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Minimal Monitoring

MAVENCLAD® HAS LOW ADMINISTRATION AND MONITORING REQUIREMENTS, WHILE DISEASE CONTROL* CAN BE SUSTAINED FOR UP TO FOUR YEARS1

Lymphocyte monitoring in Years 1-4 with MAVENCLAD®


Click here for a list of contraindications

Additional pre-treatment assessments required at year 1 and year 21

  • A baseline cranial MRI scan (usually within 3 months before initiation)
  • Screen for HIV, active tuberculosis and hepatitis B and C
  • Screen for latent infections, in particular tuberculosis and hepatitis B and C
  • Assess for acute infection
  • Assess varicella zoster antibody status and vaccinate** antibody-negative patients
  • Individual benefit-risk evaluation in patients with prior malignancy
  • Rule out pregnancy in women of childbearing potential. Counsel male and female patients on the potential for
    serious risk to the foetus and need for effective contraception during treatment and for at least 6 months
    after the last dose
*Disease control refers to 75.6% of patients who remained relapse-free without further treatment in Years 3 and 435,36
**Vaccination with live or attenuated live vaccines should be avoided during and after MAVENCLAD® treatment if the patient’s lymphocyte counts are below the lower limit of normal1
DMT=disease-modifying therapy; HIV=human immunodeficiency virus; MRI=magnetic resonance imaging; TB=tuberculosis
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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UK&IE/CLA/0519/0045(1)a - September 2019

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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.