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Newsletter
September 2020

Welcome to the September BNF Newsletter

• Two new drug monographs have been added to both the BNF and BNF for Children in the last month: cefazolin and remdesivir. Two new drug monographs have been added to the BNF in the last month: delafloxacin and isatuximab.

• MHRA advice on aflibercept, amphotericin B, andexanet alfa, axitinib, bevacizumab, cabozantinib, capecitabine, cytarabine, daunorubicin, daunorubicin with cytarabine, doxorubicin hydrochloride, flucytosine, fluorouracil, irinotecan hydrochloride, lenvatinib, nintedanib, pazopanib, ponatinib, ramucirumab, regorafenib, sorafenib, sunitinib, tegafur with gimeracil and oteracil, tivozanib and vandetanib.

In this issue

Significant changes   |   Drug Safety Update   |   BNF app   |   BNF80   |   BNFC 2020-2021   |   Community Nurse Practitioners

Significant changes

BNF BNF only

New monograph: Quofenix® [delafloxacin] for acute bacterial skin and skin structure infections.

New monograph: Sarclisa® [isatuximab] for multiple myeloma in patients who have received at least two prior therapies (in combination with pomalidomide and dexamethasone).

Aflibercept: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Andexanet alfa (Ondexxya®): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa [MHRA/CHM advice].

Atezolizumab (Tecentriq®) with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer [NICE guidance].

Atezolizumab (Tecentriq®) with nab-paclitaxel for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer [NICE guidance].

Axitinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Bevacizumab: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

BNF updates for Community Practitioner Nurse Prescribers: For BNF app and online versions of the BNF - list of medicinal preparations (renamed as Approved list for prescribing by Community Practitioner Nurse Prescribers (NPF)) updated with indications for use by Community Practitioner Nurse Prescribers and links to BNF monographs; general guidance and treatment summaries for use by Community Practitioner Nurse Prescribers have also been added. For BNF print editions - list of medicinal preparations (Nurse Prescribers’ Formulary (NPF)) updated with indications for use by Community Practitioner Nurse Prescribers and cross-references to BNF monographs. For further information, see How to use the NPF above the list of medicinal preparations.

Cabozantinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Capecitabine: Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity [MHRA/CHM advice].

Daunorubicin with cytarabine: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice].

Fluorouracil: Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity [MHRA/CHM advice].

Irinotecan hydrochloride: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice].

Lenvatinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Nintedanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Pazopanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Ponatinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Ramucirumab: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Regorafenib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Sorafenib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Sunitinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Tegafur with gimeracil and oteracil: Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity [MHRA/CHM advice].

Tivozanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Vandetanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice].

Dose changes for BNF only
Ofloxacin [update to dosing for complicated skin and soft-tissue infections].

Ofloxacin [update to dosing for complicated urinary-tract infections].

Ofloxacin [update to dosing for lower respiratory-tract infections].

Ofloxacin [update to dosing for urinary-tract infections].

BNF BNF for Children Both BNF and BNF for Children

New monograph: Cefazolin for surgical prophylaxis, skin infection, soft tissue infection, bone infection and joint infection.

New monograph: Veklury® [remdesivir] for COVID-19 in patients with pneumonia requiring supplemental oxygen.

Amphotericin: name change to amphotericin B.

Amphotericin B: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice].

Cytarabine: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice].

Daunorubicin: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice].

Doxorubicin hydrochloride: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice].

Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency [MHRA/CHM advice].

Dose changes for BNF and BNF for Children
Cefixime [update to dosing for uncomplicated gonorrhoea].

 
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.

Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use

Clozapine and other antipsychotics: monitoring blood concentrations for toxicity

Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment

Baricitinib (Olumiant): increased risk of diverticulitis, particularly in patients with risk factors

Isotretinoin (Roaccutane): reminder of important risks and precautions

Emollients and risk of severe and fatal burns: new resources available

 
 

News

Have you updated your BNF app?

Following the launch of the improved BNF and BNF for Children app last month, the latest update is now available for all users.

We would encourage you to download the update as soon as possible, v3.0.1 on the AppStore and v3.0.2 on the Google Play store.

As a reminder, switch on automatic updates to get instant access to the most up-to-date version of the BNF app.

Update your BNF app

BNF App

BNF 80 now available

The British National Formulary (BNF) is the first choice for concise medicines information. Trusted by healthcare professionals across the world to support confident decision-making at the point of care. The new edition (BNF 80) provides up-to-date guidance on prescribing, dispensing, and administering medicines, plus legal and professional guidelines.

978-0-85711-370-2 | August 2020 | 1712pp | £59.95

Extensive content updates in the new edition include new monographs on:

Beovu ® [brolucizumab] for neovascular (wet) age-related macular degeneration
Cytotect ® [cytomegalovirus immunoglobulin] for prophylaxis of cytomegalovirus infection in patients taking immunosuppressants, particularly transplant recipients
Mayzent ® [siponimod] for multiple sclerosis [secondary progressive, with active disease]
   
BNF 80

MHRA advice on:

Etonogestrel (Nexplanon ®) contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration
Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy
Ulipristal acetate (Esmya ®): suspension of the licence due to risk of serious liver injury
   
Order now

BNF for Children 2020-21 now available

The British National Formulary for Children is the first choice for concise medicines information for children. Trusted by healthcare professionals across the world to support confident decision-making at the point of care.

The new edition provides up-to-date guidance on prescribing, dispensing, and administering medicines to children, plus legal and professional guidelines.

978-0-85711-372-6 | August 2020 | 1222pp | £59.95

Extensive content updates in the new edition include:

New monographs on:

BNFC 2020-2021
Gilenya ® [fingolimod] for multiple sclerosis
Mozobil ® [plerixafor] to mobilise haematopoietic stem cells to peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma or solid malignant tumours
Renapime ® [cefepime] for bacterial infection
   

Dose changes:

Epipen ® preparations (adrenaline/epinephrine) [body-weight ranges for children's dosing updated]
Idursulfase [updated age range]
   
Order now

BNF updates for Community Practitioner Nurse Prescribers

Within the BNF app and online versions of the BNF, the NPF list of medicinal preparations has been updated with indications for use by Community Practitioner Nurse Prescribers and links to BNF monographs; this record has also been renamed as Approved list for prescribing by Community Practitioner Nurse Prescribers (it was previously named Nurse Prescribers' Formulary (NPF).

Within the BNF app and online versions of the BNF, the general guidance and treatment summaries for use by Community Practitioner Nurse Prescribers have also been added.

Within the BNF print editions, the NPF list of medicinal preparations has been updated with indications for use by Community Practitioner Nurse Prescribers and cross-references to BNF monographs.

For further information, see How to use the NPF above the list of medicinal preparations.

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.

 
 

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