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Publication Updates

10 Dec
British National Formulary logo
BNF December 2019 Update

This update contains 11 significant changes, 4 new preparations, and 1 new monograph.

Significant Changes:   

  • Adrenaline/epinephrine auto-injectors: recent action taken to support safety [MHRA/CHM advice]. 
  • Bacillus Calmette-Guérin vaccine: updated guidance in-line with Public Health England recommendations. 
  • Botulinum toxin type A for treating chronic sialorrhea [NICE guidance]. 
  • Idelalisib for treating refractory follicular lymphoma [NICE guidance]. 
  • Ingenol mebutate gel (Picato®): increased incidence of skin tumours seen in some clinical studies [MHRA/CHM advice]. 
  • Lanadelumab for preventing recurrent attacks of hereditary angioedema [NICE guidance]. 
  • Nivolumab (Opdivo®): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation [MHRA/CHM advice]. 
  • Prescribing in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions [MHRA/CHM advice]. 
  • Respiratory system infections, antibacterial therapy: updated guidance for community-acquired pneumonia. 
  • Respiratory system infections, antibacterial therapy: updated guidance for hospital-acquired pneumonia. 
  • Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease [NICE guidance]. 

New Preparations: Cablivi® [caplacizumab], Lamivudine with tenofovir disoproxil, Rizmoic® [naldemedine], Takhzyro® [lanadelumab]. 

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

12 Nov
British National Formulary logo
BNF November 2019 Update

This update contains 11 significant changes, 2 dose changes and 7 new preparations. 

Significant Changes:  

  • Benralizumab for treating severe eosinophilic asthma (updated advice) [NICE guidance]. 
  • Fingolimod (Gilenya®): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception [MHRA/CHM advice].
  • Hormone replacement therapy (HRT) (conjugated oestrogens (equine) and estradiol): further information on the known increased risk of breast cancer with HRT and its persistence after stopping [MHRA/CHM advice]. 
  • Human papillomavirus vaccine updated guidance in-line with Public Health England recommendations.
  • Hypertension: updated guidance on the management of hypertension in pregnancy.
  • Immunisation schedule: updated national human papillomavirus immunisation programme in-line with Public Health England recommendations.
  • Mitomycin (Mitomycin-C Kyowa® 40 mg): restricted to intravesical administration only for treatment of superficial bladder cancer [MHRA/CHM advice].
  • Montelukast (Singulair®): reminder of the risk of neuropsychiatric reactions [MHRA/CHM advice].
  • Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer [NICE guidance].
  • Pentosan polysulfatesodium (Elmiron®): rare risk of pigmentary maculopathy [MHRA/CHM advice]. 
  • Sodium zirconium cyclosilicate for treating hyperkalaemia [NICE guidance].
     

Dose Changes:  

  • Magnesium sulfate: Change to additional dose for seizure recurrence in pre-eclampsia and eclampsia.
  • Human papillomavirus vaccines: Dosing now includes male patients.

 

New Preparations:  
Dupixent® [dupilumab], Gardasil 9® [human papillomavirus vaccines], Lorviqua® [lorlatinib], Nyxoid® [naloxone hydrochloride], Talzenna® [talazoparib], Vitrakvi® [larotrectinib], Waylivra® [volanesorsen]. 

 

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

 

08 Oct
British National Formulary logo
BNF October 2019 Update

This update contains 16 significant changes, 1 dose change and 5 new preparations.

Significant Changes: 

  • Carfilzomib (Kyprolis®): reminder of risk of potentially fatal cardiac events [MHRA/CHM advice].
  • Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma [NICE guidance].
  • Dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer [NICE guidance].
  • Dapagliflozin with insulin for treating type 1 diabetes [NICE guidance].
  • Daratumumab (Darzalex®): risk of reactivation of hepatitis B virus [MHRA/CHM advice].
  • Hyperparathyroidism : New guidance on management of primary hyperparathyroidism.
  • Naltrexone with bupropion (Mysimba®): risk of adverse reactions that could affect ability to drive [MHRA/CHM advice].
  • Olaparib for maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy [NICE guidance].
  • Patisiran for treating hereditary transthyretin amyloidosis [NICE guidance].
  • Pentosan polysulfate sodium (Elmiron®): risk of pigmentary maculopathy [MHRA/CHM advice].
  • Prostate Cancer : updated guidance on management.
  • Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative, advanced breast cancer [NICE guidance].
  • Risankizumab for treating moderate to severe plaque psoriasis [NICE guidance].
  • Rotavirus vaccine : updated guidance in-line with Public Health England recommendations.
  • Ulcerative colitis : updated guidance on management.
  • Vedolizumab for treating moderately to severely active ulcerative colitis [NICE guidance].

Dose Changes:

  • Vitamin B substances with ascorbic acid : Duration and route for the treatment of suspected or established Wernicke’s encephalopathy, and prophylaxis of Wernicke’s encephalopathy updated (BNF only).

New Preparations: Dovato® [ lamivudine with dolutegravir ], Emgality® [ galcanezumab ], Libtayo® [ cemiplimab ], Ondexxya® [ andexanet alfa ], Onpattro® [ patisiran ].

 

For further details on changes in the BNF click on

http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm

10 Sep
British National Formulary logo
BNF September 2019 Update

This update contains 11 significant changes, 1 dose change and 3 new preparations.

Significant Changes: 

  • Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity [NICE guidance].
  • Febuxostat (Adenuric®): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease [MHRA/CHM advice].
  • Fluocinolone acetonide intravitreal implant for treating recurrent non-infectious uveitis [NICE guidance].
  • Letermovir for preventing cytomegalovirus disease after a stem cell transplant [NICE guidance].
  • Migraine: updated guidance on management.
  • Nusinersen for treating spinal muscular atrophy [NICE guidance].
  • Rivaroxaban (Xarelto®): reminder that 15 mg and 20 mg tablets should be taken with food [MHRA/CHM advice].
  • Stroke: updated guidance on management.
  • Tocilizumab (RoActemra®): rare risk of serious liver injury including cases requiring transplantation [MHRA/CHM advice].
  • Typhoid vaccine: updated guidance in line with Public Health England recommendations.
  • Urinary-tract infections: updated guidance on management.

 

Dose Changes:

  • Typhoid vaccine [booster dose added].

 

New Preparations: Imvaggis® pessary [estriol], Ledaga® gel [chlormethine], Renoxitin® [cefoxitin].

 

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

 

13 Aug
British National Formulary logo
BNF August 2019 Update

This update contains 14 significant changes, 1 dose change and 6 new preparations. 

Significant Changes:

  • Atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer [NICE guidance]. 
  • Contraceptives, hormonal: updated guidance on combined hormonal contraceptives. 
  • Crohn’s disease: updated guidance on management. 
  • 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]. 
  • Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes [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 the treatment of multiple myeloma in people who have received at least 2 prior therapies [NICE guidance]. 
  • Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality [NICE guidance]. 
  • 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]. 
  • Ocrelizumab for treating primary progressive multiple sclerosis [NICE guidance]. 
  • Olaratumab (Lartruvo®): withdrawal of the EU marketing authorisation due to lack of efficacy [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]. 
  • Urinary incontinence and pelvic organ prolapse in women: updated guidance on management. 

Dose Changes:

  • Epipen® preparations (adrenaline/epinephrine) [body-weight ranges for children’s dosing updated].

New Preparations: Ajovy® [fremanezumab], Glyxambi® [empagliflozin with linagliptin], Brinavess® [vernakalant], Vizimpro® [dacomitinib], Betesil® [betamethasone], Blissel® [estriol].

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

 

09 Jul
British National Formulary logo
BNF July 2019 Update

This update contains 9 significant changes, 2 dose changes and 5 new preparations.

Significant Changes:   

  • Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy [NICE guidance].
  • Alemtuzumab (Lemtrada®) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements [MHRA/CHM advice].
  • Cerebral palsy and spasticity: inclusion of overview.
  • Durvalumab for treating locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation [NICE guidance].
  • Enzalutamide for hormone-relapsed non-metastatic prostate cancer [NICE guidance].
  • Inotersen for treating hereditary transthyretin amyloidosis [NICE guidance].
  • Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy [MHRA/CHM advice].
  • Nivolumab with ipilimumab for untreated advanced renal cell carcinoma [NICE guidance].
  • Tofacitinib (Xeljanz®): restriction of 10 mg twice daily dose in patients at high risk of pulmonary embolism while safety review is ongoing [MHRA/CHM advice].

Dose Changes: 

  • Emicizumab [alternative dosing for existing indications added].
  • Pembrolizumab [alternative dosing for monotherapy indications added].

New Preparations: Cuprior® [trientine dihydrochloride], Jorveza® [budesonide], Lokelma® [sodium zirconium cyclosilicate], Renapime® [cefepime], Skyrizi® [risankizumab]. 

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

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