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OCREVUS®  300 mg solution for infusion (ocrelizumab)

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Prescribing Information
Patient Leaflet
Product Information
  • Ocrevus is the only aCD20 approved for the treatment of both RMS and PPMS with more than 10 years of clinical experience and over 300,000 patients treated globally (Ref 1,2) 
  • Early use of Ocrevus preserves function that could otherwise be permanently lost (Ref 3)

     
  • After 10 years:

    • Almost 8 out of 10 PwRMS treated with continuous Ocrevus were progression-free and 92% did not require a walking aid (Ref 3) 

    • > 1/3 of PwPPMS treated with continuous Ocrevus were progression-free and 8 out of 10 did not require a wheelchair (Ref 3)

Preserving patient function, by optimally slowing disease progression, is important to people with MS and is a key treatment goal. The 10 year long-term impact of ocrelizumab on disability in patients with RMS and PPMS from the OLEs of the OPERA I/II and ORARTORIO trials respectively demonstrates that earlier treatment with ocrelizumab resulted in greater reductions in disability progression, with a consistent long-term safety profile in pwRMS and pwPPMS. (Ref 3)

In the controlled period of the pivotal clinical trials, the most important and frequently reported adverse reactions were IRRs and infections (Ref 3)

Patients should be monitored during IV infusion and for at least 1 hour after completion of IV infusion for any symptom of IRR. (Ref 4)

 

Refer to the OCREVUS SmPC for full information regarding adverse events.

 

RMS: relapsing-remitting MS, PPMS: Primary progressive multiple sclerosis, IRR: Infusion related reaction

Further Information


For full prescribing information please refer to the SmPC, available on www.medicines.ie  

 

Medical Information/queries:

MedInfo, ireland.druginfo@roche.com

Product materials:

catherine.dunne@roche.com

Please report adverse events to:

The Drug Surveillance Centre

Roche Products (Ireland) limited

3004, Lake Drive, Citywest, Naas Road, Dublin 24

Tel: +353 (0)1 469 0700

Email: ireland.drug_surveillance_centre@roche.com

Or

HPRA Pharmacovigilance

Website: hpra.ie

 

Marketing Authorisation Holder: Roche Registration GmbH, Emil-Barell- Strasse 1, 79639 Grenzach-Wyhlen, Germany. Ocrevus® is a registered trade mark

References: Ref 1. Hauser SL et al. Engl J Med 2017;367(3);221-234 Ref 2. Newsome SD, Krzystanek E, Selmaj K, Goldstick L, Bermel R, et al. Ocrelizumab Administered Subcutaneously: Results From the Clinical Development Program. Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2024 Ref 3. The Patient Impact of 10 Years of Ocrelizumab Treatment in Multiple Sclerosis: Long-Term Data From the Phase III OPERA and ORATORIO Studies, Hauser SL et al 23 (S31.005) Ref 4. OCREVUS 300 mg concentrate for solution for infusion SmPC https://www.medicines.ie/medicines/ocrevus-300-mg-concentrate-for-solution-for-infusion-33182/spc

 

Further Information


Medical Information/queries:

MedInfo, ireland.druginfo@roche.com

 

 

elaine.quinn.eq1@roche.com
mary.barry@roche.com
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