Pitavastatin is an HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. It is available as tablets for oral use. MedsAcross supplies Pitavastatin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). LIVALO is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.
Source: US FDA prescribing information
Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic pathway for cholesterol. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very low density lipoproteins.
Source: US FDA prescribing information
Take 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 LIVALO 4 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of LIVALO, and adjust the dosage if necessary. Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. 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. See full prescribing information for LIVALO dosage modifications due to drug interactions.
Source: US FDA prescribing information
LIVALO is contraindicated in the following conditions: Concomitant use of cyclosporine. Acute liver failure or decompensated cirrhosis. Hypersensitivity to pitavastatin or any excipents in LIVALO. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with LIVALO. Cyclosporine. Active liver failure or decompensated cirrhosis. Hypersensitivity to pitavastatin or any excipients in LIVALO
Source: US FDA prescribing information
Myopathy and Rhabdomyolysis: Risk factors include age 65 or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher LIVALO dosage. Discontinue LIVALO if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue LIVALO 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 LIVALO dosage. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue LIVALO if IMNM is suspected.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in other sections of the labeling: Myopathy and Rhabdomyolysis Immune-Mediated Necrotizing Myopathy Hepatic Dysfunction Increases in HbA1c and Fasting Serum Glucose Levels The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation,, diarrhea, back pain, and pain in extremity.
Source: US FDA prescribing information
Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with LIVALO and instructions for preventing or managing drug interactions. Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with LIVALO Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with LIVALO is contraindicated. Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including LIVALO. Intervention: Avoid concomitant use of gemfibrozil with LIVALO.
Source: US FDA prescribing information
Store at room temperature between 15°C and 30°C (59° to 86° F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
11 presentations of Pitavastatin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Pitavastatin 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pitavastatin 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pitavastatin 4 mg tabletOralGeneric name | — | US FDA | Available on request |
| Zypitamag 2 mg tabletOral | Medicure International | US FDA | Available on request |
| Zypitamag 4 mg tabletOral | Medicure International | US FDA | Available on request |
| Pitavastatin 2.09 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pitavastatin 4.18 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pitavastatin 1.045 mg tabletOralGeneric name | — | US FDA | Available on request |
| Livalo 1.045 mg tabletOral | Kowa Pharmaceuticals | US FDA | Available on request |
| Livalo 2.09 mg tabletOral | Kowa Pharmaceuticals | US FDA | Available on request |
| Livalo 4.18 mg tabletOral | Kowa Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 3 August 2009 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Pitavastatin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 11 presentations of Pitavastatin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Pitavastatin, including Livalo, Zypitamag.
Yes. The US FDA first approved Pitavastatin on 3 August 2009, according to Drugs@FDA.
No listed presentation of Pitavastatin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Pitavastatin is classified under ATC code C10AA08 (Pitavastatin).
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