Human medicines European public assessment report (EPAR): Spectrila, asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 14/01/2016, Revision: 6, Status: Authorised
The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests. For the full list of side effects reported with Spectrila, see the package leaflet.
The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.
Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems. It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment. For the full list of restrictions, see the package leaflet.
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