Banner NPRA

               
Product Search   QUEST3+ System   Enquiries   Sitemap  

Erbitux® (Cetuximab): Importance of establishing wild type RAS status (exons 2,3,4 of KRAS and NRAS) before treatment in metastatic colorectal cancer (mCRC)

Kadar pengguna: 4 / 5

bintang aktifbintang aktifbintang aktifbintang aktifBintang tidak aktif
 

Date: 17 April 2014

Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals regarding the contraindication of Erbitux® involving additional mutations of RAS beyond KRAS Codons 12/13. Evidence of wild-type RAS (exons 2, 3 and 4 of KRAS and NRAS) status is required before initiating treatment with Erbitux®. RAS mutational status should be determined by an experienced laboratory using a validated test method. The contraindication for Erbitux® in combination with oxaliplatin-containing chemotherapy (e.g.FOLFOX) now includes all patients with mutant RAS or unknown RAS status. Merck (M) Sdn. Bhd. is updating the package insert to incorporate the new efficacy and safety updates. Please refer to the letter for further information.

(FOLFOX: oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid; KRAS: Kirsten Rat Sarcoma; NRAS: Neuroblastoma Rat Sarcoma)

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Selasa 03 Disember 2024, 10:01:04.
© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Search

Menu Utama