Advice for healthcare professionals:
- be aware of reports of serious and fatal cases of thromboembolic events in patients receiving Onivyde for metastatic adenocarcinoma of the pancreas
- a thorough medical history should be obtained in order to identify patients with multiple risk factors in addition to the underlying neoplasm
- advise patients to seek medical advice immediately if signs or symptoms of thromboembolism occur (for example, sudden pain and swelling in a leg or an arm, sudden onset of coughing, chest pain or difficulty breathing)
- report suspected adverse drug reactions (ADRs) to the Yellow Card Scheme – even if the risk is already known, reporting adds to information about the frequency or seriousness of ADRs
Reports of serious thromboembolic events
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) in the EU.
We have no Yellow Card reports of this reaction with this formulation in the UK and usage in the UK is very low, however all prescribers should be aware of this risk when using Onivyde.
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.
All patients should be informed of the signs and symptoms of thromboembolism and be advised to seek medical advice should they occur. Warnings on the signs and symptoms of thromboembolism have also been added to the Patient Information Leaflet.
About Onivyde (irinotecan, liposomal formulations)
Onivyde is indicated for the treatment of metastatic adenocarcinoma of the 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.
Report any suspected adverse drug reactions
Please continue to report any suspected adverse drug reactions to Onivyde via the Yellow Card Scheme. Your report will help us safeguard public health.
Article citation: Drug Safety Update volume 12, issue 8: March 2019: 2.