Summary Safety Review - JAKAVI (ruxolitinib) - Assessing the potential risk of drug interactions with P-glycoprotein (P-gp) substrates (including rosuvastatin)
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.
Potential Safety Issue
Drug interactions with P-glycoprotein (P-gp) substrates (e.g. rosuvastatin, digoxin and dabigatran)
Use in Canada
- Ruxolitinib is a prescription drug used to treat adult patients with an enlarged spleen (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 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 had received 1 Canadian reporta of increased blood cholesterol due to a potential interaction between ruxolitinib and rosuvastatin. The review of this case could not conclude whether ruxolitinib interacted with rosuvastatin and/or played a role in the increased blood cholesterol observed in the patient. This is because patients with polycythemia vera may develop higher blood cholesterol levels when their disease is being treated.
- The review also looked at 2 articles in the published literature which did not suggest an interaction between ruxolitinib and other drugs that are known to be transported by P-gp (e.g. digoxin, dabigatran and cyclosporine).
- Available evidence at the time of review suggested that an interaction between ruxolitinib and rosuvastatin was unlikely because ruxolitinib did not appear to inhibit P-gp at doses typically used in patient treatment. Neither rosuvastatin nor ruxolitinib appear to directly interact with P-gp transporters.
Conclusions and actions
- Health Canada's review concluded that the available evidence does not suggest an interaction between ruxolinitib and rosuvastatin or other drugs that are transported by P-gp. Therefore, it is unlikely that any observed increase in blood cholesterol was due to a ruxolitinib interaction with rosuvastatin in the Canadian report. The safety information for these products is appropriate at this time.
- 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 information and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
- Canadian reports can be accessed through the Canada Vigilance Online Database.