Summary Safety Review - Ruxolitinib - Assessing the potential risk of liver injury
February 26, 2018
Potential Safety Issue
Liver (hepatic) injury
- Ruxolitinib is a prescription drug authorized for sale in Canada to treat adult patients with certain types of blood cancers. Health Canada carried out a safety review after receiving information that included an international report of a suspected serious liver injury from an ongoing study that used ruxolitinib to treat patients.
- Although the risk of liver injury is not mentioned in the safety information for ruxolitinib, it recommends that healthcare professionals test the patient's blood before and during treatment for signs of liver problems.
- 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.Health Canada will continue to monitor the safety of ruxolitinib.
Health Canada carried out a safety review after receiving information that included an international report of a suspected serious liver injury from an ongoing study that used ruxolitinib to treat patients. The manufacturer was asked to provide all available data on this drug and the risk of liver injury. The product information already recommends that healthcare professionals test the patient's blood to check liver function before starting treatment with ruxolitinib and at regular periods afterward to see how patients respond to the treatment, or to see if ruxolitinib is having an unwanted effect and to adjust the dose if necessary. However, the risk of liver injury or liver failure with the use of ruxolitinib is not mentioned.
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 reportFootnote a 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.
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.
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