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January 2020

Welcome to the January BNF Newsletter.

• Three new drug monographs have been added to the BNF in the last month: gilteritinib, meropenem with vaborbactam, and neratinib.
• MHRA advice on ambrisentan (Volibris®), carfilzomib (Kyprolis®), and yellow fever vaccine, live.

Kind regards,
BNF Team

Other topics:

Significant changes   |   Drug Safety Update

Significant changes

BNF BNF only

New monograph: Nerlynx® [neratinib] for HER2-overexpressed/amplified breast cancer (specialist use only).

New monograph: Vaborem® [meropenem with vaborbactam] for complicated urinary-tract infection [including pyelonephritis], complicated intra-abdominal infection, hospital-acquired pneumonia, ventilator-associated pneumonia, bacteraemia [occurring in association with or suspected to be associated with the licensed indications], and aerobic Gram-negative infections [in patients with limited treatment options] (administered on expert advice).

New monograph: Xospata® [gilteritinib] for FLT3 mutation-positive acute myeloid leukaemia (specialist use only).

New preparations: Pepto-Bismol® [bismuth subsalicylate] for Helicobacter pylori eradication [in combination with other drugs (see Helicobacter pylori infection)].

New preparations: Softacort® [hydrocortisone eye drops] for local treatment of conjunctival inflammation (short-term).

Ambrisentan (Volibris®): patient alert card available [MHRA/CHM advice].

Carfilzomib (Kyprolis®): risk of reactivation of hepatitis B virus [MHRA/CHM advice].

Chronic obstructive pulmonary disease: updated guidance on management.

Dyspepsia, Gastro-oesophageal reflux disease, and Peptic ulcer disease: updated guidance and dosing regimens.

Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema in phakic eyes after an inadequate response to previous therapy [NICE guidance].

Helicobacter pylori infection: updated guidance and dosing regimens.

Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab [NICE guidance].

Pentosan polysulfate sodium for treating bladder pain syndrome [NICE guidance].

Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer [NICE guidance].

BNF BNF for Children Both BNF and BNF for Children

Asthma, acute: updated guidance on management.

Asthma, chronic: updated guidance on management.

Yellow fever vaccine, live: stronger precautions in people with weakened immunity and in those aged 60 years or older [MHRA/CHM advice].

BNF for Children BNF for Children Only

Gastro-oesophageal reflux disease: updated guidance.

Drug Safety Update

Drug Safety Update is a monthly newsletter from the MHRA and Commission on Human Medicine. Please follow this link to review the latest Drug Safety Update.

Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents.



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