DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)BOXED WARNING- Exposure to gadolinium – based contrast agents (GBCAs) increasesthe risk for Nephrogenic Systemic Fibrosis (NSF) in patients with:acute or chronic severe renal insufficiency (glomerular filtrationrate < 30mL/min/1.73m²), oracute renal insufficiency of any severity due to the hepato-renalsyndrome or in the perioperative liver transplantation period.- NSF is a debilitating and sometimes fatal disease affecting the skin,muscle, and internal organs- Avoid use of GBCAs unless the diagnotic information is essential andnot available with non-contrast enhanced magnetic resonance imaging(MRI).- Screen all patients for renal dysfunction by obtaining a history and/ orlaboratory tests.- When administering a GBCA, do not exceed the dose recommendedin product labelling. Allow sufficient time for elimination of the GBCAprior to any readministration.WARNINGAmong the factors that may increase the risk for NSF are repeated orhigher than recommended doses of a GBCA.For patients receiving haemodialysis, healthcare professionals mayconsider prompt haemodialysis following GBCA administration in orderto enhance the contrast agent‟s elimination. However, it is unknown ifhaemodialysis prevents NSF.Determine the renal function of patients by obtaining a medical historyof conducting laboratory tests that measure renal function prior to usingGBCA.The risk, if any, for developing NSF among patients with mild tomoderate renal insufficiency or normal renal function is unknown.Post-marketing reports have identified the development of NSFfollowing single and multiple administrations of GBCAs.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 384