NESP® (darbepoetin alfa) Injection Plastic Syringe – Update of package insert to include risk of severe cutaneous adverse reactions

Kyowa Hakko Kirin (Singapore) Pte Ltd would like to inform healthcare professionals that overseas cases of severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with recombinant human erythropoietins (r-HuEPOs). These reactions are rare and more severe reactions have been observed with long-acting r-HuEPOs (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta).  Some of these cases were life-threatening or fatal. The Singapore package insert for NESP^® has been updated to include the risk of SCAR, including SJS and TEN. Healthcare professionals are advised to educate patients on early signs and symptoms of SJS and TEN. Patients who develop these signs and symptoms should be instructed to discontinue NESP^® and contact their doctor immediately. Switching to other r-HuEPOs is not recommended due to the association of SCAR as a rare class effect for all r-HuEPOs. Please refer to the letter for details.