Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

medicinal products containing dabrafenib, trametinib – sarcoidosis

Having considered the available evidence and analyzed the data provided by the relevant marketing authorization holder, the PRAC committee agreed that the package leaflet for medicinal products containing dabrafenib and trametinib should be updated to reflect the risk of sarcoidosis when these products are used in combination.

If more evidence emerges in the future, marketing authorization holders should consider the need for further updating of the patient information leaflet regarding sarcoidosis when these medicines are used as monotherapy.

Marketing authorization holders of the medicinal products Tafinlar and Mekinist (Novartis Europharm Limited) must submit variations within 2 months of publication of the PRAC recommendation in order to amend the package leaflet as indicated below (new text underlined):

Tafinlar (dabrafenib)

• into the "Special warnings and precautions for use" section of the instructions

Sarcoidosis

Cases of sarcoidosis have been reported in patients receiving dabrafenib in combination with trametinib, mainly involving the skin, lungs, eyes, and lymph nodes. In most cases, treatment with dabrafenib and trametinib was continued. If sarcoidosis is diagnosed, appropriate treatment should be considered. It is important not to interpret sarcoidosis as disease progression.

• in the “Adverse reactions” section of the instructions, in the tabular list of adverse reactions – table 4, under immune system impairment with “uncommon” frequency: sarcoidosis.

Mekinist (trametinib)

• into the "Special warnings and precautions for use" section of the instructions

Sarcoidosis

Cases of sarcoidosis have been reported in patients receiving trametinib in combination with dabrafenib, mainly involving the skin, lungs, eyes, and lymph nodes. In most cases, treatment with trametinib and dabrafenib was continued. If sarcoidosis is diagnosed, appropriate treatment should be considered. It is important not to interpret sarcoidosis as disease progression.

• in the “Adverse reactions” section of the instructions, in the tabular list of adverse reactions – table 5, under immune system disorders with “uncommon” frequency: sarcoidosis.

Link

https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-26-29-october-2020-prac-meeting_en.pdf