Ingenol mebutate gel (Picato▼): increased incidence of skin tumours seen in some clinical studies

Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur.

Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infection such as cytomegalovirus (CMV).

Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions

For most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however, in some circumstances, the Cockcroft-Gault formula should be used to calculate creatinine clearance (CrCl).

Adrenaline auto-injectors: recent action taken to support safety

Healthcare professionals should be aware of alerts and letters issued about adrenaline auto-injectors in September and October 2019.

Letters and drug alerts sent to healthcare professionals in September 2019

Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod.

Medical Device Alerts issued in September 2019

Alerts were issued about T34 ambulatory syringe pumps, Gripper needles, and 1-day Acuvue Moist for astigmatism contact lenses.

Posted on the UK MHRA website on 18 October 2019