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Iclusig▼ (ponatinib) - patient safety update

Iclusig▼, for Chronic myeloid leukaemia and Acute lymphoblastic leukaemia from Incyte Biosciences

Incyte Biosciences, the manufacturer of cancer treatment ponatinib, brand name Iclusig▼, have added new potential side effects of aneurysms and artery dissections with an unknown frequency.

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches.

As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon.

Aneurysms can develop in any blood vessel in the body, but the 2 most common places are:
  • the artery that transports blood away from the heart to the rest of the body (the abdominal aorta)
  • the brain
Symptoms of a brain aneurysm include:
  • a sudden agonising headache – it's been described as a "thunderclap headache", similar to a sudden hit on the head, resulting in a blinding pain unlike anything experienced before
  • a stiff neck
  • sickness and vomiting
  • pain on looking at light
Symptoms of abdominal aneurysm include:
  • a pulsing sensation in the tummy (like a heartbeat)
  • tummy pain that doesn't go away
  • lower back pain that doesn't go away
Patients taking Iclusig and experiencing any of these symptoms should consult their doctor immediately.

You can follow developments with Iclusig by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Iclusig (source EMA)
Iclusig is a cancer medicine that contains the active substance ponatinib. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
  • chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
  • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive’ (Ph+). Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome that leads to the development of leukaemia. The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
  • Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate. It is also used in patients who have a genetic mutation called ‘T315I mutation’ which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
These diseases are rare, and Iclusig was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 2 February 2010.

The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors’. These compounds act by blocking enzymes known as tyrosine kinases. Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl. This enzyme is found on the surface of leukaemia cells where it is involved in stimulating the cells to divide uncontrollably. By blocking Bcr‑Abl, Iclusig helps to control the growth and spread of leukaemia cells.

Iclusig was first made available in the EU in 2013. It is manufactured by Incyte Biosciences.

European Medicines Agency website page for Iclusig
NHS website for aneurysms
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 15/08/19
Links available in External Resources

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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