Update of safety information on pirfenidone-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 27-30 November 2023

In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.

Having considered the known association between the use of pirfenidone and severe cutaneous reactions and the available new evidence on drug-induced eosinophilia with systemic symptoms (DRESS syndrome), including the cumulative review provided by the registration certificate holder (RCH) of the medicinal product Esbriet (Roche Registration GmbH), the PRAC concluded that the RCHs of the medicinal products Esbriet, Pirfenidone axunio, and Pirfenidone Viatris (Roche Registration GmbH, Axunio Pharma GmbH, Viatris Limited) should amend the instructions for medical use as described below (new text underlined, deleted text struck through):

“Special precautions for use” section

Severe cutaneous reactions

Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which can be life-threatening or fatal, have been reported in the post-authorization period with the use of <product name>. If signs and symptoms suggestive of these reactions appear, use of <medicinal product name> should be discontinued immediately. If the patient has developed SJS, or TEN or DRESS syndrome while using <medicinal product name>, use of <medicinal product name> must not be resumed and should be permanently discontinued.

“Adverse reactions” section

Skin and subcutaneous tissue disorders

Stevens-Johnson syndrome¹; toxic epidermal necrolysis¹; drug-induced eosinophilia with systemic symptoms (DRESS syndrome)¹ with the frequency “not known”.

Note: ¹ Identified during post-registration monitoring (see section “Special warnings and precautions for use”).

List of medicinal products containing pirfenidone (pirfenidone) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 28.12.2023)

To analyze the published information, the applicant must use the original text available at the link: