Important risk minimisation information for healthcare professionals prescribing Baricitinib Lilly (baricitinib)

Patient Alert Card containing important safety information for patients.

Risk minimisation for healthcare professionals prescribing Baricitinib Lilly

The updates are as follows;

• Addition of the immune-mediated adverse reactions sclerosing cholangitis, arthritis, polymyalgia rheumatica, and Sjogren’s syndrome based on post-marketing data and literature
• Deletion of the word “ Alert” from the document name, Patient Alert Card

This change is triggered by the approval of the Type II variation in UK PLGB 11648/0262 – 0037 and introduction of the new version of the RMP v 7.3 for Bavencio 20 mg/ml concentrate for solution for infusion.

Important Safety Information for Patients Receiving BEKEMV and showing this card to any doctor involved in your care.

This guide is for adult patients and parents/legal guardians of a child (above 2 years) who has been prescribed eculizumab. The guide provides you with important safety information that you must be aware of.

The aim of this brochure is to educate and/or remind healthcare professionals about the selected prevention measures, detection, careful monitoring and/or proper management of selected safety concerns associated with eculizumab.

Drug distribution will only be possible after written confirmation that the patient received or will receive meningococcal vaccination and/or antibiotic prophylaxis from the healthcare providers

HCP guide to minimise the risk of application errors due to confusion of different types of IUS and to reduce the risk of ectopic pregnancies.

Update to the Patient Card.

Beovu (Brolucizumab) - Patient Guide to Therapy - for patients with visual impairment due to DMO

Beovu (Brolucizumab) - Patient Guide to Therapy - for patients with visual impairment due to wet AMD

Cover letter when additional risk minimisation materials are distributed to HCPs

Form to be used by eye care professional. The reported results will be sent to HCP to help make decision on belantamab mafodotin treatment.

This material has been tested with consultant ophthalmologist who has previously treated Blenrep patients.

Education booklet for eye care professionals to help them understand and identify the eye-related side effects associated with belantamab mafodotin, so that AEs can be promptly identified and managed according to the SmPC

Education booklet for prescribers to help them understand and identify the eye-related side effects associated with belantamab mafodotin, so that AEs can be promptly identified and managed according to the SmPC

A patient card to record care team contact information and eye drop instructions. It can be provided to community pharmacists to assist in selecting the right eye drops.

Education booklet for patients that provides an overview of eye-related side effects and how they will be monitored and managed according to SmPC.

Bosentan Patient Alert Card

PFIZER CHC Norethisterone or Levonorgestrel VTE and ATE RMM Checklist for prescribers

PFIZER CHC Norethisterone or Levonorgestrel VTE and ATE RMM Patient card

PFIZER CHC Norethisterone or Levonorgestrel VTE and ATE RMM Patient sheet

This educational guide forms part of the additional risk minimisation measures for lisocabtagene maraleucel. It contains information regarding selected lisocabtagene maraleucel-associated adverse reactions of cytokine release syndrome (CRS), neurologic toxicities, including immune effector cell associated neurotoxicity syndrome (ICANS), and secondary malignancy of T-cell origin. These are not all the adverse reactions associated with lisocabtagene maraleucel. Please refer to the lisocabtagene maraleucel SmPC for more information.

The Patient Card is an important document that should be carried by the patient at all times. It contains key information, including symptoms that the patient should be aware of and look out for.

This guide forms part of the additional risk minimisation measures for lisocabtagene maraleucel. It is intended for healthcare professionals involved in the transport, storage, thawing, preparation, handling, and/or administration of lisocabtagene maraleucel. It provides guidance on the correct procedures for proper handling, thawing, preparation and administration to minimise the potential risk of reduced viability of lisocabtagene maraleucel due to inappropriate product handling.

Bronchitol Healthcare Professional Leaflet