Side effects of livalo

Contents

Livalo

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) .
  • Liver Enzyme Abnormalities .

Of 4,798 patients enrolled in 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 patients were administered pitavastatin 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 the gender distribution was 48% males and 52% females. Approximately 93% of the patients were Caucasian, 7% were Asian/Indian, 0.2% were African American and 0.3% were Hispanic and other.

Clinical Studies Experience

Because clinical studies on LIVALO are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of LIVALO cannot be directly compared with that in the clinical studies of other HMG-CoA reductase inhibitors and may not reflect the frequency of adverse reactions observed in clinical practice.

Adverse reactions reported in ≥ 2% of patients in controlled clinical studies and at a rate greater than or equal to placebo are shown in Table 1. These studies had treatment duration of up to 12 weeks.

Table 1. Adverse Reactions* Reported by ≥2.0% of Patients Treated with LIVALO and >Placebo in Short-Term Controlled Studies

Other adverse reactions reported from clinical studies were arthralgia, headache, influenza, and nasopharyngitis.

The following laboratory abnormalities have also been reported: elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin, and glucose.

Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with LIVALO.

In a double-blind, randomized, controlled, 52-week trial, 252 HIV-infected patients with dyslipidemia were treated with either LIVALO 4mg once daily (n=126) or another statin (n=126). All patients were taking antiretroviral therapy (excluding darunavir) and had HIV-1 RNA less than 200 copies/mL and CD4 count greater than 200 cell/μL for at least 3 months prior to randomization. The safety profile of LIVALO was generally consistent with that observed in the clinical trials described above. One patient (0.8%) treated with LIVALO had a peak creatine phosphokinase value exceeding 10 times the upper limit of normal (10x ULN), which resolved spontaneously. Four patients (3%) treated with LIVALO had at least one ALT value exceeding 3x but less than 5x ULN, none of which led to drug discontinuation. Virologic failure was reported for four patients (3%) treated with LIVALO, defined as a confirmed measurement of HIV-1 RNA exceeding 200 copies/mL that was also more than a 2-fold increase from baseline.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LIVALO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions associated with LIVALO therapy reported since market introduction, regardless of causality assessment, include the following: abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and non-fatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction, muscle spasms and peripheral neuropathy.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use .

Read the entire FDA prescribing information for Livalo (Pitavastatin)

Livalo Side Effects

Generic Name: pitavastatin

Medically reviewed by Drugs.com. Last updated on Jan 28, 2019.

  • Overview
  • Side Effects
  • Dosage
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Note: This document contains side effect information about pitavastatin. Some of the dosage forms listed on this page may not apply to the brand name Livalo.

For the Consumer

Applies to pitavastatin: oral tablet

Along with its needed effects, pitavastatin (the active ingredient contained in Livalo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pitavastatin:

Less common

  • Difficulty with moving
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • pain in the arms and legs
  • swollen joints

Incidence not known

  • Chills
  • clay-colored stools
  • cough
  • dark urine
  • diarrhea
  • difficulty breathing
  • dizziness
  • fever
  • general feeling of discomfort or illness
  • headache
  • loss of appetite
  • muscle spasm
  • nausea
  • runny nose
  • shivering
  • sore throat
  • stomach pain
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Some side effects of pitavastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Back pain
  • difficulty having a bowel movement

Incidence not known

  • Burning, numbness, tingling, or painful sensations
  • decreased interest in sexual intercourse
  • discouragement
  • feeling sad or empty
  • hives or welts, itching skin, or rash
  • inability to have or keep an erection
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • loss of interest or pleasure
  • loss of memory
  • problems with memory
  • redness of the skin
  • trouble concentrating
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to pitavastatin: oral tablet

General

The most frequently reported side effects have included myalgia, back pain, diarrhea, constipation, and extremity pain.

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea

Postmarketing reports: Abdominal discomfort, abdominal pain, dyspepsia, nausea

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, pain in extremity

Frequency not reported: Arthralgia, rhabdomyolysis, myopathy, myositis, elevated creatinine phosphokinase

Postmarketing reports: Muscle spasm

Hepatic

Frequency not reported: Bilirubin increased, liver enzymes abnormal, elevated transaminases, elevated alkaline phosphatase

Postmarketing reports: Hepatitis, jaundice, fatal hepatic failure, nonfatal hepatic failure

Dermatologic

Frequency not reported: Rash, pruritus, urticaria

Other

Frequency not reported: Influenza, creatine phosphokinase increased, transaminases increased, alkaline phosphatase increased

Postmarketing reports: Asthenia, fatigue, malaise

Nervous system

Frequency not reported: Headache

Postmarketing reports: Dizziness, hypoesthesia, peripheral neuropathy

Metabolic

Frequency not reported: HbA1c elevations, fasting serum glucose elevations, increased blood glucose

Renal

Frequency not reported: Acute renal failure, myoglobinuria

Respiratory

Frequency not reported: Nasopharyngitis

Postmarketing reports: Interstitial lung disease

Hypersensitivity

Frequency not reported: Hypersensitivity reactions including rash, pruritus, and urticaria

Psychiatric

There have been reports of cognitive impairment such as memory loss, forgetfulness, amnesia, memory impairment, and confusion associated with statin use. These reports are generally nonserious, and reversible with drug discontinuation. Time to symptom onset has been reported as 1 day to years with resolution at a median of 3 weeks following discontinuation.

Postmarketing reports: Insomnia, depression

Statin use:

Postmarketing report: Confusion, cognitive impairment, memory loss, forgetfulness, amnesia, memory impairment

Genitourinary

Postmarketing reports: Erectile dysfunction

Immunologic

Statin use:

Postmarketing reports: Immune-mediated necrotizing myopathy

1. “Product Information. Livalo (pitavastatin).” Kowa Pharmaceuticals America (formerly ProEthic), Montgomery, AL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

  • What are the side effects of statins?

Medical Disclaimer

More about Livalo (pitavastatin)

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Consumer resources

  • Livalo
  • Livalo (Advanced Reading)

Other brands: Zypitamag, Nikita

Professional resources

  • Livalo (AHFS Monograph)
  • … +1 more

Related treatment guides

  • Dyslipidemia
  • High Cholesterol

PMC

Case Report

A 37-year-old female, a known case of bronchial asthma since childhood and who was on inhalers, was diagnosed about 2 months ago as hyperlipidemia and started on pitavastatin calcium 4 mg once daily, by her cardiologist 7 weeks ago.

She presented to the emergency room complaining of chest pain, a characteristic chest wall pain which was crushing in nature but with no cardiac origin. It had begun gradually 10 days before, was retro-sternal, was non-radiating, was severe 10/10 (visual analog pain scale), was aggravated by minimal exertion, and was relieved by rest. It was associated with shortness of breathing on exertion. There were no palpitations, syncopal attacks, nor fever. There was no past medical history of a similar condition and no previous hospitalization. Her bronchial asthma was well controlled on inhalers. She had no family history of similar condition and not known to have any other comorbidities. She is not a smoker and does not drink alcohol. She is a medical staff by profession and unmarried. On examination, she looked anxious, not distressed, fully conscious, and oriented.

The patient noticed that she had put on about 10 kg of weight in the previous 6 weeks. Before taking pitavastatin, she weighed 85 kg, and her height was 163 cm. Her weight had risen to 95 kg after she began pitavastatin. Her body mass index (BMI) was 35.8.

Her blood pressure was 130/80 and heart rate was 86/min, regular. Cardiovascular examination was uneventful. Respiratory system was normal apart from a drop in oxygen saturation from 99% to 94% on walking a short distance. Abdomen was soft, not tender, and no mass was detected. There was no dependent edema.

Computed tomography (CT) pulmonary angiogram showed no pulmonary embolism. CT coronary angiography showed normal coronary arteries, no coronary arteries atherosclerosis, and no stenosis.

The patient was admitted to the cardiac ward and started on telemetry observation. Arterial blood gas analysis was normal, and a 6-min walk test revealed a drop in oxygen saturation from 98% to 91% in room air, associated with severe crushing chest pain which affected her breathing. Pulmonary function test and sleep study were normal.

Although rapid weight gain was to blame for all of these symptoms, all the investigations were negative. The patient was reassured that it was neither an acute coronary syndrome nor coronary artery disease and was discharged after 4 days of admission with full investigation and assessment of her chest pain.

The patient stopped pitavastatin on her own as a trial as she had read about its side effects especially with regard to chest pain. After 3 days, her chest pain and all symptoms such as insomnia subsided and completely disappeared. Accordingly, a final diagnosis of pitavastatin-induced chest pain was made, as a rare side effect of the medication.

Generic Name: pitavastatin (pit AV a STAT in)
Brand Names: Livalo, Zypitamag

Medically reviewed by Sanjai Sinha, MD Last updated on Nov 1, 2019.

  • Overview
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What is Livalo?

Livalo (pitavastatin) belongs to a group of drugs called HMG CoA reductase inhibitors, or “statins.”

Livalo is used together with diet to lower blood levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides, to increase levels of “good” cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Livalo is used to treat high cholesterol in adults. Lowering your cholesterol may help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

Important information

You should not take Livalo if you have liver disease (including significantly abnormal liver enzyme tests), or if you also take cyclosporine.

Do not take Livalo if you are pregnant.

Do not breast-feed while you are taking Livalo.

Before taking this medicine

You should not use Livalo if you are allergic to pitavastatin, or if you have:

  • liver disease (including significantly abnormal liver enzyme tests);

  • if you are pregnant or breast-feeding; or

  • if you are taking cyclosporine.

This medicine can harm an unborn baby or cause birth defects. Do not use Livalo if you are pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking Livalo.

Pitavastatin can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are taking Livalo.

To make sure Livalo is safe for you, tell your doctor if you have ever had:

  • kidney disease;

  • liver disease;

  • a thyroid disorder; or

  • if you drink more than 2 alcoholic beverages daily.

Livalo can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Livalo?

Take Livalo exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Livalo with or without food.

While using Livalo, you may need frequent blood tests to check your liver function.

You may need to stop using Livalo for a short time if you have:

  • uncontrolled seizures;

  • an electrolyte imbalance (such as high or low potassium levels in your blood);

  • severely low blood pressure;

  • a severe infection or illness;

  • dehydration; or

  • surgery or a medical emergency.

Livalo is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light.

Livalo dosing information

Usual Adult Dose for Hyperlipidemia:

Initial dose: 2 mg orally once a day with or without food
Maintenance dose: 1 to 4 mg once a day with or without food
Maximum dose: 4 mg once a day with or without food

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Livalo?

Avoid eating foods that are high in fat or cholesterol. Livalo will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Drinking alcohol can can raise triglyceride levels and may increase your risk of liver damage.

Livalo side effects

Get emergency medical help if you have any signs of an allergic reaction to Livalo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Livalo can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

  • confusion, memory problems;

  • kidney problems – vomiting, pain in your side or lower back, little or no urinating, swelling, rapid weight gain; or

  • liver problems – loss of appetite, stomach pain (upper right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Livalo side effects may include:

  • mild muscle pain;

  • pain in your arms or legs;

  • back pain; or

  • diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Livalo?

Tell your doctor about all other medicines you use. Like pitavastatin, certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

This list is not complete. Other drugs may interact with pitavastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Livalo only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 5.03.

  • What are the side effects of statins?

Medical Disclaimer

Livalo is the brand name of the prescription drug pitavastatin, used to treat high cholesterol.

It belongs to a class of drugs called HMG-CoA reductase inhibitors, commonly known as statins.

Lowering LDL cholesterol may help prevent vascular conditions such as heart disease, vascular disease, heart attack, and stroke.

The U.S. Food and Drug Administration (FDA) approved Livalo in 2009. It’s manufactured by Kowa Pharmaceuticals America, Inc.

Livalo Warnings

Don’t take Livalo if you have liver disease.

Your doctor will probably order tests to check how well your liver is functioning before prescribing this medicine.

Let your doctor know if you’ve ever had liver disease or consumed large amounts of alcohol.

Livalo may not be suitable for adults age 65 or older may also make you less suitable for Livalo.

Also, tell your doctor if you have, or have ever had, any of the following conditions before taking Livalo:

  • Seizures
  • Muscle aches or weakness
  • Low blood pressure
  • Thyroid disease
  • Kidney disease

Livalo can cause a serious condition that leads to kidney failure. This problem is more likely to occur in older adults, people with kidney disease, and those with an underactive thyroid.

Your doctor will probably tell you not to take Livalo if you also take the medicines Gengraf, Neoral, or Sandimmune (cyclosporine).

Don’t give Livalo to a child under 18 without first talking with a doctor.

Continue to take this medicine even if you feel well. Don’t stop using Livalo without talking with your doctor.

Carefully follow the diet plan that your healthcare provider recommends. Livalo won’t be as effective at lowering your cholesterol if you don’t follow these recommendations.

Let your doctor know you’re taking Livalo before having any type of surgical procedure, including a dental procedure.

Your doctor will probably want to perform frequent tests to monitor your body’s response to Livalo. Keep all appointments with your doctor’s office and laboratory.

Pregnancy and Livalo

Livalo can harm an unborn baby and cause birth defects. Don’t take this medicine if you’re pregnant.

Be sure to use an effective form of birth control while taking Livalo.

The drug can also pass into breastmilk and may harm a breastfeeding baby. Don’t breastfeed while taking Livalo.

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Side Effects of Statins

There are currently seven types of statins approved by the U.S. Food and Drug Administration (FDA).

They include:

Common side effects of all statins

Side effects reported by some people include muscle pain and digestive problems.

Muscle pain is the most common side effect caused by statin use. A 2014 assessment found that intolerance of statins is a real issue usually noted as muscle-related symptoms. It’s estimated that between 1 and 10 percent of muscle symptoms are related to statin use.

Muscle pain can be uncomfortable. However, you should call your doctor right away if you have:

  • unusual muscle pain or cramps
  • tiredness
  • fever
  • dark urine
  • diarrhea

These could be symptoms of rhabdomyolysis. This is a dangerous muscle breakdown condition that can cause kidney problems.

For more information on what puts you at risk of these effects, as well as how they’re treated, read about why statins cause muscle pain.

Rare side effects of all statins

While taking statins, there’s a small risk of:

  • memory loss or confusion
  • increased blood sugar, which can lead to diabetes
  • kidney or liver damage

Dark or bloody urine or pain in your upper abdomen or chest can be signs of serious kidney and liver disorders. If you have any of these symptoms while taking a statin, call your doctor right away.

Lovastatin

Lovastatin generally causes fewer side effects than other, stronger statins. The most common side effects of this drug include:

  • digestive discomfort
  • infection symptoms
  • muscle pain or weakness

Taking lovastatin with a meal can sometimes ease digestive trouble.

Simvastatin

When taken at high doses, simvastatin may be more likely to cause muscle pain than other statins. The more common side effects of taking higher doses of this drug also include:

  • dizziness
  • fast or irregular heartbeat

Pravastatin

People taking pravastatin have reported fewer muscle aches and other side effects.

It’s generally well-tolerated with long-time use. However, the following side effects can occur with this drug:

  • muscle stiffness
  • painful joints

Atorvastatin

The most common side effects of atorvastatin use include:

  • headache
  • stuffy or runny nose

Fluvastatin

Fluvastatin is an alternative for people who have had muscle pain when taking other, stronger statins. However, side effects of this drug are still possible.

The most common side effects from using fluvastatin are:

  • diarrhea
  • joint pain
  • unusual tiredness or trouble sleeping
  • vomiting

Infection symptoms are other common side effects of using fluvastatin. Infection can cause:

  • chills
  • fever
  • runny nose
  • sore throat
  • sweating

Rosuvastatin

Rosuvastatin has the highest rates of reported side effects. Taking a lower dose may reduce or eliminate uncomfortable side effects.

The most common side effects with rosuvastatin are:

  • headache
  • joint pain
  • muscle pain and stiffness
  • rash

CLINICAL PHARMACOLOGY

Mechanism Of Action

Pitavastatin competitively inhibits HMG-CoA reductase, which is a rate-determining enzyme involved with biosynthesis of cholesterol, in a manner of competition with the substrate so that it inhibits cholesterol synthesis in the liver. 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. Further, the sustained inhibition of cholesterol synthesis in the liver decreases levels of very low density lipoproteins.

Pharmacodynamics

In a randomized, double-blind, placebo-controlled, 4-way parallel, active-comparator study with moxifloxacin in 174 healthy participants, LIVALO was not associated with clinically meaningful prolongation of the QTc interval or heart rate at daily doses up to 16 mg (4 times the recommended maximum daily dose).

Pharmacokinetics

Absorption

Pitavastatin peak plasma concentrations are achieved about 1 hour after oral administration. Both Cmax and AUC0-inf increased in an approximately dose-proportional manner for single LIVALO doses from 1 to 24 mg once daily. The absolute bioavailability of pitavastatin oral solution is 51%. Administration of LIVALO with a high fat meal (50% fat content) decreases pitavastatin Cmax by 43% but does not significantly reduce pitavastatin AUC. The Cmax and AUC of pitavastatin did not differ following evening or morning drug administration. In healthy volunteers receiving 4 mg pitavastatin, the percent change from baseline for LDL-C following evening dosing was slightly greater than that following morning dosing. Pitavastatin was absorbed in the small intestine but very little in the colon.

Distribution

Pitavastatin is more than 99% protein bound in human plasma, mainly to albumin and alpha 1-acid glycoprotein, and the mean volume of distribution is approximately 148 L. Association of pitavastatin and/or its metabolites with the blood cells is minimal.

Metabolism

Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8. The major metabolite in human plasma is the lactone which is formed via an ester-type pitavastatin glucuronide conjugate by uridine 5′-diphosphate (UDP) glucuronosyltransferase (UGT1A3 and UGT2B7).

Excretion

A mean of 15% of radioactivity of orally administered, single 32 mg 14C-labeled pitavastatin dose was excreted in urine, whereas a mean of 79% of the dose was excreted in feces within 7 days. The mean plasma elimination half-life is approximately 12 hours.

Race

In pharmacokinetic studies pitavastatin Cmax and AUC were 21 and 5% lower, respectively in Black or African American healthy volunteers compared with those of Caucasian healthy volunteers. In pharmacokinetic comparison between Caucasian volunteers and Japanese volunteers, there were no significant differences in Cmax and AUC.

Gender

In a pharmacokinetic study which compared healthy male and female volunteers, pitavastatin Cmax and AUC were 60 and 54% higher, respectively in females. This had no effect on the efficacy or safety of LIVALO in women in clinical studies.

Geriatric

In a pharmacokinetic study which compared healthy young and elderly (≥65 years) volunteers, pitavastatin Cmax and AUC were 10 and 30% higher, respectively, in the elderly. This had no effect on the efficacy or safety of LIVALO in elderly subjects in clinical studies.

Renal Impairment

In patients with moderate renal impairment (glomerular filtration rate of 30 – 59 mL/min/1.73 m2) and end stage renal disease receiving hemodialysis, pitavastatin AUC0-inf is 102 and 86% higher than those of healthy volunteers, respectively, while pitavastatin Cmax is 60 and 40% higher than those of healthy volunteers, respectively. Patients received hemodialysis immediately before pitavastatin dosing and did not undergo hemodialysis during the pharmacokinetic study. Hemodialysis patients have 33 and 36% increases in the mean unbound fraction of pitavastatin as compared to healthy volunteers and patients with moderate renal impairment, respectively.

In another pharmacokinetic study, patients with severe renal impairment (glomerular filtration rate 15 – 29 mL/min/1.73 m2) not receiving hemodialysis were administered a single dose of LIVALO 4 mg. The AUC0-inf and the Cmax were 36 and 18% higher, respectively, compared with those of healthy volunteers. For both patients with severe renal impairment and healthy volunteers, the mean percentage of protein-unbound pitavastatin was approximately 0.6%.

The effect of mild renal impairment on pitavastatin exposure has not been studied.

Hepatic Impairment

The disposition of pitavastatin was compared in healthy volunteers and patients with various degrees of hepatic impairment. The ratio of pitavastatin Cmax between patients with moderate hepatic impairment (Child-Pugh B disease) and healthy volunteers was 2.7. The ratio of pitavastatin AUCinf between patients with moderate hepatic impairment and healthy volunteers was 3.8. The ratio of pitavastatin Cmax between patients with mild hepatic impairment (Child-Pugh A disease) and healthy volunteers was 1.3. The ratio of pitavastatin AUCinf between patients with mild hepatic impairment and healthy volunteers was 1.6. Mean pitavastatin t½ for moderate hepatic impairment, mild hepatic impairment, and healthy were 15, 10, and 8 hours, respectively.

Drug-Drug Interactions

The principal route of pitavastatin metabolism is glucuronidation via liver UGTs with subsequent formation of pitavastatin lactone. There is only minimal metabolism by the cytochrome P450 system.

Warfarin

The steady-state pharmacodynamics (international normalized ratio and prothrombin time ) and pharmacokinetics of warfarin in healthy volunteers were unaffected by the co-administration of LIVALO 4 mg daily. However, patients receiving warfarin should have their PT time or INR monitored when pitavastatin is added to their therapy.

Table 2. Effect of Co-Administered Drugs on Pitavastatin Systemic Exposure

Co-administered drug Dose regimen Change in
AUC*
Change in
Cmax*
Cyclosporine Pitavastatin 2 mg QD for 6 days + cyclosporine 2 mg/kg on Day 6 4.6 fold† 6.6 fold †
Erythromycin Pitavastatin 4 mg single dose on Day 4 + erythromycin 500 mg 4 times daily for 6 days 2.8 fold † 3.6 fold †
Rifampin Pitavastatin 4 mg QD + rifampin 600 mg QD for 5 days 29% 2.0 fold
Atazanavir Pitavastatin 4 mg QD + atazanavir 300 mg daily for 5 days 31% 60%
Darunavir/Ritonavir Pitavastatin 4mg QD on Days 1-5 and 12-16 + darunavir/ritonavir 800mg/100 mg QD on Days 6-16 ↓ 26% ↓ 4%
Lopinavir/Ritonavir Pitavastatin 4 mg QD on Days 1-5 and 2024 + lopinavir/ritonavir 400 mg/100 mg BID on Days 9 – 24 ↓ 20% ↓4 %
Gemfibrozil Pitavastatin 4 mg QD + gemfibrozil 600 mg BID for 7 days 45% 31%
Fenofibrate Pitavastatin 4 mg QD + fenofibrate 160 mg QD for 7 days 18% 11%
Ezetimibe Pitavastatin 2 mg QD + ezetimibe 10 mg for 7 days ↓ 2% ↓0.2%
Enalapril Pitavastatin 4 mg QD + enalapril 20 mg daily for 5 days 6% ↓ 7%
Digoxin Pitavastatin 4 mg QD + digoxin 0.25 mg for 7 days 4% ↓ 9%
Diltiazem LA Pitavastatin 4 mg QD on Days 1-5 and 1115 and diltiazem LA 240 mg on Days 6-15 10% 15%
Grapefruit Juice Pitavastatin 2 mg single dose on Day 3 + grapefruit juice for 4 days 15% ↓ 12%
Itraconazole Pitavastatin 4 mg single dose on Day 4 + itraconazole 200 mg daily for 5 days ↓ 23% ↓ 22%
*Data presented as x-fold change represent the ratio between co-administration and pitavastatin alone (i.e., 1-fold = no change). Data presented as % change represent % difference relative to pitavastatin alone (i.e., 0% = no change).
† Considered clinically significant
BID = twice daily; QD = once daily; LA = Long Acting

Table 3. Effect of Pitavastatin Co-Administration on Systemic Exposure to Other Drugs

Co-administered drug Dose regimen Change in
AUC*
Change in
Cmax*
Atazanavir Pitavastatin 4 mg QD + atazanavir 300 mg daily for 5 days 6% 13%
Darunavir Pitavastatin 4mg QD on Days 1-5 and 12-16 + darunavir/ritonavir 800mg/100 mg QD on Days 6-16 3% 6%
Lopinavir Pitavastatin 4 mg QD on Days 1-5 and 2024 + lopinavir/ritonavir 400 mg/100 mg BID on Days 9 – 24 ↓ 9% ↓ 7%
Ritonavir Pitavastatin 4 mg QD on Days 1-5 and 2024 + lopinavir/ritonavir 400 mg/100 mg BID on Days 9 – 24 ↓ 11% ↓ 11%
Ritonavir Pitavastatin 4mg QD on Days 1-5 and 12-16 + darunavir/ritonavir 800mg/100 mg QD on Days 6-16 8% 2%
Enalapril Pitavastatin 4 mg QD + enalapril 20 mg daily for 5 days Enalapril 12% 12%
Enalaprilat ↓ 1% ↓ 1%
Warfarin Individualized maintenance dose of warfarin (2 -7 mg) for 8 days + pitavastatin 4 mg QD for 9 days R-warfarin 7% 3%
S-warfarin 6% 3%
Ezetimibe Pitavastatin 2 mg QD + ezetimibe 10 mg for 7 days 9% 2%
Digoxin Pitavastatin 4 mg QD + digoxin 0.25 mg for 7 days ↓ 3% ↓ 4%
Diltiazem LA Pitavastatin 4 mg QD on Days 1-5 and 1115 and diltiazem LA 240 mg on Days 6-15 ↓ 2% ↓ 7%
Rifampin Pitavastatin 4 mg QD + rifampin 600 mg QD for 5 days ↓ 15% ↓ 18%
*Data presented as % change represent % difference relative to the investigated drug alone (i.e., 0% = no change).
BID = twice daily; QD = once daily; LA = Long Acting

Animal Toxicology And/Or Pharmacology

Central Nervous System Toxicity

CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with several other members of this drug class. A chemically similar drug in this class produced dose-dependent optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in dogs, at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose. Wallerian degeneration has not been observed with pitavastatin. Cataracts and lens opacities were seen in dogs treated for 52 weeks at a dose level of 1 mg/kg/day (9 times clinical exposure at the maximum human dose of 4 mg/day based on AUC comparisons).

Clinical Studies

Primary Hyperlipidemia Or Mixed Dyslipidemia

Dose-Ranging Study

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was performed to evaluate the efficacy of LIVALO compared with placebo in 251 patients with primary hyperlipidemia (Table 4). LIVALO given as a single daily dose for 12 weeks significantly reduced plasma LDL-C, TC, TG, and Apo-B compared to placebo and was associated with variable increases in HDL-C across the dose range.

Table 4. Dose-Response in Patients with Primary Hypercholesterolemia (Adjusted Mean % Change from Baseline at Week 12)

Active-Controlled Study With Atorvastatin (NK-104-301)

LIVALO was compared with the HMG-CoA reductase inhibitor atorvastatin in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority Phase 3 study of 817 patients with primary hyperlipidemia or mixed dyslipidemia. Patients entered a 6-to 8-week wash-out/dietary lead-in period and then were randomized to a 12-week treatment with either LIVALO or atorvastatin (Table 5). Non-inferiority of pitavastatin to a given dose of atorvastatin was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

Table 5. Response by Dose of LIVALO and Atorvastatin in Patients with Primary Hyperlipidemia or Mixed Dyslipidemia (Mean % Change from Baseline at Week 12)

Active-Controlled Study With Simvastatin (NK-104-302)

LIVALO was compared with the HMG-CoA reductase inhibitor simvastatin in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority Phase 3 study of 843 patients with primary hyperlipidemia or mixed dyslipidemia. Patients entered a 6-to 8-week wash-out/dietary lead-in period and then were randomized to a 12 week treatment with either LIVALO or simvastatin (Table 6). Non-inferiority of pitavastatin to a given dose of simvastatin was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

Table 6. Response by Dose of LIVALO and Simvastatin in Patients with Primary Hyperlipidemia or Mixed Dyslipidemia (Mean % Change from Baseline at Week 12)

Active-Controlled Study With Pravastatin In Elderly (NK-104-306)

LIVALO was compared with the HMG-CoA reductase inhibitor pravastatin in a randomized, multicenter, double-blind, double-dummy, parallel group, active-controlled non-inferiority Phase 3 study of 942 elderly patients (≥65 years) with primary hyperlipidemia or mixed dyslipidemia. Patients entered a 6-to 8-week washout/dietary lead-in period, and then were randomized to a once daily dose of LIVALO or pravastatin for 12 weeks (Table 7). Non-inferiority of LIVALO to a given dose of pravastatin was assumed if the lower bound of the 95% CI for the treatment difference was greater than -6% for the mean percent change in LDL-C.

Table 7. Response by Dose of LIVALO and Pravastatin in Patients with Primary Hyperlipidemia or Mixed Dyslipidemia (Mean % Change from Baseline at Week 12)

Active-Controlled Study With Simvastatin In Patients With ≥ 2 Risk Factors For Coronary Heart Disease (NK-104-304)

LIVALO was compared with the HMG-CoA reductase inhibitor simvastatin in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority Phase 3 study of 351 patients with primary hyperlipidemia or mixed dyslipidemia with ≥2 risk factors for coronary heart disease. After a 6-to 8-week wash-out/dietary lead-in period, patients were randomized to a 12-week treatment with either LIVALO or simvastatin (Table 8). Non-inferiority of LIVALO to simvastatin was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

Table 8. Response by Dose of LIVALO and Simvastatin in Patients with Primary Hyperlipidemia or Mixed Dyslipidemia with ≥2 Risk Factors for Coronary Heart Disease (Mean % Change from Baseline at Week 12)

Active-Controlled Study With Atorvastatin In Patients With Type II Diabetes Mellitus (NK-104-305)

LIVALO was compared with the HMG-CoA reductase inhibitor atorvastatin in a randomized, multicenter, double-blind, double-dummy, parallel group, active-controlled, non-inferiority Phase 3 study of 410 subjects with type II diabetes mellitus and combined dyslipidemia. Patients entered a 6-to 8-week washout/dietary lead-in period and were randomized to a once daily dose of LIVALO or atorvastatin for 12 weeks. Non-inferiority of LIVALO was considered to be demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

Table 9. Response by Dose of LIVALO and Atorvastatin in Patients with Type II Diabetes Mellitus and Combined Dyslipidemia (Mean % Change from Baseline at Week 12)

Treatment N LDL-C Apo-B TC TG HDL-C non-HDL-C
LIVALO
4 mg daily
274 -41 -32 -28 -20 7 -36
Atorvastatin
20 mg daily
136 -43 -34 -32 -27 8 -40
Atorvastatin
40 mg daily
Not Studied
Atorvastatin
80 mg daily
Not Studied

The treatment differences in efficacy in LDL-C change from baseline between LIVALO and active controls in the Phase 3 studies are summarized in Figure 1.

Figure 1. Treatment Difference in Adjusted Mean Percent Change in LDL-C

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Common Brand(s): Livalo, Zypitamag Pitavastatin is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. It belongs to a group of drugs known as “statins.” It works by reducing the amount of cholesterol made by the liver. Lowering “bad” cholesterol and triglycerides and raising “good” cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Uses

  • hypercholesterolemia
  • mixed hyperlipidemia
  • hyperlipidemia

Usage Instructions

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take pitavastatin at least 1 hour before or at least 4 hours after taking these medications. These products can react with pitavastatin, preventing its full absorption. Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick. It is very important to continue to follow your doctor’s advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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