Table 3

Guidelines and labelling regulations for Cfz

Authority	Region	Indication	Adverse effects	Off-label use	Recommendation for Cfz in TB use
WHO56 57	Global	MDR-TB and XDR-TB	Gastrointestinal intolerance	Named patient basis on ‘exceptional’ grounds	2011: ‘May be used but not included among drugs making up the standard regimen’ 2008: ‘Only if additional drugs are needed to bring the total to four’
WHO58 59	Global	Leprosy and severe ENL reactions in leprosy	Discolouration, ichthyosis	Named patient basis on ‘exceptional’ grounds	‘…In the treatment of multidrug resistant tuberculosis (MDR TB)…WHO has found no evidence of its effectiveness for these forms of treatment’58
Food and Drug Administration60	USA	Lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by ENL	Skin pigmentation, gastrointestinal, conjunctival and corneal pigmentation, discolouration of urine, faeces, sputum and sweat	Single-patient treatment investigational new drug protocol	Not stated