DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 360
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)2. ACE INHIBITORSThe following statement shall be included in the package inserts of productscontaining ACE inhibitors:WARNINGINCREASED RISK OF BIRTH DEFECTS, FOETAL AND NEONATALMORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCYUSE IN PREGNANCYINCREASED RISK OF BIRTH DEFECTS, FOETAL AND NEONATALMORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCYReference: Circular Bil (65) dlm BPFK/02/5/1.3: Produk yang Mengandungi 'ACE Inhibitors'3. ACETYLSALICYLIC ACID (ASPIRIN)For products containing Acetylsalicylic acid, the following warning shall beincluded on the labels in two languages (Bahasa Malaysia and English):AMARANTIDAK BOLEH DIBERI KEPADA KANAK-KANAK BERUMUR KURANGDARIPADA 16 TAHUN.WARNINGNOT TO BE GIVEN TO CHILDREN UNDER 16 YEARS OF AGE.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 361
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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