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Publication Updates

08 Oct
British National Formulary logo
BNF October 2018 update

This update contains 9 significant changes, 2 dose changes and 4 new preparations.

Significant Changes: 

  • Side-effects and their further information sections have been reviewed against the current product literature and terms used to define these have been standardised across all drug monographs for this update.
  • Alectinib for untreated ALK-positive advanced non-small-cell lung cancer [NICE guidance] (BNF only).
  • Dinutuximab beta for treating neuroblastoma [NICE guidance].
  • Dupilumab for treating moderate to severe atopic dermatitis [NICE guidance] (BNF only).
  • Ear, Ear infections, antibacterial therapy: updated guidance on management of otitis media.
  • Heavy menstrual bleeding: updated guidance on management.
  • Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs [NICE guidance] (BNF only).
  • Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine [NICE guidance] (BNF only).
  • Nusinersen (Spinraza®): reports of communicating hydrocephalus not related to meningitis or bleeding [MHRA/CHM advice].

Dose Changes:

  • Golimumab [maintenance dose for patients with ulcerative colitis and body-weight less than 80␣kg] (BNF only).
  • Rufinamide [update to age range for use in children and dosing information for use with valproate].

New Preparations: Biktarvy® [bictegravir with emtricitabine and tenofovir alafenamide] (BNF only); Diclofenac mouthwash [diclofenac] (BNF only); Elmiron® [pentosane polysulfate sodium] (BNF only); Qarziba® [dinutuximab beta].           

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

14 Sep
British National Formulary logo
BNF September 2018 update

This update contains 16 significant changes and 6 dose changes.

Significant Changes:

  • Atezolizumab for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable [NICE guidance].
  • Cenegermin for treating neurotrophic keratitis [NICE guidance].
  • Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer [NICE guidance].
  • Darunavir boosted with cobicistat (darunavir with cobicistat): avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 [MHRA/CHM advice].
  • Darunavir boosted with cobicistat (darunavir with cobicistat, emtricitabine and tenofovir alafenamide): avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 [MHRA/CHM advice].
  • Eltrombopag (Revolade®): reports of interference with bilirubin and creatinine test results [MHRA/CHM advice].
  • Interferon beta and glatiramer acetate for treating multiple sclerosis [NICE guidance].
  • Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer [NICE guidance].
  • Nivolumab for treating locally advanced unresectable or metastatic urothelial cancer after platinum-containing chemotherapy [NICE guidance].
  • Ocrelizumab for treating relapsing–remitting multiple sclerosis [NICE guidance].
  • Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confused [MHRA/CHM advice].
  • Pembrolizumab for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable [NICE guidance].
  • Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer [NICE guidance].
  • Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects [MHRA/CHM advice], see Respiratory system, drug delivery.
  • Stable angina: updated guidance on management.
  • Ulipristal acetate (Esmya®) for symptoms of uterine fibroids: restrictions to use and requirement to check liver function before, during and after treatment [MHRA/CHM advice].
  • Venous thromboembolism: updated guidance on prophylaxis.Dose Changes:
  • Anakinra [dosing in severe renal impairment].
  • Dasatinib [addition of information on dose adjustment due to side-effects].
  • Esmya® (ulipristal acetate) [dosing information for pre-operative treatment of moderate to severe symptoms of uterine fibroids].
  • Hexetidine [update to age-range for use in children].
  • Hydroxocobalamin [frequency of maintenance dosing for macrocytic anaemia without neurological involvement].
  • Hydroxocobalamin [frequency of maintenance dosing for pernicious anaemia without neurological involvement].

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

14 Aug
British National Formulary logo
BNF August 2018 update

This update contains 18 significant changes, 3 new preparations and 9 dose changes. 

Significant Changes:  

  • Age-related macular degeneration: updated guidance on management.
  • Arsenic trioxidefor treating acute promyelocytic leukaemia [NICE guidance]. 
  • Atezolizumabfor treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy [NICE guidance]. 
  • Brentuximab vedotinfor treating CD30-positive Hodgkin lymphoma [NICE guidance]. 
  • Cardiovascular disease risk assessment and prevention: updated guidance.
  • Denosumab(Xgeva®) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronate [MHRA/CHM advice]. 
  • Denosumab(Xgeva®) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation [MHRA/CHM advice]. 
  • Diabetic complications: updated guidance.
  • Dolutegravir(Tivicay®, Triumeq®, Juluca®): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception [MHRA/CHM advice]. 
  • Donepezil hydrochloride, galantamine, rivastigmine, and memantine hydrochloridefor the treatment of Alzheimer’s disease [NICE guidance]. 
  • Dyslipidaemias: updated guidance on familial hypercholesterolaemia.
  • Glaucoma and ocular hypertension: updated guidance on management.
  • Guselkumabfor treating moderate to severe plaque psoriasis [NICE guidance]. 
  • Lynparza® (olaparib): risk of medication errors with new pharmaceutical form [MHRA/CHM advice].
  • Midostaurinfor untreated acute myeloid leukaemia [NICE guidance]. 
  • Oropharyngeal infections, antibacterial therapy: updated guidance on sore throat (acute).
  • Pembrolizumabfor untreated locally advanced or metastatic urothelial cancer when cisplatin is unsuitable [NICE guidance]. 
  • Vaccines: updated guidance for Meningococcal group B vaccines.

Dose Changes: 

  • Canakinumab.
  • Ceritinib[dose and directions for administration]. 
  • Ciclosporin[rheumatoid arthritis indication and dose]. 
  • Collagenase[dosing statement for Dupuytren’s contracture]. 
  • Ferric maltol[indication]. 
  • Haloperidol.
  • Haloperidol decanoate.
  • Mometasone furoate[prophylaxis and treatment of seasonal allergic or perennial rhinitis— age range extended in children]. 
  • Vancomycin[deletion of the statement recommending the use of ideal body-weight to calculate intravenous doses in obese patients]. 

New PreparationsJuluca® [dolutegravir with rilpivirine], Kelhale® [beclometasone dipropionate], Lynparza® tablets [olaparib]. 

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

10 Jul
British National Formulary logo
BNF July 2018 update

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

Significant Changes: 

  • Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy [NICE guidance].
  • Avelumab for treating metastatic Merkel cell carcinoma [NICE guidance].
  • Braltus® (tiotropium): risk of inhalation of capsule if placed in the mouthpiece of the inhaler [MHRA/CHM advice].
  • Daclizumab (Zinbryta®) — marketing authorisation withdrawn for safety reasons.
  • Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy [NICE guidance].
  • Tivicay® (dolutegravir), Triumeq® (dolutegravir, abacavir, lamivudine), Juluca® (dolutegravir, rilpivirine): neural tube defects reported in infants born to women exposed to dolutegravir at the time of conception [MHRA/CHM advice].
  • Tocilizumab for treating giant cell arteritis [NICE guidance].

Dose Changes:

  • Amitriptyline hydrochloride [doses for depression, neuropathic pain and migraine prophylaxis].
  • Ganciclovir.
  • Ivabradine.
  • Macrogol 3350 with potassium chloride, sodium bicarbonate and sodium chloride.
  • Sildenafil Digital ulcers associated with systemic sclerosis [unlicensed].
  • Tadalafil [clarification of dosing for intermittent use in erectile dysfunction and dosing in hepatic and renal impairment].
  • Vancomycin.

New Preparations: Mylotarg® [gemtuzumab ozogamicin], Synagis® [palivizumab]

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 2018 update

This update contains 11 significant changes, 5 new preparations and 6 dose changes. 

Significant Changes:

Asthma, chronic: updated guidance on management.
Brodalumab for treating moderate to severe plaque psoriasis [NICE guidance]
Cabozantinib for treating medullary thyroid cancer [NICE guidance].
Eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy regimen [NICE guidance].
Immunoglobulins: updated guidance for Varicella-zoster immunoglobulin.
Obeticholic acid (Ocaliva®): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring [MHRA/CHM advice].
Obinutuzumab for untreated advanced follicular lymphoma [NICE guidance].
Quinine: clarification of parenteral dose for the treatment of malaria [dose reduction necessary if parenteral treatment is required for more than 48 hours].
Regorafenib for previously treated advanced hepatocellular carcinoma [NICE guidance].
Vaccines: updated guidance for Hepatitis A Vaccine.
Vaccines for travel: updated guidance on Hepatitis A.

Dose changes:

Bosutinib [update to dose in renal impairment].
Candesartan cilexetil [clarification of maximum daily dose in heart failure].
Dexibuprofen.
Haloperidol [clarification of continuous subcutaneous dose for nausea and vomiting in palliative care].
Nivolumab [doses for monotherapy].
Temocillin.

New Preparations:

AirFluSal® preparations [fluticasone with salmeterol], Fasenra® [benralizumab], Hemlibra® preparations [tocilizumab], Rydapt® [midostaurin].

For further details on changes in the BNF click on changes.

14 May
British National Formulary logo
BNF May 2018 update

This update contains 15 significant changes, 7 new preparations and 6 dose changes

Significant Changes:

  • Alendronic acid, ibandronic acid, risedronate sodium and zoledronic acid for treating osteoporosis [updated NICE guidance].
  • Cystic fibrosis: updated guidance.
  • Daratumumab monotherapy for treating relapsed and refractory multiple myeloma [NICE guidance].
  • Esmya® (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users [MHRA/CHM advice].
  • Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma [NICE guidance].
  • Noradrenaline/norepinephrine 0.08 mg/mL (4 mg in 50 mL) solution for infusion association with potential risk of medication errors.
  • Osteoporosis: updated guidance.
  • Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer [NICE guidance].
  • Pirfenidone for treating idiopathic pulmonary fibrosis [NICE guidance].
  • Raloxifene hydrochloride and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women [updated NICE guidance].
  • Raloxifene hydrochloride for the primary prevention of osteoporotic fragility fractures in postmenopausal women [updated NICE guidance].
  • Skin infections: head lice eradication products: risk of serious burns if treated hair is exposed to open flames or other sources of ignition [MHRA/CHM advice].
  • Sofosbuvir with velpatasvir and voxilaprevir for treating chronic hepatitis C [NICE guidance].
  • Terbinafine: clarification of hepatic monitoring advice.
  • Valproic acid and sodium valproate: valproate medicines contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met [MHRA/CHM advice].

Dose Changes:

  • Abatacept [update to dosing advice].
  • Daptomycin [update to dosing advice].
  • Levonorgestrel [update to effective duration for Levosert® intra-uterine device].
  • Levonorgestrel [update to timing for emergency contraception].
  • Nilotinib [update to dosing advice].
  • Sodium thiosulfate.

New Preparations:

Cetraxal ® [ciprofloxacin ear drops], Chenodeoxycholic acid [chenodeoxycholic acid capsules], Kyleena ® [levonorgestrel intrauterine device], NACSYS ® [acetylcysteine effervescent tablets], Skudexa ® [tramadol with dexketoprofen], Testogel ® 16.2 mg [testosterone gel], Xylonor ® [lidocaine with cetrimide].

For further details on changes in the BNF click on changes.

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