Summary Safety Review - Ruxolitinib - Assessing the potential risk of liver injury
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2018-02-26
Product
Ruxolitinib
Potential Safety Issue
Liver (hepatic) injury
Overview
Use in Canada
- Ruxolitinib is a prescription drug used to treat adult patients with an enlarged spleen (i.e. splenomegaly) and to help control the symptoms caused by myelofibrosis, a rare form of blood cancer. It is also used to control the excess amount of red blood cells in the blood in certain patients with polycythemia vera, a type of blood cancer.
- Ruxolitinib has been marketed in Canada since 2012 under the brand name Jakavi and is available as tablets taken by mouth.
Safety Review Findings
- At the time of the review, Health Canada received one Canadian reporta of liver injury (i.e., liver failure) in a patient treated with ruxolitinib. The review of this case showed that the liver failure was likely due to the worsening (i.e., progression) of the disease for which the patient received ruxolitinib and not the drug itself.
- This safety review looked at information collected by the manufacturer. Health Canada reviewed 25 international patient reports of liver injury or liver failure with the use of ruxolitinib. These reports provided information about the patients' symptoms and blood tests that indicated liver injury or liver failure. The symptoms happened during treatment with ruxolitinib or within 30 days of stopping the treatment.
- A possible link between liver problems and the use of ruxolitinib was found in 11 reports and included the report from the study that triggered the review. However, it was not possible to determine whether ruxolitinib itself caused the liver problems because in general, patients with myelofibrosis and polycythemia vera often have liver problems due to their disease and also take other medications that may affect the liver. In 13 of the 25 reports, the liver problems were likely due to other causes such as other drugs or the disease itself. In the remaining report there was not enough information provided to determine whether or not ruxolitinib caused the liver injury.
Conclusions and actions
- Health Canada's review concluded that the evidence does not show a link between ruxolitinib and the risk of liver injury. The safety information for the drug is appropriate at this time because it recommends that healthcare professionals test the patient's blood to check the liver before starting treatment with ruxolitinib and at regular periods afterward.
- Health Canada will continue to monitor safety information involving ruxolitinib, 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 if and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Online Database.