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.
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing lomustine, reached the following conclusions.
In view of the available data on overdose from the literature and spontaneous reports, the PRAC considers that a causal relationship between the use of lomustine and overdose is at least possible. The PRAC concluded that the instructions for medical use of medicinal products containing lomustine should be amended accordingly.
In view of the data available in the literature on thrombocytopenia and considering the likely mechanism of action, PRAC considers that a causal relationship between the use of lomustine and thrombocytopenia is at least possible. PRAC concluded that the instructions for medical use of medicinal products containing lomustine (lomustine) should be amended accordingly.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by PRAC.
Based on the scientific conclusions on lomustine, the CMDh considers that the benefit/risk balance of medicinal products containing lomustine remains unchanged, provided that the proposed changes are made to the instructions for medical use.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
“Special precautions for use” section
[…]
Patients must be clearly informed that they must not take higher doses of <medicinal product> than recommended by the doctor, and that the <medicinal product> dose is taken orally once <(or divided over three days)> and will not be repeated for at least 6 weeks (see section “Method of administration and doses”).1
[…]
“Adverse reactions” section
The frequency of the adverse reaction thrombocytopenia should be changed to “very common”.
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1 The existing warning in the section “Special warnings and precautions for use” of the instructions for medical use should be highlighted in bold and underlined or added if it is absent (the new added text should be highlighted in bold and underlined; the option of dose splitting remains as an alternative only for medicinal products for which such dosing is possible in accordance with the existing dosing recommendations in the section “Method of administration and doses” of the instructions for medical use).
List of medicinal products containing lomustine and approved for medical use in Ukraine (according to the State Register of Medicinal Products as of 07.12.2023)
To analyze the published information, the applicant must use the original text available at the link:
