Onivyde (irinotecan, liposomal formulations) indicated for treatment of metastatic adenocarcinoma of pancreas, in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine-based therapy. Onivyde must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.
A routine EU review assessed cases of serious thromboembolic events reported in patients receiving Onivyde. In the cumulative review (October 2015-April 2018), 23 serious reports of thromboembolic events were identified, of which 4 were fatal. 20 cases of serious thromboembolic events were reported in a 6-month reporting period (October 2017-April 2018).
The reported events included pulmonary embolism, vena cava thrombosis, deep vein thrombosis, catheter site thrombosis, and subclavian vein thrombosis. There were also individual reports of superior vena cava syndrome, portal vein thrombosis, thrombosis, cerebrovascular accident, jugular vein thrombosis, and mesenteric artery thrombosis.
The risk of thromboembolic events has been included in the product information for Onivyde since the time of licensing. However, due to the increased reporting frequency and the seriousness of the reported events, warnings have been added to the Summary of Product Characteristics on the need for a thorough medical history to identify patients with multiple risk factors.
Advise patients to seek medical advice immediately if signs or symptoms of thromboembolism occur. Warnings on the signs and symptoms of thromboembolism have also been added to the Patient Information Leaflet.
Healthcare professionals are advised to report suspected adverse drug reactions to Onivyde via the Yellow Card Scheme.