Health Canada is requiring a new warning to be added to the Canadian prescribing information for the skin-cancer drug Zelboraf (vemurafenib) advising of the risk of pancreatitis.
Zelboraf is used in adults to treat a type of skin cancer (melanoma with a mutation in a specific gene) that either cannot be removed by surgery, or has spread to other parts of the body. The drug targets proteins made from a gene called BRAF that has mutated, Health Canada explains. Zelboraf slows down or stops the growth of cancer cells.
Health Canada, the national health regulatory agency, conducted a safety review of Canadian and international case reports and other data. Drug-induced pancreatitis in patients using Zelboraf was reported in Canada and abroad, with the reaction generally occurring in the first two weeks of Zelboraf treatment.
Pancreatitis is an inflammation of the pancreas, with symptoms ranging from mild discomfort to severe, life-threatening illness. Most people with acute (sudden-onset) pancreatitis recover completely with appropriate treatment in a hospital. Health Canada advises patients taking Zelboraf who experience severe pain in the upper abdomen, accompanied by nausea, vomiting, or abdominal tenderness, to stop taking Zelboraf and talk to their health care provider immediately. After an episode of pancreatitis, the patient should be closely monitored if re-starting Zelboraf, and dose modification should be considered.
Canadian prescribing information has been updated to include the pancreatitis risk and Health Canada has published a Summary Safety Review with additional information about the review.