livalo
Livalo (Pitavastatin Calcium) is a HMG-CoA reductase inhibitor used to treat Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.
Pitavastatin Calcium · by Kowa Co
Available as a generic: Pitavastatin Calcium
Key facts
- Active ingredient
- Pitavastatin Calcium
- Drug class
- Hmg-Coa Reductase Inhibitor
- Form
- Tablet
- Strength
- Pitavastatin Calcium EQ 1MG Base · Pitavastatin Calcium EQ 2MG Base · Pitavastatin Calcium EQ 4MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Kowa Co
- Half-life
- about 12 hours (how long it stays in your system)
- What the pharmacy pays
- ~$38.04 for 30 — not your price
- FDA application
- NDA022363
What is Livalo?
From the FDA label:LIVALO (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis {(3R, 5S, 6 E )-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. The structural formula is: The empirical formula for pitavastatin is C 50 H 46 CaF 2 N 2 O 8 and the molecular weight is 880.98. Pitavastatin is odorless and occurs as white to pale-yellow powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of LIVALO contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropylcellulose, magnesium aluminometasilicate, and magnesium stearate. The film coating contains the following inactive ingredients: colloidal anhydrous silica, hypromellose, titanium dioxide, and triethyl citrate. Chemical Structure
How to use
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 LIVALO 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 LIVALO, 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 LIVALO dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information Take LIVALO orally once daily with or without food at the same time each day. For patients that require 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 initiating LIVALO, and adjust the dosage if necessary. 2.2 Recommended Dosage for Adults and Pediatric Patients Aged 8 Years and Older The recommended dosage range of LIVALO is 2 mg to 4 mg daily. The maximum recommended dosage is LIVALO 4 mg…
Side effects
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, , diarrhea, back pain, and pain in extremity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Kowa Pharmaceuticals America, Inc. at 1-877-334-3464 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 LIVALO 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…
Warnings
Important safety 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. ( 5.1 , 7 , 8.5 , 8.6 ) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue LIVALO 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 enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO. ( 5.3 ) 5.1 Myopathy and Rhabdomyolysis LIVALO may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including LIVALO. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use of certain drugs (including other lipid-lowering therapies), and higher LIVALO dosage [see Dosage and Administration (2.2) , Drug Interactions (7) , and Use in Specific Populations (8.5 , 8.6) ] . Dosages of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. The maximum recommended dose of LIVALO is 4 mg once daily . Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis LIVALO is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil [see Contraindications (4) and Drug Interactions (7) ]. There are LIVALO dosage restrictions for patients taking erythromycin or rifampin [see Dosage and Administration (2.4) ]. The following drugs when used concomitantly with LIVALO may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1grams/day), fibrates, and colchicine [see Drug Interactions (7) ]. Discontinue LIVALO if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if LIVALO is discontinued. Temporarily discontinue LIVALO in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the LIVALO dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 5.2 Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use , including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue LIVALO if IMNM is suspected. 5.3 Hepatic Dysfunction Increases in serum transaminases have been reported with LIVALO [see Adverse Reactions (6) ]. In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including LIVALO. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. Consider liver enzyme testing before the initiation of LIVALO and when clinically indicated thereafter . LIVALO is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4) ]. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO. 5.4 Increases in HbA1c and Fasting Serum Glucose Levels Increases in HbA1c and fasting serum glucose levels have been reported with statins, including LIVALO. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
Who should not take Livalo
LIVALO is contraindicated in the following conditions: Concomitant use of cyclosporine [see Drug Interactions (7) ]. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ]. Hypersensitivity to pitavastatin or any excipents in LIVALO. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with LIVALO [see Adverse Reactions (6) ] . Cyclosporine ( 4 , 7 ) Active liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to pitavastatin or any excipients in LIVALO ( 4 )
Overdose — what happens if you take too much
No specific treatment for LIVALO 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 LIVALO.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
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 [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ]. 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 [see Contraindications (4) ]. 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. Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis . Intervention: In patients taking erythromycin, do not exceed LIVALO 1 mg once daily [see Dosage and Administration (2.4) ]. Rifampin Clinical Impact: Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis . Intervention: In patients taking rifampin, do not exceed LIVALO 2 mg once daily [see Dosage and Administration (2.4) ]. Fibrates Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including LIVALO. Intervention: Consider if the benefit of using fibrates concomitantly with LIVALO outweighs the increased risk of myopathy and rhabdomyolysis. Niacin Clinical Impact: The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with LIVALO. Intervention: Consider if the benefit of using lipid-modifying doses (≥1 g/day) of niacin concomitantly with LIVALO outweighs the increased risk of myopathy and rhabdomyolysis. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including LIVALO. Intervention: Consider the risk/benefit of concomitant use of colchicine with LIVALO. See full prescribing information for details regarding concomitant use of LIVALO with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 2.4 , 7 )
How long does Pitavastatin Calcium stay in your body?
The elimination half-life of pitavastatin calcium is about 12 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the mean plasma elimination (terminal) half-life the label reports in §12.3 for typical adults; the label gives no separate distribution-phase figure. Pitavastatin is not a prodrug. Its main metabolite is pitavastatin lactone (formed by UGT glucuronidation, with only minimal CYP450 involvement); the label does not describe the lactone as an active moiety and gives no half-life for it, so there is no known active metabolite that outlasts the parent. Liver impairment lengthens it: in the hepatic-impairment study, mean half-life was 15 hours with moderate impairment and 10 hours with mild impairment, versus 8 hours in the healthy volunteers of that same study (a lower figure than the ~12-hour overall mean, so treat these as within-study comparisons rather than absolute values). For kidney impairment the label reports higher exposure (AUC roughly 102% higher in moderate impairment, 86% higher in hemodialysis patients, 36% higher in severe impairment) but does not state a changed half-life. In adults 65 and older, Cmax and AUC were about 10% and 30% higher; again no half-life change is stated. This is not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — PITAVASTATIN CALCIUM (pitavastatin) tablet, film coated — FDA label, §12.3 Pharmacokinetics.
Drug class
How this class works, per HMG-CoA Reductase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Livalo ranks — best-rated HMG-CoA reductase inhibitor for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Livalo treat?
- Livalo (Pitavastatin Calcium) may be used to treat hypercholesterolemia, hyperlipoproteinemias, hypertriglyceridemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Livalo work?
- Livalo is a HMG-CoA reductase inhibitor. Statins block HMG-CoA reductase, the key enzyme the liver uses to make cholesterol. With less cholesterol being produced, the liver pulls more LDL ("bad") cholesterol out of the blood, lowering overall blood cholesterol levels.
- How much does Livalo cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $38.04 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Atorvaliq — about $0.92 on the same basis.
- Is there a coupon or discount for Livalo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Livalo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Livalo?
- Livalo is marketed by Kowa Co. You can see Kowa Co's full profile, rating, and other products on pharmaranks.
- Is Livalo a brand-name or generic drug?
- Livalo is a brand-name product with the active ingredient Pitavastatin Calcium. Lower-cost generic equivalents containing Pitavastatin Calcium are available — ask your pharmacist.
- Is Livalo available over the counter?
- No. Livalo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Livalo come in?
- Livalo is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Livalo?
- Livalo is classified as hmg-coa reductase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Livalo FDA-registered?
- Livalo is on record with the U.S. FDA under application number NDA022363. You can verify this on its official FDA label.
- Is Livalo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Livalo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Livalo?
- Livalo's side effects are taken directly from its FDA label. From the label: 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 H… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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