Summary Safety Review - Neulasta (pegfilgrastim) - Assessing the Potential Risks of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Neulasta (pegfilgrastim)

Stevens-Johnson syndrome (SJS), a serious disorder of the skin and mucous membranes, and toxic epidermal necrolysis (TEN), a severe form of Stevens-Johnson syndrome

• Health Canada’s safety review did not find sufficient evidence to support a link between the use of Neulasta and the risks of SJS and TEN.

• Health Canada reviewed the potential risks of SJS and TEN with the use of Neulasta, a prescription drug authorized for the treatment of neutropenia (low white blood cells) that is caused by chemotherapy. The safety review was triggered by cases of SJS and TEN that were reported in 2023 by the manufacturer of Neulasta.

• Health Canada will continue to monitor the safety of Neulasta.

Health Canada has been monitoring the potential risks of SJS and TEN with the use of Neulasta since the EMA’s labelling update for pegfilgrastim-containing products in 2020. At that time, it was determined that Health Canada would continue to monitor the potential risks due to the small number of cases reported. In 2023, following additional cases of SJS or TEN reported by the manufacturer, Health Canada initiated a safety review.

Stevens-Johnson syndrome and TEN are rare severe skin hypersensitivity reactions characterized by painful blisters and lesions on the skin and mucous membranes that could result in hospitalisation and death.

• Neulasta is a prescription drug authorized for sale in Canada for the treatment of neutropenia that is caused by chemotherapy.

• Pegfilgrastim has been marketed in Canada since 2004 under the brand name Neulasta. Biosimilars of pegfilgrastim (Fulphila, Lapelga, Nyvepria and Ziextenzo) are also available and have been marketed since 2019. Neulasta is available as a sterile solution for injection under the skin (subcutaneous).

• Approximately 255,431 prescriptions were filled for Neulasta in Canada between November 2017 and September 2023.

• Health Canada reviewed the available information provided by the manufacturer, and from searches of the Canada Vigilance database^a, international databases and the scientific literature.

• Health Canada reviewed 10 cases (1 Canadian and 9 international) of SJS and/or TEN in patients receiving pegfilgrastim. Of those 10 cases, 5 were found to be possibly linked to the use of pegfilgrastim, 3 were unlikely to be linked and 2 (1 Canadian) could not be assessed due to missing information.

• Health Canada’s review of the 10 cases could not conclude whether pegfilgrastim played a role in the SJS and TEN because all cases reviewed included a combination of other drugs previously known to be associated with the development of SJS and TEN, and were missing information to support a reliable association.

• Health Canada’s review of the scientific literature did not identify any cases of SJS or TEN associated with the use of pegfilgrastim.

• Health Canada’s review of the available information did not find sufficient evidence to support a link between the use of Neulasta and the risks of SJS and TEN. It was determined that the existing product safety information in the Canadian product monograph for Neulasta is appropriate. Therefore, no updates are needed at this time.

• Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of Neulasta, and other health products, to the Canada Vigilance Program.

• Health Canada will continue to monitor safety information involving Neulasta, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of Neulasta both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

1. Canadian reports can be accessed through the Canada Vigilance Online Database.