Generic Name
Pitavastatin
Brand Names
Livalo, Zypitamag
FDA approval date: February 03, 2017
Classification: HMG-CoA Reductase Inhibitor
Form: Tablet
What is Livalo (Pitavastatin)?
LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia . LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia .
Approved To Treat
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Brand Information
Livalo (pitavastatin calcium)
1INDICATIONS AND USAGE
LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
- Adults with primary hyperlipidemia.
- Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 1 mg: Round white tablet, debossed "KC" on one side and "1" on the other side.
- 2 mg: Round white tablet, debossed "KC" on one side and "2" on the other side.
- 4 mg: Round white tablet, debossed "KC" on one side and "4" on the other side.
3CONTRAINDICATIONS
LIVALO is contraindicated in the following conditions:
- Concomitant use of cyclosporine
- Acute liver failure or decompensated cirrhosis
- Hypersensitivity to pitavastatin or any excipents in LIVALO. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with LIVALO
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in other sections of the labeling:
- Myopathy and Rhabdomyolysis
- Immune-Mediated Necrotizing Myopathy
- Hepatic Dysfunction
- Increases in HbA1c and Fasting Serum Glucose Levels
4.1Clinical 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.
4.2Postmarketing 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. There have been rare reports of new onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered. 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).
- Psychiatric disorders: insomnia, depression
- Reproductive system and breast disorders: erectile dysfunction
- Respiratory, thoracic and mediastinal disorders: interstitial lung disease
- Skin and subcutaneous tissue disorders: lichen planus
5DRUG 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
6OVERDOSAGE
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.
7DESCRIPTION
LIVALO (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor.
The chemical name for pitavastatin is (+)monocalcium
The empirical formula for pitavastatin is C
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.
8HOW SUPPLIED/STORAGE AND HANDLING
LIVALO tablets are supplied as follows:
9PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
NDC 66869-104-90
Livalo
1 mg*
Rx Only
Kowa
10PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label
NDC 66869-204-90
Livalo
2 mg*
Rx Only
Kowa
11PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label
NDC 66869-404-90
Livalo
4 mg*
Rx Only
Kowa
