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Newsletter
October 2019

Welcome to the October BNF Newsletter.

• Five new drug monographs have been added to the BNF in the last month: andexanet alfa, cemiplimab, galcanezumab, lamivudine with dolutegravir, and patisiran.
• We have included dose changes for vitamin B substances with ascorbic acid to the BNF.
• We have also included MHRA advice on carfilzomib (Kyprolis®), daratumumab (Darzalex®), naltrexone with bupropion (Mysimba®), and pentosan polysulfate sodium (Elmiron®) to the BNF.

Kind regards,
BNF Team

Other topics:

Significant changes   |   Drug safety update   |   News   |   Feedback

Significant changes

BNF BNF only

New monograph: Ondexxya® [andexanet alfa] for reversal of apixaban or rivaroxaban in life-threatening or uncontrolled bleeding (specialist supervision in hospital).

New monograph: Libtayo® [cemiplimab] for cutaneous squamous cell carcinoma (specialist use only).

New monograph: Emgality® [galcanezumab] for prophylaxis of migraine [in patients who have at least 4 migraine days per month] (initiated by a specialist).

New monograph: Dovato® [lamivudine with dolutegravir] for HIV-1 infection.

New monograph: Onpattro® [patisiran] for stage 1 or stage 2 polyneuropathy in patients with hereditary transthyretin amyloidosis (hATTR) (initiated under specialist supervision).

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].

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].

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].

Vedolizumab for treating moderately to severely active ulcerative colitis [NICE guidance].

Hyperparathyroidism: new guidance on management of primary hyperparathyroidism.

Prostate Cancer: updated guidance on management.

Dose Changes for BNF only
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 for Children BNFC Only

Depression: updated guidance management.

BNF BNF for Children Both BNF and BNFC

Ulcerative colitis: updated guidance on management.

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

 
Drug Safety Update
 

Drug Safety Update is a monthly newsletter from the MHRA and Commission on Human Medicine. Please follow this link to review the latest Drug Safety Update.

Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy.

Fingolimod (Gilenya): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception.

Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping.

Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions.

 
 

News

 

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