ThislabelmaynotbethelatestapprovedbyFDA.
Forcurrentlabelinginformation,pleasevisit/drugsatfda
NDA22-273/S-001
Page3
HIGHLIGHTSOFPRESCRIBINGINFORMATION
ThesehighlightsdonotincludealltheinformationneededtouseOforta?safely?Reducedoseby50%inpatientswithsevererenalimpairment(creatinine
andeffectively.SeefullprescribinginformationforOforta?.clearance30mL/min/1.73m2)
Oforta?(fludarabinephosphatetablets)forOralUse.DOSAGEFORMSANDSTRENGTHS
InitialU.S.Approval:1991
?10milligramtablets.(see3)
WARNING:CNSTOXICITY,HEMOLYTICANEMIA,ANDPULMONARY
TOXICITY
CONTRAINDICATIONS
Seefullprescribinginformationforcompleteboxedwarning.
?None
?Severecentralnervoussystemtoxicityoccurredin36%ofpatientstreatedwith
dosesapproximatelyfourtimesgreater(96mg/m2/dayfor5daysto7days)thantheWARNINGSANDPRECAUTIONS
recommendedintravenousdose.Thistoxicitywasseenin≤0.2%ofpatientstreated
attherecommendedintravenousdoselevels(25mg/m2).(5.1)?Severebonemarro