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Publication Updates

14 Sep
British National Formulary logo
British National Formulary September 2021 Update

This update contains 6 significant changes and 4 new monographs.

Significant Changes:
• Chloramphenicol eye drops containing borax or boric acid buffers: use in children younger than 2 years [MHRA/CHM advice].

• Low back pain and sciatica: updated guidance on management.

• Migraine: updated guidance on preventative migraine treatment.

• Oral retinoid medicines: temporary monitoring advice during coronavirus (COVID-19) pandemic [MHRA/CHM advice] (advice in acitretin, alitretinoin, isotretinoin; see example in isotretinoin).

• Pain, Chronic: updated guidance on management.

• Venetoclax (Venclyxto®): updated recommendations on tumour lysis syndrome (TLS) in CLL patients [MHRA/CHM advice].

New Monographs:
Dropizol® [opium].

Evrysdi® [risdiplam].

Fintepla® [fenfluramine].

Inrebic® [fedratinib].

For further details on changes in the BNF click on https://www.medicinescomplete.com/#/content/bnf/PHP107699

10 Aug
British National Formulary logo
British National Formulary August 2021 Update

This update contains 9 significant changes, 1 dose change, 4 new monographs, 1 new preparation and 1 deleted monograph.

Significant Changes:
• Adrenal insufficiency: updated guidance on management.

• Atezolizumab (Tecentriq®) and other immune-stimulatory anti-cancer drugs: risk of severe cutaneous adverse reactions (SCARs) [MHRA/CHM advice] (advice in atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab; see example in atezolizumab).

• CDK4/6 inhibitors: reports of interstitial lung disease and pneumonitis, including severe cases [MHRA/CHM advice] (advice in abemaciclib, palbociclib, ribociclib; see example in abemaciclib).

• Corticosteroids, replacement therapy: title changed to Adrenal insufficiency.

• COVID-19 vaccine: reports of myocarditis and pericarditis with the Pfizer/BioNTech and Moderna vaccines.

• Heavy menstrual bleeding: updated guidance.

• Immunoglobulins: updated guidance in-line with Public Health England recommendations for the use of immunoglobulin for tetanus infection and prophylaxis.

• Prescribing in renal impairment: updated guidance.

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

Dose Change:
Enstilar® (calcipotriol with betamethasone) [update to dosing for the treatment of psoriasis].

New Monographs:
Blenrep® [belantamab mafodotin].

Isturisa® [osilodrostat].

Kesimpta® [ofatumumab].

Zibor® [bemiparin sodium].

New Preparation: Fixkoh Airmaster® [fluticasone with salmeterol].

Deleted Monograph: Telavancin.

For further details on changes in the BNF click on https://www.medicinescomplete.com/#/content/bnf/PHP107699

13 Jul
British National Formulary logo
British National Formulary July 2021 Update

This update contains 14 significant changes, 1 dose change, 2 new monographs and 4 deleted monographs.

Significant Changes:
• Acute coronary syndromes: updated guidance on management.

• Aflibercept (Eylea® solution for intravitreal injection): higher risk of intraocular pressure increase with the pre-filled syringe [MHRA/CHM advice].

• Contraceptives, interactions: updated guidance.

• COVID-19: updated guidance.

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

• Eczema: updated guidance on the management of infection.

• Emergency contraception: updated guidance.

• Estradiol [dosing added for the prophylaxis of recurrent urinary-tract infection in postmenopausal women].

• Estriol [dosing added for the prophylaxis of recurrent urinary-tract infection in postmenopausal women].

• Levothyroxine sodium: new prescribing advice for patients who experience symptoms on switching between different levothyroxine products [MHRA/CHM advice].

• Oral anticoagulants: updated guidance in overview and addition of new guidance for direct-acting oral anticoagulants.

• Rabies vaccine: addition of new guidance for post-exposure management.

• Skin infections, antibacterial therapy: new guidance for the management of secondary bacterial infection of common skin conditions.

• Vitamins: addition of new guidance for vitamin D.

Dose Changes:
• Perampanel [update to include dosing in children from 4 years old for treatment of focal seizures and from 7 years old for primary generalised tonic-clonic seizures].

New Monographs:
Leqvio® [inclisiran].

Retsevmo® [selpercatinib].

Deleted Monographs: Emollient bath and shower products, tar-containing; Ergotamine tartrate with caffeine hydrate and cyclizine hydrochloride; Fluphenazine decanoate; Sodium aurothiomalate.

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

08 Jun
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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
British National Formulary logo
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
British National Formulary logo
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

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