Revised SPC: Dupixent (dupilumab) solution for injection- all products

SPC now warns that conjunctivitis and keratitis related events have been reported with dupilumab, predominantly in atopic dermatitis patients. Cases of anaphylactic reaction, angioedema, and serum sickness/serum sickness-like reaction have also been reported.

SPS commentary:

SPC also now states that patients with known helminth infections were excluded from participation in clinical studies. Dupilumab may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling. Patients with pre-existing helminth infections should be treated before initiating dupilumab. If patients become infected while receiving treatment with dupilumab and do not respond to anti-helminth treatment, treatment with dupilumab should be discontinued until infection resolves.

Source:

electronic Medicines compendium