Having considered the available evidence from the cumulative review provided by the registration certificate holders of Keytruda (Merck Sharp & Dohme B.V.), Opdivo and Yervoy (BristolMyers Squibb Pharma EEIG), Tecentriq (Roche Registration GmbH), Bavencio (Merck Europe B.V.), Imfinzi (AstraZeneca AB) and Libtayo (Regeneron Ireland), the PRAC committee agreed on the following recommendation – given the unfavorable prognosis of reactivation of Mycobacterium tuberculosis, the PRAC committee discussed the need to emphasize in the section “Special warnings and precautions for use” of the instructions for medical use that infectious and etiologically related diseases should be excluded during use in patients with signs and symptoms of immune-mediated pneumonitis. Accordingly, the registration certificate holders of Tecentriq medicinal products must submit variations within 2 months to amend the instructions for medical use with the information described below (new information being added is underlined):
- to the instructions for medical use of medicinal products containing atezolizumab, add information on immune-related pneumonitis to the “Special warnings and precautions for use” section. Cases of pneumonitis, including fatal cases, have been observed in clinical studies with atezolizumab (see the “Adverse reactions” section). Patients should be monitored for signs and symptoms of pneumonitis and other causes not related to immune-mediated pneumonitis should be excluded. In pneumonitis of grade 2, treatment with atezolizumab should be discontinued and prednisolone or its equivalent should be prescribed at a dose of 1-2 mg/kg/day. If the symptoms of pneumonitis improve to ≤ grade 1, the use of corticosteroids should be tapered over ≥ 1 month. Treatment with atezolizumab may be resumed if pneumonitis has improved to ≤ grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg of prednisolone or equivalent per day. Medicinal products containing atezolizumab must be permanently discontinued in pneumonitis of grade 3 or 4.
Linkhttps://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-9-12-march-2020-prac-meeting_en.pdf
List of medicinal products containing atezolizumab that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 31.03.2020) (2.8 MB) (Downloaded: 25.01.2021 08:42:49)
