Letters sent to healthcare professionals in June 2018

Letters were sent about Cetrotide (cetrorelix acetate), Eperzan▼(albiglutide), darunavir/cobicistat, Keytruda▼ (pembrolizumab), Denzapine (clozapine) 50 mg/mL oral suspension, and Bleo-Kyowa (bleomycin sulphate).

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 July 2018

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Haematology and Immunosuppression and transplantation
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  Infectious disease, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Psychiatry, and Urology and nephrology

• Cetrotide (cetrorelix acetate): Risk of missed doses or loss of sterility when using new syringe with different design

• Eperzan▼(albiglutide): reminder letter regarding the discontinuation

• Darunavir/cobicistat: Increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection when darunavir and cobicistat coadministered, due to low exposure values during the second and third trimesters of pregnancy

• Keytruda▼ (pembrolizumab): Restriction of indication for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy

• Denzapine 50 mg/mL Oral Suspension (clozapine): risk of loss of efficacy due to crystallisation of the suspension; always follow instructions for use, including 24 hours before first dosing , see company-led recall

• Bleo-Kyowa (bleomycin sulphate), powder for solution for injection: use 5 micron filter during IV infusion or pre-injection, see class 4 medicines defect information

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Article citation: Drug Safety Update volume 11, issue 12; July 2018: 6.

Published 17 July 2018