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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.

This website is intended for Healthcare Professionals in the United Kingdom and Ireland. To access prescribing information for Merck Neurology medicines please click here.

UK&IE/CLA/0519/0045(1)a - September 2019

© 2017 Merck Serono Ltd.Registered Address: Merck Serono Ltd. 5 New Square, Bedfont Lakes Business Park, Feltham, TW14 8HA, United Kingdom
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Tel: +44 (0) 20 8818 7373 | Email: medinfo.uk@merckgroup.com
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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.