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November 2019

Welcome to the November BNF Newsletter.

• Two new drug monographs have been added to both BNF and BNF for Children in the last month: dupilumab and larotrectinib. Three new drug monographs have been added to the BNF in the last month: lorlatinib, talazoparib and volanesorsen.
• A dose change for human papillomavirus vaccines has been made to both the BNF and BNFC. There has also been a dose change for magnesium sulfate in the BNF.
• MHRA advice on fingolimod (Gilenya®), hormone replacement therapy (HRT) (conjugated oestrogens (equine) and estradiol), mitomycin (Mitomycin-C Kyowa® 40 mg), montelukast (Singulair®), parenteral nutrition products and pentosan polysulfate sodium (Elmiron®).

Kind regards,
BNF Team

Other topics:

Significant changes   |   BNF Case Study   |   Clostridium difficile update   |   Drug Safety Update

Significant changes

BNF BNF only

New monograph: Waylivra® [volanesorsen] for familial chylomicronaemia syndrome (specialist use only)

New monograph: Lorviqua® [lorlatinib] for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (specialist use only)

New monograph: Talzenna® [talazoparib] for breast cancer (initiated by a specialist)

Benralizumab for treating severe eosinophilic asthma (updated advice) [NICE guidance].

Hormone replacement therapy (HRT) (conjugated oestrogens (equine) and estradiol): further information on the known increased risk of breast cancer with HRT and its persistence after stopping [MHRA/CHM advice].

Hypertension: updated guidance on management of hypertension in pregnancy.

Sodium zirconium cyclosilicate for treating hyperkalaemia [NICE guidance].

Mitomycin (Mitomycin-C Kyowa® 40 mg): restricted to intravesical administration only for treatment of superficial bladder cancer [MHRA/CHM advice].

Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer [NICE guidance].

Pentosan polysulfate sodium (Elmiron®): rare risk of pigmentary maculopathy [MHRA/CHM advice].

Dose Changes for BNF only
Magnesium sulfate: Change to additional dose for seizure recurrence in pre-eclampsia and eclampsia.

BNF for Children BNF for Children Only

New preparation: Orkambi® granules [lumacaftor with ivacaftor] for cystic fibrosis (specialist use only)

Parenteral nutrition supplements: light protection required to reduce the risk of serious adverse effects in premature neonates [MHRA/CHM advice].

BNF BNF for Children Both BNF and BNF for Children

New monograph: Dupixent® [ dupilumab] for moderate-to-severe atopic eczema (initiated by a specialist), severe asthma with type 2 inflammation [add-on maintenance therapy] (initiated by a specialist), and severe asthma with type 2 inflammation [add-on maintenance therapy for patients currently treated with oral corticosteroids or patients with co-morbid moderate-to-severe atopic dermatitis] (initiated by a specialist)

New monograph: Vitrakvi® [ larotrectinib] for solid tumours with neurotrophic tyrosine receptor kinase gene fusion (initiated by a specialist)

New preparation: Gardasil 9® [ human papillomavirus vaccines] for immunisation against HPV-related premalignant lesions and cancer (cervical, vulvar, vaginal, and anal) and genital warts [2 dose schedule], and immunisation against HPV-related premalignant lesions and cancer (cervical, vulvar, vaginal, and anal) and genital warts [3 dose schedule]

New preparation: Nyxoid® [ naloxone hydrochloride] for overdosage with opioids, and overdosage with opioids in a non-medical setting

Fingolimod (Gilenya®): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception [MHRA/CHM advice].

Human papillomavirus vaccine updated guidance in-line with Public Health England recommendations.

Immunisation schedule: updated national human papillomavirus immunisation programme in-line with Public Health England recommendations.

Montelukast (Singulair®): reminder of the risk of neuropsychiatric reactions [MHRA/CHM advice].

Dose Changes for BNF and BNF for Children
Human papillomavirus vaccines: Dosing now includes male patients.

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.

Ingenol mebutate gel (Picato): increased incidence of skin tumours seen in some clinical studies.

Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation.

Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions.

Adrenaline auto-injectors: recent action taken to support safety.




BNF 78 Case Study - Volume 4

Volume 4 of our digital case studies focused on the management of chronic heart failure and smoking cessation, based on the content from the BNF78, is now available for download.

If you're an online BNF user, access the additional content on MedicinesComplete by clicking the interactive links in the case study, which link through to the relevant content pages.

Download your copy

Clostridium difficile renamed as Clostridioides difficile
In 2016, the genus of species Clostridium was transferred to Clostridioides to reflect the changes in microbial taxonomy. As a result, the organism Clostridium difficile has officially been renamed as Clostridioides difficile but the clinical abbreviations C. diff and C. difficile will remain in use.

The BNF team are currently in the process of updating the terminology throughout the BNF publications to reflect this change. For further information on Clostridioides difficile infection please visit:

Please donate old copies of the BNF
The PharmAid Scheme is an initiative of the Commonwealth Pharmacists Association where recent versions of medicines information resources including the BNF are redistributed to low and middle income countries. You can make a difference in another commonwealth country by simply donating your old BNF copies to them.

For more information on this scheme see If you would like to donate your copy email:


How to purchase BNF






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