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Health professionals are advised that the Product Information (PI) for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.
Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody (IgG1 subtype) that is indicated for patients with:
- relapsing forms of multiple sclerosis
- primary progressive multiple sclerosis
Ocrelizumab is marketed in Australia under the brand name Ocrevus and is sponsored by Roche Products Pty Limited.
The Therapeutic Goods Administration (TGA) assessed the risk of late onset neutropenia with ocrelizumab. As of 16 June 2021, four cases of neutropenia associated with ocrelizumab have been reported to the TGA. In three of those cases, ocrelizumab was the sole-suspected drug.
The 'Special Warnings and Precautions for Use' section of the ocrelizumab PI has now been updated with the following information:
Late neutropenia
Cases of late onset of neutropenia have been reported. Although some cases were Grade 3 or 4, the majority of the cases were Grade 1 or 2. Cases of late onset of neutropenia have been reported at least 4 weeks after the latest Ocrevus infusion. In patients with signs and symptoms of infection, measurement of blood neutrophils is recommended (see section 4.8 Adverse Effects (Undesirable Effects)).
Additionally, the 'Adverse Effects (Undesirable Effects)' section has been updated to add the following information under the 'Neutrophils' subheading:
Neutropenia can also occur several months after the administration of Ocrevus, as observed in the post-market setting (see section 4.4 Special Warnings and Precautions for Use, Late neutropenia).
Information for health professionals
Late onset neutropenia is a serious safety concern and requires prompt recognition and treatment. Signs and symptoms of late onset neutropenia may not be apparent initially and can occur at least four weeks after the latest administration of ocrelizumab.
Further reading
- Auer, M., Bsteh, G., Hegen, H. et al. (2020) Late-onset neutropenia in a multiple sclerosis patient after first dose ocrelizumab switched from rituximab. Multiple sclerosis and related disorders, DOI: 10.1016/j.msard.2020.102155.
- Cohen, BA. (2019) Late-onset neutropenia following ocrelizumab therapy for multiple sclerosis. Neurology. DOI: 10.1212/WNL.0000000000006924.
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2021
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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.
Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.
Acting Editor: Dr Catherine Brogan
Deputy Editor: Mr Michael Pittman
Contributor: Ms Rebecca Page and Mr Gilbert Yeap