Patients must be made aware of the possibility of a hypersensitivity reaction to abacavir that may result in a life-threatening reaction or death and that the risk of a hypersensitivity reaction is increased if they are HLA-B*5701 positive.
The below guidelines can be used by the healthcare professional to conduct the conversation with the patient (or parents and guardians of children).
Patients should contact their physician immediately for advice on whether they should stop taking abacavir if:
- They develop a skin rash; OR
- They develop one or more symptoms from at least two of the following groups:
- Shortness of breath, sore throat or cough
- Nausea or vomiting or diarrhoea or abdominal pain
- Extreme tiredness or achiness or generally ill feeling.
Have a plan to communicate in the event of a reaction
Each patient should be reminded to read the Package Leaflet included in the abacavir pack. They should be reminded of the importance of removing the Warning Card included in the pack, and keeping it with them at all times.
In order to avoid restarting abacavir, patients who have experienced a hypersensitivity reaction should be asked to return the remaining abacavir tablets or oral solution to the pharmacy.
Have your patients read the Warning Card?
Access the Abacavir HSR Warning Card for your location.
NP-GBL-HVX-WCNT-220048 November 2022
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.
If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.