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MAVENCLAD® indications and contraindications

MAVENCLAD® INDICATIONS AND CONTRAINDICATIONS

MAVENCLAD®: for patients with highly active relapsing multiple sclerosis

MAVENCLAD® is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.1

In the CLARITY trial this included:

  • Patients with 1 relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other DMDs
  • Patients with 2 or more relapses in the previous year, whether on DMD treatment or not

Contraindications to MAVENCLAD®1

  • Moderate or severe renal impairment (creatinine clearance <60 mL/min)
  • Hypersensitivity to cladribine or any excipient listed on the Summary of Product Characteristics (SPC)
  • HIV infection
  • Active chronic infection (tuberculosis or hepatitis)
  • Immunocompromised patients, including those receiving immunosuppressive or myelosuppressive therapy
  • Active malignancy
  • Pregnancy and breast-feeding

Refer to the summary of product characteristics for complete prescribing information

VIEW REFERENCES

1. MAVENCLAD® Summary of Product Characteristics. Merck.
2. Giovannoni G, et al. N Engl J Med. 2010;362:416–26.
3. Giovannoni G, et al. N Engl J Med. 2010;362:416–26 (Supplementary information).
4. Giovannoni G, et al. Mult Scler. 2018;24:1594–1604.
5. Data on file CLAD005
6. Montalban X, et al. AAN. 2016;[P3.029].
7. Leist TP, et al. Lancet Neurol. 2014;13:257–67.
8. PREMIERE Clinical trials registry. Available at: https://clinicaltrials.gov/ct2/show/NCT01013350 [Accessed 19th November 2018].
9. Baker D, et al. Neurol Neuroimmunol Neuroinflamm. 2017;4:e360.
10. Soelberg-Sørensen P, et al. ENS. 2009;[P359].
11. Soelberg-Sørensen P, et al. ENS. 2010;[P442].
12. Giovannoni G. Neurotherapeutics. 2017;14:874-7.
13. Giovannoni G. Curr Opin Neurol. 2018;31:233–43.
14. Scolding N, et al. Pract Neurol. 2015;15:273–9.
15. Cook S, et al. AAN. 2016;[P3.058].
16. Giovannoni G, et al. Lancet Neurol. 2011;10:329–37.
17. Giovannoni G, et al. Mult Scler. 2018;doi: 10.1177/1352458518771875.
18. Giovannoni G, et al. ECTRIMS. 2017;[P1143].
19. Alemtuzumab Summary of Product Characteristics. Sanofi Genzyme.
20. Natalizumab Summary of Product Characteristics. Biogen.
21. Ocrelizumab Summary of Product Characteristics. Roche.
22. Cook S, et al. EAN. 2017;[P0543].
23. Cook S, et al. Mult Scler. 2011;17:578–93.
24. Cook S, et al. ECTRIMS-ACTRIMS. 2017;[P1142].
25. Galazka A, et al. ECTRIMS-ACTRIMS. 2017;[P1878].
26. MAVENCLAD® European Public Assessment Report, September 2017.
27. Soelberg-Sørensen P, et al. EAN. 2017;[EP3120]
28. Data on File, CLAD001 – Incidence of Lymphopenia, June 2018.
29. Pakpoor J, et al. Neurol Neuroimmunol Neuroinflamm. 2015;2:e158.
30. Stuve O, et al. ECTRIMS. 2017;[P690].
31. Soelberg-Sørensen P, et al. ECTRIMS. 2017;[P1141].
32. Cvetanovich GL, Hafler DA. Curr Opin Immunol. 2010;22:753–60.
33. Ceronie B, et al. J Neurol. 2018;265:1199–1209.
34. Leist TP, et al. Clin Neuropharmacol. 2011;34:28–35.
35. Giovanni G, et al. Mult Scler. 2017; doi:10.1177/1352458517727603.
36. Giovanni G, et al. EAN. 2017; [PO542].
37. Giovanni G, et al. ECTRIMS. 2016.

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Reporting Adverse Events
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. In the Republic of Ireland information can be found at www.hpra.ie. Adverse events should also be reported to Merck Serono Limited – Tel: +44(0)20 8818 7373 or email: medinfo.uk@merckgroup.com.
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