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Livalo

Last reviewed on RxList: 10/9/2020
Livalo Side Effects Center

What Is Livalo?

Livalo (pitavastatin) is a statin drug used to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

What Are Side Effects for Livalo?

Common side effects of Livalo include:

Dosage for Livalo

The dose range for Livalo is 1 to 4 mg orally once daily. The recommended starting dose is 2 mg and the maximum dose is 4 mg.

What Drugs, Substances, or Supplements Interact with Livalo?

Livalo may interact with:

Tell your doctor all medications you are taking.

Livalo During Pregnancy and Breastfeeding

Livalo is not recommended for use during pregnancy, as it may cause fetal harm. It is not known whether Livalo passes into breast milk, however, it has been shown that a small amount of another drug in this class passes into breast milk and that drug has the potential to cause serious adverse reactions in nursing infants. Breastfeeding is not recommended while taking this medication.

Additional Information

Our Livalo (pitavastatin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Livalo Consumer Information

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

In rare cases, pitavastatin 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, or 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 side effects may include:

  • 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.

Read the entire detailed patient monograph for Livalo (Pitavastatin)

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Livalo Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in other sections of the labeling:

  • Myopathy and Rhabdomyolysis [see WARNINGS AND PRECAUTIONS]
  • Immune-Mediated Necrotizing Myopathy [see WARNINGS AND PRECAUTIONS]
  • Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS]
  • Increases in HbA1c and Fasting Serum Glucose Levels [see WARNINGS AND PRECAUTIONS].

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 And Mixed Dyslipidemia

In 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 adult patients with primary hyperlipidemia or mixed dyslipidemia 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 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.

In controlled clinical studies and their open-label extensions, 3.9% (1 mg), 3.3% (2 mg), and 3.7% (4 mg) of LIVALO-treated patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg).

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 ( ≥ 2% and ≥ placebo) in Adult Patients with Primary Hyperlipidemia and Mixed Dyslipidemia in Studies up to 12 Weeks

Adverse Reactions Placebo
(n= 208) %
LIVALO 1 mg
(n=309) %
LIVALO 2 mg
(n=951) %
LIVALO 4 mg
(n=1540) %
Back Pain 2.9 3.9 1.8 1.4
Constipation 1.9 3.6 1.5 2.2
Diarrhea 1.9 2.6 1.5 1.9
Myalgia 1.4 1.9 2.8 3.1
Pain in extremity 1.9 2.3 0.6 0.9

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

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

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

Adverse Reactions In Adult HIV-Infected Patients With Dyslipidemia

In a double-blind, randomized, controlled, 52-week trial, 252 HIV-infected patients with dyslipidemia were treated with either LIVALO 4 mg 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 (ULN), which resolved spontaneously. Four patients (3%) treated with LIVALO had at least one ALT value exceeding 3 times but less than 5 times the 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.

Adverse Reactions In Pediatric Patients Aged 8 Years And Older With HeFH

In a 12-week, double-blind, placebo-controlled trial of LIVALO 1 mg, 2 mg, and 4 mg once daily in 82 pediatric patients 8 years to 16 years of age with HeFH and a 52-week open-label trial in 85 pediatric patients with HeFH, the safety profile was similar to that observed in the adult population.

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.

Gastrointestinal disorders: abdominal discomfort, abdominal pain, dyspepsia, nausea

General disorders: asthenia, fatigue, malaise, dizziness

Hepatobiliary disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure

Immune system disorders: angioedema, immune-mediated necrotizing myopathy associated with statin use.

Metabolism and nutrition disorders: increases in HbA1c, fasting serum glucose levels

Musculoskeletal and connective tissue disorders: muscle spasms, myopathy, rhabdomyolysis

Nervous system disorders: hypoesthesia, peripheral neuropathy

Psychiatric disorders: insomnia, depression. Rare reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. Cognitive impairment was generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Reproductive system and breast disorders: erectile dysfunction

Respiratory, thoracic and mediastinal disorders: interstitial lung disease

Read the entire FDA prescribing information for Livalo (Pitavastatin)

Related Resources for Livalo

© Livalo Patient Information is supplied by Cerner Multum, Inc. and Livalo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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