DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Table 3: Details of Specific Labelling RequirementsNO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)1. 5-ALPHA REDUCTASE INHIBITOR (5-ARI)The following statement shall be included in the package inserts of productscontaining 5-ARI:1.1 PRODUCT CONTAINING FINASTERIDE 5MGWARNINGS AND PRECAUTIONSIncreased Risk of High-Grade Prostate CancerMen aged 55 and over with a normal digital rectal examination and PSA≤3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year ProstateCancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar resultswere observed in a 4-year placebo-controlled clinical trial with another 5-alpha reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs0.5% placebo).5-alpha reductase inhibitors may increase the risk of development of highgradeprostate cancer. Whether the effect of 5-alpha reductase inhibitorsto reduce prostate volume, or study-related factors, impacted the results ofthese studies has not been established.Increased Risk of Breast CancerBreast cancer has been reported in men taking finasteride 5 mg during thepost-marketing period. Physicians should instruct their patients to promptlyreport any changes in their breast tissue such as lumps, pain,gynaecomastia or nipple discharge.ADVERSE EVENTS: POST MARKETING EXPERIENCEMale breast cancer1.2 PRODUCT CONTAINING FINASTERIDE 1MGWARNINGS AND PRECAUTIONSIncreased Risk of High-Grade Prostate CancerMen aged 55 and over with a normal digital rectal examination and PSA≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of[Brand Name]) in the 7-year Prostate Cancer Prevention Trial (PCPT) hadan increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8%vs placebo 1.1%). Similar results were observed in a 4-year placebocontrolledclinical trial with another 5-alpha reductase inhibitorNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 356
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)(dutasteride, AVODART) (1% dutasteride vs 0.5% placebo).5-alpha reductase inhibitors may increase the risk of development of highgradeprostate cancer. Whether the effect of 5-alpha reductase inhibitorsto reduce prostate volume, or study-related factors, impacted the results ofthese studies has not been established.Increased Risk of Breast CancerBreast cancer has been reported in men taking finasteride 1 mg during thepost-marketing period. Physicians should instruct their patients to promptlyreport any changes in their breast tissue such as lumps, pain,gynaecomastia or nipple discharge.ADVERSE EVENTS: POST MARKETING EXPERIENCEMale breast cancer1.3 PRODUCT CONTAINING DUTASTERIDEWARNINGS AND PRECAUTIONSIncreased Risk of High-Grade Prostate CancerIn men aged 50 to 75 years with a prior negative biopsy for prostatecancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL takingAVODART in the 4-year Reduction by Dutasteride of Prostate CancerEvents (REDUCE) trial, there was an increased incidence of Gleasonscore 8-10 prostate cancer compared with men taking placebo(AVODART 1.0% versus placebo 0.5%). In a 7-year placebo-controlledclinical trial with another 5-alpha reductase inhibitor (finasteride 5 mg,PROSCAR), similar results for Gleason score 8-10 prostate cancer wereobserved (finasteride 1.8% versus placebo 1.1%).5-alpha reductase inhibitors may increase the risk of development of highgradeprostate cancer. Whether the effect of 5-alpha reductase inhibitorsto reduce prostate volume, or studyrelated factors, impacted the results ofthese studies has not been established.Reference:a) Circular Bil (19) dlm BPFK/PPP/01/03 Jld 1: Direktif untuk Memuatkan KenyataanAmaran Berkaitan dengan Risiko High-Grade Prostate Cancer dalam SisipBungkusan Semua Produk 5-Arib) Circular Bil (64) dlm BPFK/PPP/01/03 Jld 1: Direktif untuk Memuatkan KenyataanAmaran Berkaitan dengan Risiko Kanser Payudara Di Kalangan Pesakit Lelaki dalamSisip Bungkusan Semua Produk Yang Mengandungi FinasterideNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 357
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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Page 306 and 307: Drug Registration Guidance Document
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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