The US Food and Drug Administration has inserted a new warning on serious cases of rash to the package insert for etravirine (Intelence), a non-nucleoside reverse transcriptase inhibitor recently approved for treatment-experienced patients in the United States and Europe.
Patients and doctors are warned that severe cases of rash have occurred in around 1.3% of patients in phase 3 studies of the drug, and that 2% of patients had to stop taking the drug due to serious rash, usually in the first six weeks of treatment.
In the most serious cases patients taking etravirine developed Stevens-Johnson syndrome or other severe skin reactions in which regions of the skin blister and peel away.
Patients are warned to be alert for the following symptoms accompanying any rash when starting etravirine: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling and/or signs and symptoms of liver problems (e.g., yellowing of your skin or whites of your eyes, dark or tea coloured urine, pale coloured stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs).
If these symptoms occur treatment with the drug should cease and patients should contact their HIV physician immediately for close monitoring and an alternative antiretroviral prescription. Any patient developing a rash while taking etravirine should contact their health care provider, the FDA advises.
A similar warning is expected to be added to European package inserts by the European Medicines Agency within the next few weeks.