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Livalo

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Livalo

Livalo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Livalo (pitavastatin) is used to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels. It is a statin drug. Common side effects include muscle pain, back pain, joint pain and constipation.

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. Livalo may interact with cyclosporine, erythromycin, rifampin, gemfibrozil, other fibrates, niacin, or warfarin. Tell your doctor all medications you are taking. 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. Breast-feeding is not recommended while taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Livalo in Detail - Patient Information: Side Effects

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

Stop taking pitavastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;
  • confusion, memory problems;
  • fever, unusual tiredness, and dark colored urine;
  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild muscle pain;
  • back pain, pain in your arms or legs;
  • diarrhea, constipation; or
  • mild skin rash.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Livalo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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

Adverse Reactions* Placebo
N= 208
LIVALO 1 mg
N=309
LIVALO 2 mg
N=951
LIVALO 4 mg
N=1540
Back Pain 2.90% 3.90% 1.80% 1.40%
Constipation 1.90% 3.60% 1.50% 2.20%
Diarrhea 1.90% 2.60% 1.50% 1.90%
Myalgia 1.40% 1.90% 2.80% 3.10%
Pain in extremity 1.90% 2.30% 0.60% 0.90%
* Adverse reactions by MedDRA preferred term.

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.

In controlled clinical studies and their open-label extensions, 3.9% (1 mg), 3.3% (2 mg), and 3.7% (4 mg) of pitavastatin-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).

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

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 and muscle spasms.

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).

Read the entire FDA prescribing information for Livalo (Pitavastatin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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