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eNewsletter
August 2019

Welcome

Welcome to the August BNF eNewsletter.

• New editions of BNF & BNF for Children are now available
• Four new drug monographs have been added to the BNF in the last month: dacomitinib, empagliflozin with linagliptin, fremanezumab and vernakalant. One new drug monograph has been added to the BNFC in the last month: fingolimod.
• We have included dose changes for Epipen® preparations (adrenaline/epinephrine) to both the BNF and BNFC.
• We have also included MHRA advice on direct-acting oral anticoagulants, GLP-1 receptor agonists, oral retinoid medicines and Olaratumab (Lartruvo®).

Kind regards,
BNF Team

Other topics:

Significant changes   |   Drug safety update  |   News  |   How to purchase BNF   |   Feedback

Significant changes

BNF BNF only

New monograph: Vizimpro® [dacomitinib] for non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (specialist use only).

New monograph: Glyxambi ® [empagliflozin with linagliptin] for type 2 diabetes mellitus [not controlled by metformin and/or a sulfonylurea with either empagliflozin or linagliptin].

New monograph:Ajovy® [fremanezumab] for prophylaxis of migraine [in patients who have at least 4 migraine days per month] (initiated by a specialist).

New monograph:Brinavess® [vernakalant] for rapid conversion of recent onset atrial fibrillation to sinus rhythm (specialist supervision in hospital).

New preparation: Betesil® [betamethasone] for inflammatory skin disorders [unresponsive to less potent corticosteroids].

New preparation: Blissel® [estriol] for vaginal atrophy in postmenopausal women.

Direct-acting oral anticoagulants (DOACs) (apixaban, dabigatran etexilate, edoxaban, and rivaroxaban): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome [MHRA/CHM advice].

GLP-1 receptor agonists (dulaglutide, exenatide, liraglutide (Victoza®), lixisenatide, and semaglutide): reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued [MHRA/CHM advice].

Oral retinoid medicines (acitretin, alitretinoin, bexarotene, isotretinoin, and tretinoin): revised and simplified pregnancy prevention educational materials for healthcare professionals and women [MHRA/CHM advice].

Olaratumab (Lartruvo®): withdrawal of the EU marketing authorisation due to lack of efficacy [MHRA/CHM advice].

Atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer [NICE guidance].

Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes [NICE guidance].

Ocrelizumab for treating primary progressive multiple sclerosis [NICE guidance].

Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib [NICE guidance].

Lenalidomide plus dexamethasone for previously untreated multiple myeloma [NICE guidance].

Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality [NICE guidance].

Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies [NICE guidance].

Urinary incontinence and pelvic organ prolapse in women: updated guidance on management.

Dose Changes for BNF only
Epipen® preparations (adrenaline/epinephrine) [body-weight ranges for children's dosing updated].

BNF for Children BNFC Only

New monograph: Gilenya® [fingolimod] for multiple sclerosis (initiated by a specialist).

Flutiform® 50 microgram/ 5 microgram inhaler (fluticasone with formoterol): age range extension to include children aged 5 to 12 years for the prophylaxis of asthma.

Oral retinoid medicines (acitretin, isotretinoin, and tretinoin): revised and simplified pregnancy prevention educational materials for healthcare professionals and women [MHRA/CHM advice].

Dose Changes for BNFC only
Epipen® preparations (adrenaline/epinephrine) [body-weight ranges for children's dosing updated]

BNF BNF for Children Both BNF and BNFC

Crohn's disease: updated guidance on management.

Contraceptives, hormonal: updated guidance on combined hormonal contraceptives.

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.

Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease

Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation

Rivaroxaban (Xarelto): reminder that 15 mg and 20 mg tablets should be taken with food

News

The new BNF and BNF for Children - now available!
Next month we celebrate 70 years of unrivalled guidance on prescribing and administering medicines to adults and children. Since 1949 the British National Formulary (BNF) has been the UK's most trusted & authoritative healthcare resource, helping to ensure the safe and effective use of medicines at the point of care.

Significant new content updates for the BNF 78 include:

Updated guidance on attention deficit hyperactivity disorder, breast cancer, chronic heart failure, epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), renal and ureteric stones, smoking cessation, and antibacterial therapy for respiratory system infections in acute exacerbations of bronchiectasis, COPD and acute cough.

New preparations including Buvidal® (buprenorphine), Delstrigo® (lamivudine with tenofovir disoproxil and doravirine), Diacomit® (stiripentol), Namuscla® (mexiletine), Ozempic® (semaglutide), Steglatro® (ertugliflozin), Suliqua® (insulin glargine with lixisenatide), Symkevi® (tezacaftor with ivacaftor)

BNF 78
New safety information about the risk of acute pancreatitis with carbimazole, use of elvitegravir with cobicistat in pregnancy, new restrictions and precautions for fluoroquinolone antibiotics, and valproate medicines and serious harms in pregnancy.

Updated recommendations on heavy menstrual bleeding, methotrexate (conception and contraception), malaria prophylaxis, typhoid vaccine and yellow fever vaccine in line with Public Health England recommendations.

Order your copy of the BNF 78

BNF for Children 2019-2020 content updates include:

Updated guidance on diabetic complications, dyslipidaemias, heavy menstrual bleeding, Lyme disease, management of otitis media, oropharyngeal infections, smoking cessation, and prophylaxis of venous thromboembolism.

New safety information about the risk of severe and fatal burns with paraffin-containing and paraffin-free emollients, and the risk of airway obstruction from aspiration of loose objects when using pressurised metered dose inhalers.

BNFC 2019-2020
Significant dose changes including amoxicillin, azithromycin, ceftriaxone, doxycycline and erythromycin for Lyme disease, dosing schedule of Japanese encephalitis vaccine, Malarone® Paediatric for prophylaxis of falciparum malaria, and mometasone furoate for prophylaxis and treatment of seasonal allergic or perennial rhinitis.

New preparations including Cetraxal Plus® (ciprofloxacin with fluocinolone acetonide), Ivemend® (fosaprepitant), Palexia® oral solution (tapentadol), Slenyto® (melatonin), Symkevi® (tezacaftor with ivacaftor), Tygacil® (tigecycline), Verkazia® eye drops (ciclosporin), Zebinix® (eslicarbazepine acetate), Zemplar® (paricalcitol).

Guidance on prescribing: New Medicines Service and Medicines Use Review service information included, and highlighted in the relevant treatment summaries.

Order your copy of the BNFC 2019-2020

"Never Events"
NHS Improvement defines a Never Event as 'Serious Incidents that are wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare professionals'. The online BNF publications have recently added information about never events in the "Guidance on prescribing" section. The following monographs have also been updated to contain never events related content in the important safety information section:

- All insulins
- Potassium chloride
- Methotrexate
- Midazolam

Further information on never events can be found under "Guidance on prescribing" on BNF online and the NHS Never Events policy and framework can be viewed here.

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 commonwealthpharmacy.org/what-we-do/pharmaid/. If you would like to donate your copy email: admin@commonwealthpharmacy.org.

How to purchase BNF

Print
Print
To order the September 2019 edition, visit the Pharmaceutical Press website

Subscription
Subscription
Purchase a print subscription, ensure access to the latest copy of BNF and save money

online
Online
Outside the UK, content is available via a subscription to MedicinesComplete

eBook
eBook
Access the latest copy of BNF on your mobile device, which is available as a PDF eBook

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