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Publication Updates

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

11 Jun
British National Formulary logo
BNF June 2019 Update

This update contains 21 significant changes, 1 dose changes and 4 new preparations.

Significant Changes:   

  • Alemtuzumab (Lemtrada®): restriction of use due to serious safety concerns [MHRA/CHM advice].
  • Belimumab (Benlysta®): increased risk of serious psychiatric events seen in clinical trials [MHRA/CHM advice].
  • Brentuximab vedotin for treating CD30-positive cutaneous T-cell lymphoma [NICE guidance].
  • Certolizumab pegol for treating moderate to severe plaque psoriasis [NICE guidance].
  • Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma [NICE guidance].
  • Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 [MHRA/CHM advice] (see elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide).
  • Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 [MHRA/CHM advice] (see elvitegravir with cobicistat, emtricitabine and tenofovir disoproxil).
  • Gabapentin (Neurontin®) and risk of abuse and dependence: new scheduling requirements from 1 April [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.
  • Malaria, prophylaxis: updated country recommendations in the Recommended regimens for prophylaxis against malaria in-line with Public Health England.
  • Malaria, prophylaxis: updated guidance in-line with Public Health England recommendations.
  • Pregabalin (Lyrica®) and risk of abuse and dependence: new scheduling requirements from 1 April [MHRA/CHM advice].
  • Quinolones: new MHRA/CHM advice on restrictions and precautions for use of fluoroquinolone antibiotics.
  • Renal and ureteric stones: new guidance on management.
  • Respiratory system infections, antibacterial therapy: new guidance on management of Cough, acute.
  • Tildrakizumab for treating moderate to severe plaque psoriasis [NICE guidance].
  • Tofacitinib (Xeljanz®): increased risk of pulmonary embolism and mortality in rheumatoid arthritis patients receiving 10 mg twice daily in a clinical trial [MHRA/CHM advice].
  • Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme [MHRA/CHM advice] (see sodium valproate and valproic acid).
  • Yellow fever vaccine, live (Stamaril®) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed [MHRA/CHM advice].
  • Yellow fever vaccine, live (Stamaril®) and fatal adverse reactions: extreme caution needed in those aged 60 years and older [MHRA/CHM advice].

Dose Changes: 

  • Malarone® (atovaquone with proguanil hydrochloride) [update to weight range for prophylaxis of falciparum malaria].

New Preparations: Delstrigo® [lamivudine with tenofovir disoproxil and doravirine], Intrarosa® [prasterone], Pifeltro® [doravirine], Testavan® [testosterone].

 

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

 

14 May
British National Formulary logo
BNF May 2019 Update

This update contains 11 significant changes, 1 dose changes and 5 new preparations.

Significant Changes:   

  • Benralizumab for treating severe eosinophilic asthma [NICE guidance].
  • Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib [NICE guidance].
  • Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes [NICE guidance].
  • Fluoroquinolone antibiotics (ciprofloxacin): new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects [MHRA/CHM advice].
  • Fluoroquinolone antibiotics (levofloxacin, moxifloxacin, ofloxacin): new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects [MHRA/CHM advice].
  • Irinotecan hydrochloride, liposomal formulations (Onivyde®): reports of serious and fatal thromboembolic events [MHRA/CHM advice].
  • Pertuzumab for adjuvant treatment of HER2-positive early stage breast cancer [NICE guidance].
  • Pneumococcal vaccine: updated guidance in-line with Public Health England recommendations.
  • Prescribing in pregnancy: medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed? [MHRA/CHM advice].
  • Respiratory system infections, antibacterial therapy: new guidance for acute exacerbations of Bronchiectasis (non-cystic fibrosis
  • Respiratory system infections, antibacterial therapy: updated guidance for acute exacerbations of Chronic obstructive pulmonary disease.

Dose Changes:

  • Alirocumab [Dosing options for Primary hypercholesterolaemia or mixed dyslipidaemia].

New Preparations: Buvidal® [buprenorphine], Erleada® [apalutamide], Fortacin® [lidocaine with prilocaine], Symkevi® [tezacaftor with ivacaftor], Tegsedi® [inotersen].

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

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