The safety of treatment with Cladribine Tablets was assessed in the clinical trial program,1–5 including the CLARITY1 and CLARITY Extension2 studies in patients with relapsing multiple sclerosis (RMS).
Ongoing updates contain data from patients with post-approval experience.
aIn CLARITY, ONWARD and ORACLE-MS; bIn total, 21 clinical studies have been conducted with cladribine – 12 involving oral cladribine and 9 involving parenteral cladribine, consisting of 9509 patient-years of exposure (cumulative to May 2017)8
In the United States, the US Prescribing Information is the primary source of information on the known and potential risks associated with treatment with Cladribine Tablets
Indication
Cladribine Tablets are indicated for the treatment of relapsing forms of MS, to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of the safety profile, use of Cladribine Tablets is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS
Limitations of use: Cladribine Tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile