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Publication Updates

08 Jun
British National Formulary logo
British National Formulary June 2021 Update

This update contains 13 significant changes and 7 dose changes.

Significant Changes:
• Atezolizumab (Tecentriq®▼): risk of severe cutaneous adverse reactions (SCARs) [MHRA/CHM advice].

• Esomeprazole: updated breast feeding statement.

• Hypoglycaemia: updated guidance.

• Immune thrombocytopenic purpura: updated guidance.

• Lansoprazole: updated breast feeding statement.

• Life support algorithm (image): adult advanced life support algorithm image updated.

• Pantoprazole: updated breast feeding statement.

• Polycystic ovary syndrome: updated guidance on management.

• Polyethylene glycol (PEG) laxatives and starch-based thickeners: potential interactive effect when mixed, leading to an increased risk of aspiration [MHRA/CHM advice] (advice in macrogol 3350, macrogol 3350 with anhydrous sodium sulfate, ascorbic acid, potassium chloride, sodium ascorbate and sodium chloride, macrogol 3350 with anhydrous sodium sulfate, potassium chloride, sodium bicarbonate and sodium chloride, macrogol 3350 with potassium chloride, sodium bicarbonate and sodium chloride; see example in macrogol 3350).

• Prescribing in dental practice: updated guidance on the management of hypoglycaemia.

• Rabeprazole sodium: updated breast feeding statement.

• Sodium nitrite: risk of death from unintended administration of sodium nitrite [NPSA advice].

• Tofacitinib (Xeljanz®▼): initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF-alpha inhibitors [MHRA/CHM advice].

Dose Changes:
• Amiodarone hydrochloride [update to dosing for the treatment of ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation (for cardiopulmonary resuscitation)].

Budenofalk® capsules and granules (budesonide) [update to dosing for microscopic colitis].

• Canagliflozin [update to dosing in renal impairment].

Entocort® capsules (budesonide) [update to dosing for microscopic colitis].

• Glucose [update to dosing for hypoglycaemia].

• Medical emergencies in the community [update to dosing of glucose for hypoglycaemia].

• Naloxone hydrochloride [update to dosing for treatment of acute opioid overdosage including high- and low-dose regimens].

For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm

11 May
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British National Formulary May 2021 Update

This update contains 5 significant changes, 1 dose change, 1 new monograph, 1 new preparation and 7 deleted monographs.

Significant Changes:
• Anthrax: updated guidance.

• Bendamustine hydrochloride (Levact®): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML) [MHRA/CHM advice].

• Botulism antitoxin: updated guidance.

• Pneumococcal vaccine: new guidance added on prioritisation of the 23-valent pneumococcal vaccine while supplies remain limited.

• Poisoning, emergency treatment: new guidance on storage of specialist antidotes.

Dose Change:
• Talazoparib [dose adjustments due to interactions updated].

New Monograph:
Enhertu® [trastuzumab deruxtecan].

New Preparation:
• Angusta® [misoprostol].

Deleted Monographs:
Danazol; Dexibuprofen; Glibenclamide; Nateglinide; Necitumumab; Paracetamol with metoclopramide; Saquinavir.

For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm

13 Apr
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British National Formulary April 2021 Update

This update contains 25 significant changes, 5 dose changes, 2 new monographs, 1 new preparation and 8 deleted monographs.

Significant Changes:

• Brolucizumab for treating wet age-related macular degeneration [NICE guidance].

• Buprenorphine with naloxone (Suboxone®) sublingual film as substitution treatment for opioid drug dependence [SMC guidance].

• Contraceptives, hormonal: updated guidance in-line with Faculty of Sexual and Reproductive Healthcare recommendations for progestogen-only contraceptives.

• COVID-19: updated guidance.

• COVID-19 vaccine: updated guidance in-line with Public Health England recommendations.

• Dapagliflozin for treating chronic heart failure with reduced ejection fraction [NICE guidance].

• Filgotinib for treating moderate to severe rheumatoid arthritis [NICE guidance].

• Formoterol fumarate with glycopyrronium and budesonide (Trixeo Aerosphere®) for the maintenance treatment in adults with moderate to severe chronic obstructive pulmonary disease who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist [SMC guidance].

• Hepatitis B vaccine: updated guidance in-line with Public Health England recommendations.

• Hydrocortisone (Alkindi®): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules [MHRA/CHM advice].

• Immunoglobulins: updated guidance in-line with Public Health England recommendations for the use of hepatitis B immunoglobulin.

• Iron isomaltoside 1000: name change to ferric derisomaltose.

• Leuprorelin acetate (Prostap® DCS) as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence [SMC guidance].

• Leuprorelin acetate (Prostap® DCS) as treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation [SMC guidance].

• Mepolizumab for treating severe eosinophilic asthma [NICE guidance].

• Metreleptin for treating lipodystrophy [NICE guidance].

• Niraparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy [NICE guidance].

• Ozanimod (Zeposia®) for the treatment of adult patients with relapsing remitting multiple sclerosis [SMC guidance].

• Pregabalin (Lyrica®): reports of severe respiratory depression [MHRA/CHM advice].

• Prescribing in breast-feeding: Medicines in pregnancy and breastfeeding–new initiative for consistent guidance; report on optimising data for medicines used during pregnancy [MHRA/CHM advice].

• Prescribing in pregnancy: Medicines in pregnancy and breastfeeding–new initiative for consistent guidance; report on optimising data for medicines used during pregnancy [MHRA/CHM advice].

• Ravulizumab (Ultomiris®) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria [SMC guidance].

• Trabectedin for the treatment of advanced soft tissue sarcoma [updated NICE guidance].

• Ulipristal acetate 5 mg (Esmya®): further restrictions due to risk of serious liver injury [MHRA/CHM].

• Upadacitinib (Rinvoq®) for treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs [SMC guidance].

Dose Changes:

• Dexamethasone [update to dosing for adjunctive treatment of suspected bacterial meningitis].

• Dexamethasone [update to dosing for the treatment of severe or critical COVID-19].

• Dexamethasone [update to dosing for treatment of life-threatening cerebral oedema].

• Dulaglutide [update to dosing for treatment of type 2 diabetes mellitus in combination with insulin or other antidiabetic drugs].

• Niraparib [update to dosing for ovarian, fallopian, and peritoneal cancer].

New Monographs:

Myalepta® [metreleptin].

• Von Willebrand factor.

New Preparations: Suboxone® sublingual film [buprenorphine with naloxone].

Deleted Monographs: Cenegermin; Dasabuvir; Dihydrotachysterol; Hydrocortisone with pramocaine; Meprobamate; Methylcellulose; Ombitasvir with paritaprevir and ritonavir; Tetrastarch.

For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm

09 Mar
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British National Formulary March 2021 Update

This update contains 17 significant changes, 7 dose changes and 3 new monographs.

Significant Changes:
• Aminoglycosides: increased risk of deafness in patients with mitochondrial mutations [MHRA/CHM advice] (advice in amikacin, gentamicin, gentamicin with hydrocortisone, neomycin sulfate, tobramycin; see example in gentamicin).

• Brentuximab vedotin (Adcetris®) in combination with cyclophosphamide, doxorubicin and prednisone for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) [SMC guidance].

• Brigatinib (Alunbrig®) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor [SMC guidance].

• Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor [NICE guidance].

• Daratumumab (Darzalex®) in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant [SMC guidance].

• Daratumumab subcutaneous injection (Darzalex®) in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant [SMC guidance].

• Entrectinib (Rozlytrek®) for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS-1 inhibitors [SMC guidance].

• Epilepsy: updated advice on antiepileptic drugs in pregnancy following comprehensive safety review [MHRA/CHM advice].

• Erythromycin: updated pregnancy statement.

• Fostamatinib (Tavlesse®) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments [SMC guidance].

• Oropharyngeal infections, antibacterial therapy: updated guidance on management.

• Psychoses and related disorders: updated guidance on management.

• Secukinumab (Cosentyx®) for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs [SMC guidance].

• Skin infections, antibacterial therapy: updated guidance for the management of human and animal bites.

• SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery [MHRA/CHM advice] (advice in citalopram, escitalopram, fluoxetine, fluvoxamine maleate, paroxetine, sertraline, venlafaxine; see example in fluoxetine).

• Trifluridine with tipiracil for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after 2 or more therapies [NICE guidance].

• Vortioxetine: SSRI/SNRI antidepressant medicines; small increased risk of postpartum haemorrhage when used in the month before delivery [MHRA/CHM advice].

Dose Changes:
• Atropine sulfate [update to dosing for treatment of symptomatic bradycardia due to acute overdosage of beta-blockers].

• Glucagon [update to dosing for treatment of severe hypotension, heart failure or cardiogenic shock due to acute overdosage of beta-blockers].

• Neratinib [dose adjustments due to interactions updated].

• Normal immunoglobulin [update to dosing for post-exposure prophylaxis against hepatitis A infection].

• Rosuvastatin [dose adjustments due to interactions updated].

• Secukinumab [update to dosing for spondyloarthritis].

• Vitamins A and D 4000 units/400 units [child age range].

New Monographs:
Bevespi Aerosphere® [glycopyrronium with formoterol fumarate].

Phesgo® [pertuzumab with trastuzumab].

Trixeo Aerosphere® [formoterol fumarate with glycopyrronium and budesonide].

For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.ht

09 Feb
British National Formulary logo
British National Formulary February 2021 Update

This update contains 20 significant changes and 2 new monographs.

Significant Changes:
• Andexanet alfa (Ondexxya®): avoid use of andexanet prior to heparinisation [MHRA/CHM advice].

• Atezolizumab with bevacizumab for treating advanced or unresectable hepatocellular carcinoma [NICE guidance].

• Avatrombopag (Doptelet®) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure [SMC guidance].

• Bempedoic acid (Nilemdo®) in adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies; or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated [SMC guidance].

• Caplacizumab with plasma exchange and immunosuppression for treating acute acquired thrombotic thrombocytopenic purpura [NICE guidance].

• COVID-19: updated guidance.

• COVID-19 vaccine: new guidance in-line with Public Health England recommendations.

• Dimethyl fumarate (Tecfidera®): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia [MHRA/CHM advice].

• Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban [MHRA/CHM advice].

• Fingolimod (Gilenya®): updated advice about the risks of serious liver injury and herpes meningoencephalitis [MHRA/CHM advice].

• Immunisation schedule: updated National flu immunisation programme in-line with Public Health England recommendations.

• Influenza vaccine: updated guidance in-line with Public Health England recommendations.

• Liraglutide for managing overweight and obesity [NICE guidance].

• Methylprednisolone as sodium succinate (Solu-Medrone®) 40 mg powder and solvent for solution for injection: change from lactose-containing to a lactose-free formulation; risk of serious allergic reactions if formulations are confused [MHRA/CHM advice].

• Mexiletine (Namuscla®) for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders [SMC guidance].

• Quinolones (systemic and inhaled fluoroquinolones): small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk [MHRA/CHM advice] (advice in ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin; see example in ciprofloxacin).

• Rheumatoid arthritis: updated guidance on management.

• Upadacitinib for treating severe rheumatoid arthritis [NICE guidance].

• Venetoclax (Venclyxto®) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) [SMC guidance].

• Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia [NICE guidance].

New Monographs:

• COVID-19 vaccine.

• Treprostinil.

For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm

12 Jan
British National Formulary logo
British National Formulary January 2021 Update

This update contains 25 significant changes, 9 dose changes, 5 new monographs, 3 new preparations, 3 deleted monographs and 3 deleted preparations.

Significant Changes: 
• Antibacterials, use for prophylaxis: updated guidance for the prevention of secondary Haemophilus influenzae type b disease.

• Atezolizumab (Tecentriq®) in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer [SMC guidance].

• Atezolizumab (Tecentriq®) in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression at a level of 1 % or more and who have not received prior chemotherapy for metastatic disease [SMC guidance].

• Avatrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure [NICE guidance].

• Bupropion hydrochloride (Zyban®): risk of serotonin syndrome with use with other serotonergic drugs [MHRA/CHM advice].

• Carfilzomib for previously treated multiple myeloma [NICE guidance].

• Darolutamide (Nubeqa®) for the treatment of adult men with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease [SMC guidance].

• Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer [NICE guidance].

• Darunavir with cobicistat (Rezolsta®) in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg) [AWMSG guidance].

• Eye: updated guidance for expiration of eye preparations.

• Ferric carboxymaltose (Ferinject®▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures [MHRA/CHM advice].

• Frequently asked questions—clinical: updated guidance for expiration of eye preparations.

• Galcanezumab for preventing migraine [NICE guidance].

• Interactions: drugs that cause myelosuppression: pharmacodynamic effects drug group revalidated and updated.

• Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma [NICE guidance].

• Modafinil (Provigil®): increased risk of congenital malformations if used during pregnancy [MHRA/CHM advice].

• National funding decisions: advice from NICE, SMC, and AWMSG now briefly referenced in relevant monographs—funding body website should be accessed for full details; see Guidance on prescribing.

• Patiromer calcium (Veltassa®) for the treatment of hyperkalaemia in adults [SMC guidance].

• Pembrolizumab for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma [NICE guidance].

• Pirfenidone (Esbriet®): risk of serious liver injury; updated advice on liver function testing [MHRA/CHM advice].

• Romosozumab (Evenity®) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture [SMC guidance].

• Siponimod for treating secondary progressive multiple sclerosis [NICE guidance].

• Trabectedin (Yondelis®) for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents [SMC guidance].

• Trastuzumab emtansine (Kadcyla®) as a single agent, for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy [SMC guidance].

• Vaccination, general principles: updated guidance.

Dose Changes:

Clinorette® (estradiol with norethisterone) [update to dosing].

Elleste-Duet® Conti (estradiol with norethisterone) [update to dosing].

Evorel® Conti (estradiol with norethisterone) [update to dosing].

Evorel® Sequi (estradiol with norethisterone) [update to dosing].

Kliofem® (estradiol with norethisterone) [update to dosing].

Kliovance® (estradiol with norethisterone) [update to dosing].

Novofem® (estradiol with norethisterone) [update to dosing].

• Sumatriptan [update to dosing for treatment of acute migraine].

Trisequens® (estradiol with norethisterone) [update to dosing].

New Monographs:

Calquence®▼ [acalabrutinib].

Doptelet® [avatrombopag].

Enerzair Breezhaler® [mometasone furoate with glycopyrronium bromide and indacaterol].

Otigo® [phenazone with lidocaine].

Zeposia® [ozanimod].

New Preparations: Lecicarbon A® [sodium acid phosphate with sodium bicarbonate]; Lecicarbon C® [sodium acid phosphate with sodium bicarbonate]; Symbicort® 100 micrograms/3 micrograms per actuation pressurised inhalation [budesonide with formoterol].

Deleted Monographs: Sodium stibogluconate; Telbivudine; Ticarcillin with clavulanic acid.

Deleted Preparations: Climagest® 1 mg [estradiol with norethisterone]; Climagest® 2 mg [estradiol with norethisterone]; Climesse® [estradiol with norethisterone].

For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm

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