リバロ錠 1 mg, リバロ錠 2 mg, - pmda.go.jp

1 1 mg, 2 mg, OD 1 mg, OD 2 mg 1 1 mg 2 mg OD 1 mg OD 2 mg 1 ( 1) 2 .. 4 .. 4 .. 4 .. 4 .. 5 .. 7 .. 8 3 HMG-CoA Hydroxymethylglutaryl-CoA FH Familial Hypercholesterolemia LDL-C Low Density Lipoprotein Cholesterol HDL-C High Density Lipoprotein Cholesterol OD Oral Disintegrant PDCO Paediatric Committee PIP Paediatric Investigation Plan 4 HMG-CoA HMG-CoA

2 LDL-C HDL-C 1 mg/ 2 mg/ 4 mg/ 1 2 mg/ LDL-C 4 mg/ 1 mg 2mg 2003 7 17 9 2015 2 43 2003 7 17 2mg 2007 9 28 2012 1 18 4 mg OD 1 mg OD 2 mg 2013 2 15 OD 4 mg 2013 8 15 2013 2 28 2009 8 3 16 2008 8 2010 8 10 5 FH FH 1)2)

3 2008 8 EC1901/2006 PDCO PIP [ 12 ] [ ] 2 (1) 12 6 16 NK-104 1 mg 2 mg 4 mg 12 12 LOCF LDL-C NK-104 1 mg NK-104 2 mg NK-104 4 mg 8 12 1 NK-104 1 mg ng/mL 2 mg ng/mL 4 mg ng/mL NK-104 1 mg 2 mg 4 mg 18/26 16/27 11/26 15/27 1 mg 2 mg 4 mg 4/26 4/27 4/26 4/27 2 mg 1 6 2 mg 1 4 mg 1 (2)

4 6 16 NK-104 52 1 mg LDL-C 4 mg 52 LOCF LDL-C 75/112 10/112 4 mg 1 mg 1 2 mg 2 mg 1 FH FH FH FH [ III NK-104-PH-01 ] NK-104-PH-02 NK-104-PH-01 (1) III NK-104-PH-01 10 15 FH NK-104 1 mg 2 mg 52 8 12 LDL-C NK-104 1 mg NK-104 2 mg 1 mg 2 mg LDL-C 7 8 12 NK-104 1 1 mg ng/mL 2 mg ng/mL NK-104 1 mg 100% 7/7 2 mg 5/7 1 mg 1 III (NK-104-PH-01) 12 ( ) ( )

5 Source NK-104-PH-01 NK-104 FH FH 1 mg 2 mg FH 1 2mg 1 1 LDL- 1 4mg 1 2mg 1 1 LDL- 8 1 4mg 10 1mg 1 1 LDL- 1 2mg 1) Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents; National Heart, Lung, and Blood Institute. Expert Panel on Integrated Guidelines or Cardiovascular Health and Risk Reduction in Children and Adolescents: Summary Report.

6 Pediatrics. 2011 Dec;128 Suppl5:S213-56. 2) Nordestgaard BG, Chapman MJ, Humphries SE, Ginsberg HN, Masana L, Descamps OS, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population:guidance for clinicians to prevent coronary heart disease: Consensus Statement of the European Atherosclerosis Society. Eur Heart J. 2013 Dec;34(45):3478-90a. 1 1 mg 2 mg OD 1 mg OD 2 mg 1 ( 1) 2 ..3 ..3 ..6 OD 2015 2 43 20 2010 7 16 OD 4 2015 2 *1 Livalo 2005 1 (1,2mg)/ 2012 5 (4mg) 1mg/2mg/4mg *1 Livalo 2007 11 1mg( )/2mg *1 2008 9 1mg( )

7 /2mg *1 Livalo 2009 8 1mg/2mg/4mg *2 Livazo 2010 8 1mg/2mg/4mg *2 Livazo 2010 8 1mg/2mg/4mg *1, *2 Livazo/Alipza 2010 8 1mg/2mg/4mg *2 Trolise 2010 10 1mg/2mg/4mg *2 Livazo 2010 10 1mg/2mg/4mg *2 Livazo 2010 11 1mg/2mg/4mg *2 Livazo 2010 11 1mg/2mg/4mg *1, *2 Livazo/Alipza 2010 11 1mg/2mg/4mg *1 Livazo 2010 12 2mg/4mg *2 Verliret/Kadosyn 2010 12 1mg/2mg/4mg *2 Livazo 2010 12 1mg/2mg/4mg *1 2011 1 (2mg)/ 2013 2 (4mg) 2mg/4mg *2 Livazo 2011 2 1mg/2mg/4mg Redevant 2011 2 1mg/2mg/4mg *2 Trolise 2011 3 1mg/2mg/4mg *1, *2 Livazo 2011 3 1mg/2mg/4mg *2 Livazo 2011 6 1mg/2mg/4mg *1 Redevant 2011 7 1mg( )/ 2mg/4mg Redevant 2011 9 1mg( )/ 2mg/4mg *2 Livazo 2011 11 1mg/2mg/4mg Livalo 2011 11 1mg/2mg/4mg *1 Livalo 2011 11 2mg *1 Livazo 2012 1 1mg/2mg/4mg Redevant 2012 4 1mg( )/ 2mg/4mg Livazo 2012 5 1mg/2mg/4mg *1 Redevant 2012 4 (1mg)/ 2012 5 (2,4mg) 1mg( )/ 2mg/4mg *2 Livazo 2012 6 1mg/2mg/4mg 5 2015 2 *1 Livazo 2012 7 1mg/2mg/4mg *1 Livalo 2012 9 1mg( )/ 2mg/4mg Livazo 2013 2 1mg/2mg/4mg Redevant 2013 7 1mg( )/ 2mg/4mg Redevant 2013 7 (1mg)/ 2013 8 (2,4mg) 1mg( )/ 2mg/4mg *1 Redevant 2013 8 1mg( )

8 / 2mg/4mg *1 Livazo 2013 9 2mg/4mg *1 Livazo 2013 12 2mg/4mg Redevant 2014 2 1mg( )/ 2mg/4mg Livazo 2014 5 2mg/4mg *1 Livazo 2014 6 2mg/4mg *1 Livazo 2014 6 2mg/4mg *1 2015 2 *2 2013 10 2012 8 CCDS 2014 4 1 LIVALO (pitavastatin) Tablet 1 mg, 2 mg, and 4 mg Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117 Package Insert Product Labeling Version of October 2013 Version Livalo (pitavastatin) Tablet 1 mg, 2 mg, 4 mg Kowa Pharmaceuticals America, Inc. V - October 2013 - LIV-RA-0083 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese highlights do not include all the information needed to useLIVALO safely and effectively.

9 See full prescribing information (pitavastatin) Tablet, Film Coated for Oral useInitial Approval: 2009 RECENT MAJOR CHANGES None INDICATIONS AND USAGE LIVALO is a HMG-CoA reductase inhibitor indicated for: Patients with primary hyperlipidemia or mixed dyslipidemia as anadjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),triglycerides (TG), and to increase high-density lipoprotein cholesterol(HDL-C) ( )Limitations of Use ( ): Doses of LIVALO greater than 4 mg once daily were associated with anincreased risk for severe myopathy in premarketing clinical studies. Do notexceed 4 mg once daily dosing of LIVALO. The effect of LIVALO on cardiovascular morbidity and mortality has notbeen determined. LIVALO has not been studied in Fredrickson Type I, III, and Vdyslipidemias.

10 DOSAGE AND ADMINISTRATION LIVALO can be taken with or without food, at any time of day ( ) DoseRange: 1 mg to 4 mg once daily ( ) Primary hyperlipidemia and mixed dyslipidemia: Starting dose 2 lowering of LDL-C is insufficient, the dosage may be increased to amaximum of 4 mg per day. ( ) Moderate and severe renal impairment (glomerular filtration rate 30 59 and 15 - 29 mL/ m2, respectively) as well as end-stage renaldisease on hemodialysis: Starting dose of 1 mg once daily and maximumdose of 2 mg once daily ( ) DOSAGE FORMS AND STRENGTHS Tablets: 1 mg, 2 mg, and 4 mg (3) CONTRAINDICATIONS Known hypersensitivity to product components (4) Active liver disease, which may include unexplained persistent elevations inhepatic transaminase levels (4) Women who are pregnant or may become pregnant (4, ) Nursing mothers (4, ) Co-administration with cyclosporine (4, , ) WARNINGS AND PRECAUTIONS Skeletal muscle effects ( , myopathy and rhabdomyolysis): Risksincrease in a dose-dependent manner, with advanced age ( 65), renalimpairment, and inadequately treated hypothyroidism.