LIVALO Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
Kowa Pharmaceuticals America, Inc.
Λέξεις κλειδιά
66869-104 66869-204 66869-404
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1. Indications and Usage
LIVALO is indicated as an adjunctive therapy to diet in: Adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol ...
2. Dosage and Administration
2.1 General Dosage and Administration Information Take LIVALO orally once daily with or without food at the same time each day. Individualize the dose of LIVALO according to patient characteristics, goal ...
3. Dosage Forms and Strengths
<u>Tablets:</u> 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 ...
4. Contraindications
LIVALO is contraindicated in the following conditions: Known hypersensitivity to pitavastatin or any inactive ingredient in LIVALO. Hypersensitivity reactions including rash, pruritus, and urticaria have ...
5. Warnings and Precautions
5.1 Myopathy and Rhabdomyolysis LIVALO may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) above ten times the upper limit of normal) and rhabdomyolysis (with or without ...
6. Adverse Reactions
The following serious adverse reactions are discussed in other sections of the labeling: Myopathy and Rhabdomyolysis <em>[see Warnings and Precautions (5.1)]</em> Immune-Mediated Necrotizing Myopathy ...
6.1. Clinical Trials 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 ...
6.2. 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 ...
7. Drug Interactions
Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with LIVALO Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly ...
8.1. Pregnancy
Risk Summary LIVALO is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with LIVALO during pregnancy. Because ...
8.2. Lactation
Risk Summary LIVALO is contraindicated during breastfeeding <em>[see Contraindications (4)]</em>. There is no available information on the effects of the drug on the breastfed infant or the effects of ...
8.3. Females and Males of Reproductive Potential
Contraception Females LIVALO may cause fetal harm when administered to a pregnant woman <em>[see Use in Specific Populations (8.1)]</em>. Advise females of reproductive potential to use effective contraception ...
8.4. Pediatric Use
The safety and effectiveness of LIVALO as an adjunctive therapy to diet to reduce elevated TC, LDL-C, and Apo B in pediatric patients aged 8 years and older with HeFH have been established. Use of LIVALO ...
8.5. Geriatric Use
In controlled clinical studies, 1,209 (43%) patients were 65 years and older. No significant differences in efficacy or safety were observed between geriatric patients and younger patients. Advanced age ...
8.6. Renal Impairment
Renal impairment is a risk factor for myopathy and rhabdomyolysis. Due to the risk of myopathy, a dosage modification of LIVALO is recommended for adults with moderate and severe renal impairment (estimated ...
8.7. Hepatic Impairment
LIVALO is contraindicated in patients with active liver disease including unexplained persistent elevations of hepatic transaminase levels <em>[see Contraindications (4), Warnings and Precautions (5.3)] ...
10. Overdosage
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. ...
11. Description
LIVALO (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium <em>bis</em>{(3R, 5S, 6<em>E</em>)7[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. ...
12.1. Mechanism of Action
Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic pathway ...
12.2. Pharmacodynamics
Cardiac Electrophysiology 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 ...
12.3. Pharmacokinetics
Absorption Pitavastatin peak plasma concentrations are achieved about 1 hour after oral administration. Both C<sub>max</sub> and AUC<sub>0-inf</sub> increased in an approximately dose-proportional manner ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 92-week carcinogenicity study in mice given pitavastatin, at the maximum tolerated dose of 75 mg/kg/day with systemic maximum exposures (AUC) 26 times the clinical maximum exposure at 4 mg daily, ...
13.2. 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 ...
14. Clinical Studies
14.1 Primary Hyperlipidemia or Mixed Dyslipidemia in Adult Patients Active-Controlled Study with Atorvastatin (Study 301) LIVALO was compared with Atorvastatin Calcium Tablets (referred to as atorvastatin) ...
16.1. How Supplied
LIVALO tablets are supplied as follows: Tablet Strength Package Size Tablet Description NDC 1 mg Bottle of 90 Round white film-coated tablet debossed KC on one face and 1 on the reverse 66869-104-90 ...
16.2. Storage and Handling
Store at room temperature between 15°C and 30°C (59° to 86°F) [see USP]. Protect from light.
17. Patient Counseling Information
The patient should be informed of the following: Myopathy and Rhabdomyolysis Advise patients that LIVALO may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain ...