and Precautions ( 5.4 )]. The most frequent adverse reactions (rate ≥2%) were myalgia, constipation, back pain, diarrhea, and pain in extremity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of one drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Primary Hyperlipidemia In 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 adult patients with primary hyperlipidemia were administered pitavastatin tablets 1 mg to 4 mg daily. The mean continuous exposure of pitavastatin (1 mg to 4 mg) was 36.7 weeks (median 51.1 weeks). The mean age of the patients was 60.9 years (range; 18 years – 89 years) and 52% were females. Approximately 93% of the patients were White, 7% were Asian/Indian, 0.2% were African American and 0.3% were Hispanic and other.

Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended during treatment with pitavastatin tablets See 17 for PATIENT COUNSELING INFORMATION. Pediatric use information is approved for Kowa Co Ltd’s LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd’s marketing exclusivity rights, this drug product is not labeled with that information. 8.1 Pregnancy Risk Summary Discontinue pitavastatin tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pitavastatin tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pitavastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

No specific treatment for pitavastatin tablets overdose is known. Contact Poison Control (1-800-222-1222) for latest recommendations. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of pitavastatin tablets.

• Aug 3, 2009NDANDA022363Kowa Co
• Dec 20, 2016ANDAANDA206015Aurobindo Pharma
• Feb 3, 2017ANDAANDA205932Orient Pharma Co Ltd
• Feb 3, 2017ANDAANDA205955Sawai Usa
• Jul 14, 2017NDANDA208379Medicure
• Apr 4, 2019ANDAANDA206070Mylan
• Feb 22, 2023ANDAANDA206047Zydus Pharms
• Apr 30, 2024ANDAANDA205977Hetero Labs Ltd V

1. 1Myalgia8268.2%
2. 2Diarrhoea6306.3%
3. 3Fatigue5675.6%
4. 4Nausea5545.5%
5. 5Headache5385.4%
6. 6Arthralgia5145.1%
7. 7Dizziness5035.0%
8. 8Dyspnoea4664.6%
9. 9Malaise4484.5%
10. 10Decreased Appetite4344.3%
11. 11Fall4344.3%
12. 12Pruritus4334.3%
13. 13Asthenia4274.2%
14. 14Pyrexia4264.2%
15. 15Insomnia3813.8%

The 10 most recently updated of 119 ClinicalTrials.gov registrations naming Pitavastatin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Livalozet Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
  Not yet recruiting · Interventional · 5,000 enrolled · Samsung Medical Center
  NCT07626840updated 2026-06-10
• A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants
  Recruiting · Phase 1 · Interventional · 40 enrolled · Hoffmann-La Roche
  NCT06982131updated 2026-06-04
• Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
  Not yet recruiting · Interventional · 1,952 enrolled · Yonsei University
  NCT07524101updated 2026-05-19
• A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
  Recruiting · Phase 1 · Interventional · 12 enrolled · AbbVie
  NCT07567781updated 2026-05-05
• PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)
  Recruiting · Phase 1 · Interventional · 18 enrolled · University of California, Irvine
  NCT07549958updated 2026-05-04
• A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
  Completed · Phase 1 · Interventional · 12 enrolled · Basilea Pharmaceutica
  NCT06808646updated 2026-04-21
• Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study
  Recruiting · Observational · 10,000 enrolled · JW Pharmaceutical
  NCT07523971updated 2026-04-13
• TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men
  Recruiting · Phase 2 · Interventional · 150 enrolled · Lomonosov Moscow State University Medical Research and Educational Center
  NCT07460960updated 2026-03-16
• Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
  Completed · Observational · 6,927 enrolled · JW Pharmaceutical
  NCT07445542updated 2026-03-03
• Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides
  Active not recruiting · Phase 4 · Interventional · 88 enrolled · JW Pharmaceutical
  NCT07442630updated 2026-03-02

CPIC-curated drug–gene pairs for Pitavastatin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP3A4CPIC C
  SLCO1B1, ABCG2, CYP2C9, and Statins
• CYP3A5CPIC C
  SLCO1B1, ABCG2, CYP2C9, and Statins
• HMGCRCPIC C
  SLCO1B1, ABCG2, CYP2C9, and Statins
• SLCO1B1CPIC AClinPGx 1A
  SLCO1B1, ABCG2, CYP2C9, and Statins

Frequently asked questions

How does Pitavastatin work?

Mechanism-of-action class: Hydroxymethylglutaryl-CoA Reductase Inhibitors.

What is Pitavastatin used for?

According to FDA labeling, Pitavastatin carries indications including: Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adult with primary hyperlipidemia. Adults with heterozygous familial hypercholesterolemia (HeFH).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pitavastatin?

Pitavastatin is classified as HMG CoA reductase inhibitors, HMG-CoA Reductase Inhibitor, Hydroxymethylglutaryl-CoA Reductase Inhibitors.

What are the brand names for Pitavastatin?

Pitavastatin is marketed under brand names including Livalo, Nikita, Zypitamag.

What are the contraindications for Pitavastatin?

Pitavastatin labeling lists contraindications including: Pitavastatin tablets are contraindicated in the following conditions: Concomitant use of cyclosporine [see Drug Interactions ( 7 )] . Acute liver failure or decompensated cirrhosis [see Warning and Precautions ( 5.3 )].. Always consult the full prescribing information and a clinician.