Table 2.

Example of risk minimization measures

Risk identified	Risk minimization measure	Objective and rationale	Description
Serious infections (including opportunistic infections, tuberculosis, Legionella, Listeria, parasitic infection)	Patient alert card	To provide information to patients to make them aware that, during treatment with Benepali®, there is an increased risk of acquiring serious infections or that existing infections may get worse	Patient alert card will be provided to Benepali® prescribing physicians for distribution to patients receiving Benepali® This card provides important safety information for patients, including information relating to infections
Worsening heart failure (worsening of congestive heart failure in adult patients)	Patient alert card	To provide adequate information to patients to make them aware of the increased risk of worsening of heart failure during treatment with Benepali®	Patient alert card will be provided to prescribing physicians for distribution to patients receiving Benepali® This card provides important safety information for patients, including information relating to heart failure
Potential for medication errors (pre-filled pen)	Educational material for healthcare professionals and patients	To alert patients and healthcare professionals to the risk of medication errors in patients using a pre-filled pen	A mock pre-filled pen device for practice will be provided to healthcare professionals An educational programme will be provided to healthcare professionals and patients
Potential for pediatric off-label use	Educational material/patient alert card	To remind patients and healthcare professionals that Benepali® is not indicated for children under the age of 18 years	Warnings will be inserted in the patient alert card An educational programme will be provided to healthcare professionals and patients

Summary of information from [61]. Example shown is for a biosimilar etanercept (Benepali^®).