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Safety information on Cladribine Tablets from clinical trials and post-approval experience

We are committed to safety communication

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.

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References

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

  1. Giovannoni G et al. N Engl J Med 2010;362:416–26
  2. Giovannoni G et al. Mult Scler J 2018;24:1594–604
  3. Montalban X et al. Neurol Neuroimmunol Neuroinflamm 2018;5:e477
  4. Leist T et al. Lancet Neurol 2014;13:257–67
  5. PREMIERE registry, https://clinicaltrials.gov/ct2/show/NCT01013350
  6. Cook S et al. ECTRIMS 2019 [P1390]
  7. MAVENCLAD® US Prescribing Information, April 2019 [Section 6.1]
  8. MAVENCLAD® EPAR, https://www.ema.europa.eu/en/documents/assessment-report/mavenclad-epar-public-assessment-report_en.pdf  [Accessed 17 March 2020]

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

 

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