British National Formulary (BNF)

11th June 2024

British National Formulary

This update contains 10 significant changes, 9 dose changes, 5 new monographs and 3 deleted monographs.

Significant Changes:

• Antibacterials, use for prophylaxis: addition of antibacterial prophylaxis guidance for assisted vaginal birth (ventouse or forceps).
• Borderline substances: products suitable for conditions requiring a ketogenic diet have been moved to a new section called Ketogenic diet.
• Diabetic hyperglycaemic emergencies: updated guidance for management of individuals aged 16-18 years.
• Immunisation schedule: updated guidance for herpes zoster (shingles) immunisation.
• Meningococcal vaccines: updated guidance for immunisation.
• Metformin hydrochloride: new indication and dose for type 1 diabetes mellitus.
• Obstetrics: updated guidance for the prevention and treatment of haemorrhage.
• Prescribing in renal impairment: update to CKD-EPI equation to remove race.
• Sacubitril with valsartan: update to dose expression.
• Varicella-zoster vaccines: updated guidance for immunisation against herpes zoster (shingles).

Dose Changes:

• Bexsero® (meningococcal group B vaccine (rDNA, component, adsorbed)) [update to dosing].
• Carbetocin [update to indication and dose].
• Cyanocobalamin [update to dosing].
• Ergometrine maleate [update to dosing for postpartum haemorrhage caused by uterine atony].
• Ergometrine with oxytocin [update to dosing for active management of the third stage of labour].
• Haemophilus influenzae type b with meningococcal group C vaccine [update to dosing].
• Herpes-zoster vaccine (recombinant, adjuvanted) [update to dosing].
• Meningococcal groups A with C and W135 and Y vaccine [update to dosing].
• Oxytocin [update to dosing for active management of the third stage of labour].

New Monographs:

• Adacel® [diphtheria with tetanus and pertussis vaccine].
• Elrexfio® [elranatamab].
• Omjjara® [momelotinib].
• Opdualag® [nivolumab with relatlimab].
• Velsipity® [etrasimod].

Deleted Monographs:

• Artenimol with piperaquine phosphate.
• Bambuterol hydrochloride.
• Herpes-zoster vaccine (live).

14th May 2024

British National Formulary

This update contains 8 significant changes, 5 dose changes, 5 new monographs, 2 new preparations and 2 deleted monographs.

Significant Changes:

• Budesonide: update to dosing for modified-release capsules.
• Codeine phosphate linctus (codeine oral solutions): reclassification to prescription-only medicine [MHRA/CHM advice].
• Hydrocortisone: updated indication oral and perioral lesions to aphthous ulcers.
• Hyoscine butylbromide: update to important safety information.
• Malaria, prophylaxis: updated guidance.
• Pneumococcal vaccine: updated guidance for immunisation.
• Pseudoephedrine hydrochloride: very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) [MHRA/CHM advice].
• Vaccination, general principles: updated guidance for immunisation of individuals with asplenia, splenic dysfunction, or complement disorders.

Dose Changes:

• Acetylcysteine [update to dosing for paracetamol overdosage].
• Lansoprazole [update to dosing for Zollinger–Ellison syndrome].
• Pantoprazole [update to dosing for Zollinger–Ellison syndrome].
• Paracetamol [update to weight ranges for intravenous paracetamol].
• Pneumococcal polysaccharide conjugate vaccine (adsorbed) [update to dosing].

New Monographs:

• Enspryng® [satralizumab].
• Evkeeza® [evinacumab].
• SimAlvia® [alverine with simeticone].
• Tepkinly® [epcoritamab].
• Zilbrysq® [zilucoplan].

New Preparations: Kinpeygo® [budesonide]; Otinova® [aluminium acetate].

Deleted Monographs: Chloroquine with proguanil; Proguanil hydrochloride.

9th April 2024

British National Formulary

This update contains 6 significant changes, 5 new monographs, 3 new preparations, 1 deleted monograph and 2 deleted preparations.

Significant Changes:

• Ceftriaxone: update to structure of indications and dose section.
• Clindamycin: update to structure of indications and dose section.
• Contraceptives, non-hormonal: updated guidance in-line with Faculty of Sexual & Reproductive Healthcare recommendations on intra-uterine contraception.
• Ezetimibe: new indication for prevention of cardiovascular events.
• Omega-3-acid ethyl esters: (Omacor®/Teromeg® 1000 mg capsules): dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors [MHRA/CHM advice].
• Valproate (Belvo®, Convulex®, Depakote®, Dyzantil®, Epilim®, Epilim Chrono® or Chronosphere®, Episenta®, Epival®, and Syonell®): new safety and educational materials to support regulatory measures in men and women under 55 years of age [MHRA/CHM advice] (advice in sodium valproate, valproic acid; see example in sodium valproate).

New Monographs:

• Cytisinicline.
• Ebglyss® [lebrikizumab].
• Kanuma® [sebelipase alfa].
• Rezzayo® [rezafungin].
• Zynlonta® [loncastuximab tesirine].

New Preparations: Emylif® orodispersible film [riluzole]; Etacortilen® eye drops [dexamethasone]; Mounjaro KwikPen® [tirzepatide].

Deleted Monographs: Benzoin tincture, compound.

Deleted Preparations: Hibitane® Plus 5% concentrate solution [chlorhexidine]; Zofran® suppository [ondansetron].

12th March 2024

British National Formulary

This update contains 5 significant changes, 1 dose change, 4 new monographs and 2 deleted monographs.

Significant Changes:

Aripiprazole (Abilify® and generic brands): risk of pathological gambling [MHRA/CHM advice].

Empagliflozin: update to advice on use in renal impairment, including new indication for chronic kidney disease.

Quinolones: must now only be prescribed when other commonly recommended antibiotics are inappropriate [MHRA/CHM advice] (see example in ciprofloxacin).

Type 2 diabetes: updated guidance for management.

Vitamin B₁₂: advise patients with known cobalt allergy to be vigilant for sensitivity reactions [MHRA/CHM advice] (advice in cyanocobalamin, hydroxocobalamin; see example in hydroxocobalamin).

Dose Changes:

• Secukinumab [update to dosing for psoriatic arthritis with concomitant moderate to severe plaque psoriasis].

New Monographs:

• Inaqovi® [decitabine with cedazuridine].
• Litfulo® [ritlecitinib].
• Livmarli® [maralixibat].
• Veoza® [fezolinetant].

Deleted Monographs: Cinchocaine hydrochloride with fluocortolone caproate and fluocortolone pivalate; Simvastatin with fenofibrate.

13th February 2024

British National Formulary

This update contains 7 significant changes, 5 new monographs, 2 new preparations, and 3 deleted monographs.

Significant Changes:

• Bromocriptine: updated important safety information.
• Controlled drugs and drug dependence: control of nitrous oxide.
• Insulin degludec (Tresiba®): potential for inappropriate dosing of insulin when switching Tresiba® products [National Patient Safety Alert advice].
• Liraglutide (Saxenda®): vigilance required due to potentially harmful falsified products [MHRA/CHM advice].
• Nirmatrelvir with ritonavir (Paxlovid®): be alert to the risk of drug interactions with ritonavir [MHRA/CHM advice].
• Semaglutide (Ozempic®): vigilance required due to potentially harmful falsified products [MHRA/CHM advice].
• Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients [National Patient Safety Alert advice] (advice in sodium valproate, valproic acid; see example in sodium valproate).

New Monographs:

• Columvi® [glofitamab].
• Domnisol® [calcifediol monohydrate].
• Nexpovio® [selinexor].
• Slynd® [drospirenone].
• Talvey® [talquetamab].

New Preparations: Octasa® MR 1600 mg tablets [mesalazine]; Octasa® suppositories [mesalazine].

Deleted Monographs: Diflucortolone valerate; Fluocinolone acetonide with clioquinol; Fluocinolone acetonide with neomycin.

9th January 2024

British National Formulary

This update contains 6 significant changes, 1 dose change, 4 new monographs and 1 new preparation.

Significant Changes:

• Budesonide with formoterol (Symbicort 200/6 Turbohaler®): updated to include dosing as reliever therapy for mild asthma.
• Co-cyprindiol: update to contra-indications and cautions for use.
• Dexamethasone: clarification of how dosing is expressed for reduction of peri- and neonatal morbidity and mortality.
• Factor IX fraction, dried: name change to factor IX.
• Isotretinoin (Roaccutane®): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age [MHRA/CHM advice].
• Obesity: updated guidance for management.

Dose Changes:

• Duloxetine [update to dosing for major depressive disorder].

New Monographs:

• Aquipta® [atogepant].
• Elfabrio® [pegunigalsidase alfa].
• Spevigo® [spesolimab].
• Voraxaze® [glucarpidase].

New Preparations: Zeyzelf® [rivastigmine].