| Fact Table | |
|---|---|
| Formula | C25H24FNO4 (pitavastatin); C50H46CaF2N2O8 (pitavastatin calcium) |
| License | FDA approved (Livalo NDA 022363; initial U.S. approval 2009); Health Canada DPD listing found for pitavastatin products |
| Bioavailability | 51% absolute bioavailability for oral solution; high-fat meal decreases Cmax by 43% but does not significantly reduce AUC |
| Legal status | Prescription only (Rx; Prescription in Canada) |
| Chemical Name | (+)-monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate} |
| Elimination half-life | Approximately 12 hours |
| Dosage (Strength) | 1 mg, 2 mg and 4 mg film-coated oral tablets; recommended dosage range 2–4 mg once daily, maximum 4 mg once daily; renal impairment starting dose 1 mg once daily, maximum 2 mg once daily |
| Pregnancy | May cause fetal harm; discontinue when pregnancy is recognized or consider the ongoing therapeutic needs of the individual patient |
| Brands | Livalo; Zypitamag; Livazo; Alipza; generic pitavastatin calcium tablets |
| Protein binding | More than 99%, mainly to albumin and alpha-1 acid glycoprotein |
| PubChem CID | 5282452 (pitavastatin); 5282451 (pitavastatin calcium) |
| MedlinePlus | a610018 |
| ChEBI | 32020 |
| ATC code | C10AA08 |
| DrugBank | DB08860 |
| KEGG | D01862 (pitavastatin calcium); D10568 (pitavastatin calcium hydrate) |
| Routes of administration | By mouth (oral film-coated tablets) |
Livalo (pitavastatin) is a prescription medication that helps lower LDL cholesterol alongside a balanced diet. Livalo is a type of statin that works by reducing how much cholesterol the liver makes. As a result, it helps the liver remove more LDL cholesterol from the blood. Livalo is used in adults with high cholesterol and in adults and children age 8 and older with heterozygous familial hypercholesterolemia (HeFH), an inherited condition that causes high cholesterol.
Take Livalo by mouth once per day, with or without food, at about the same time each day.
The usual dose is 2 mg to 4 mg once daily, and the highest recommended dose is 4 mg once daily.
If you have moderate or severe kidney problems or are on hemodialysis, your dose may start at 1 mg once daily, with a maximum dose of 2 mg once daily.
Your healthcare provider may check your cholesterol with a blood test about 4 weeks after you start Livalo or after a dose change.
Swallow the tablet whole.
Take Livalo exactly as prescribed, and do not stop taking it without talking to your healthcare provider.
Healthy lifestyle habits, such as eating a heart-healthy diet, exercising, and managing weight, are also important.
The active ingredient in Livalo is pitavastatin. The inactive ingredients may include hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium aluminometasilicate, and magnesium stearate.
Before using this medication, you may want to consult a healthcare provider about the following:
Avoid taking or using this medication if any of the following apply:
Livalo may cause muscle problems, including myopathy and a more severe form called rhabdomyolysis, in which muscle tissue breaks down and damages the kidneys. The risk is higher in people aged 65 and older, those with untreated low thyroid (hypothyroidism), people with kidney problems, those taking certain other medicines, and at higher Livalo doses.
A rare autoimmune muscle problem called immune-mediated necrotizing myopathy (IMNM) has been reported with statins. It causes persistent muscle weakness and elevated creatine kinase that don’t improve when the statin is stopped.
Livalo can affect the liver. Mild increases in liver enzymes can happen, and rare cases of fatal or serious liver failure have been reported. Liver enzyme tests are often checked before starting Livalo and as needed after that.
Livalo has important drug interactions beyond cyclosporine. Erythromycin, rifampin, niacin, and fibrate medications such as gemfibrozil can change pitavastatin levels or increase the risk of muscle injury.
People with kidney problems often need a lower starting and maximum dose of Livalo. Tell your provider about any kidney disease, especially if you’re on dialysis.
Use during pregnancy may cause harm to an unborn baby and is generally avoided. Breastfeeding is not recommended while taking Livalo.
Heavy alcohol use can increase the risk of liver problems on a statin. Tell your provider about how much alcohol you drink so they can give appropriate guidance.
Statins, including Livalo, may increase blood sugar levels and the risk of being diagnosed with type 2 diabetes.
Common side effects of Livalo include:
Get medical help for any signs of a serious allergic reaction such as swelling of the face, lips, tongue, or throat, trouble breathing, or a severe rash.
Stop Livalo and contact your healthcare provider if you notice unexplained muscle pain, tenderness, weakness (especially if you also have fever or unusual tiredness), dark or cola-colored urine, or a decrease in urine output.
Other serious problems include liver injury with yellowing of the skin or eyes, nausea, or upper-right abdominal pain.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.