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Recent updates from the BNF (BNF 85)
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Abstract

The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some of the key changes that have been made to BNF content.

  • Health Care Quality, Access, and Evaluation
  • Drug-Related Side Effects and Adverse Reactions

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The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some of the key changes that have been made to BNF content since the last print edition (BNF 84) was published.

New drug monographs

Trifarotene (▼Aklief)

This topical retinoid cream is used for the treatment of acne vulgaris.

Drospirenone with estetrol (▼Drovelis)

A 28-day monophasic oral hormonal contraceptive containing a new oestrogen, estetrol, with the progestogen drospirenone. Estetrol is a naturally occurring oestrogen, normally produced by the human fetal liver during pregnancy.

Finerenone (▼Kerendia)

Finerenone is a non-steroidal mineralocorticoid receptor antagonist indicated for chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes. It reduces the inflammation and fibrosis that lead to kidney damage, by inhibiting receptor-mediated sodium reabsorption and decreasing receptor overactivation.

Magnesium citrate

An oral supplement in tablet form that can be used as an alternative to magnesium glycerophosphate and magnesium aspartate, for the treatment and prevention of magnesium deficiency.

Netilmicin (Nettacin)

Applied as an eye drop, this semi-synthetic, broad-spectrum aminoglycoside antibiotic is used for the topical treatment of eye infections.

Potassium citrate with potassium bicarbonate (Sibnayal)

This combination is formulated as prolonged-release granules that are taken orally for the treatment of distal renal tubular acidosis

Rimegepant (▼Vydura)

A calcitonin gene-related peptide receptor antagonist in oral lyophilisate form, rimegepant is used for the prophylaxis and treatment of migraine.

Updated monographs or dose changes

Tacrolimus

Pregnancy advice for systemic tacrolimus has been updated to include maternal risks, as well as further risks to the fetus. Advice for topical tacrolimus has been updated using specialist sources indicating that it can be considered for use during pregnancy if benefit outweighs potential risk, however, there is limited information available. Breast-feeding advice has also been updated using specialist sources which indicate that the amount of drug present in breast milk is probably too small to be harmful, however, exclusively breastfed infants should be monitored if there are concerns about toxicity. Advice for systemic use has also been updated to include monitoring for posterior reversible encephalopathy syndrome, and that patients of black African or African-Caribbean family origin may require higher doses adjusted according to whole-blood tacrolimus trough concentration.

Valaciclovir

This monograph has been updated to include indication and doses in line with UK Health Security Agency recommendations on post-exposure prophylaxis for chickenpox and shingles.1 Dosing for this indication is unlicensed.

Important safety updates

Metformin hydrochloride

A European review, with input from the Medicines and Healthcare products Regulatory Agency (MHRA), has found vitamin B12 deficiency to be a common adverse effect in patients treated with metformin.2 Patients and their carers should be counselled on the signs and symptoms of vitamin B12 deficiency. Healthcare professionals are advised to check serum-vitamin B12 levels if deficiency is suspected, consider periodic monitoring in patients with risk factors for deficiency, and treat deficiency according to current guidelines. Treatment with metformin should be continued for as long as it is tolerated.

Methylphenidate hydrochloride

The MHRA has advised caution when switching between long-acting preparations of methylphenidate, due to differences in dosing frequency, administration with food, amount and timing of the modified-release component, and overall clinical effect.3

Healthcare professionals are advised to follow the specific dosage recommendations for each preparation, discuss the reasons for switching with patients or their carers, and provide counselling on administration, especially with regards to food.3 Current clinical guidance should be followed on prescribing by brand name, or by manufacturer name if generic, and frequent switching between different preparations should be avoided.

Nebulised asthma rescue therapy in children

The MHRA has reviewed the evidence regarding a number of deaths in children with asthma, where the clinically unsupervised use of a nebuliser to deliver asthma rescue medication was a potential contributory factor.4

Healthcare professionals are advised that home use of nebulisers for the acute treatment of asthma in children and adolescents should only be initiated and managed by asthma specialists.4 Without adequate medical supervision, home nebulisers can mask a deterioration in the underlying disease, which could result in delays in seeking medical attention and be fatal or have serious consequences.

Patients and their carers should be advised to seek urgent medical attention if worsening asthma symptoms are not relieved by prescribed rescue medication, even if there is short-term recovery following its use.4 They should receive training from a healthcare professional on the usage and maintenance of the nebuliser, and be given advice on when to seek medical attention, so that deterioration in asthma control can be treated without delay. Patients (or their carers) who have been using a nebuliser at home without specialist management should contact their GP about referral to a specialist.

Topiramate (Topamax)

The MHRA has started a new safety review of topiramate following a large observational study that found a dose-dependent association between prenatal exposure and an increased risk of autism spectrum disorders, intellectual disability, and neurodevelopmental disorders in children.5 Topiramate must be prescribed according to current guidance. Females of childbearing potential, or their carers, should be counselled on the importance of avoiding pregnancy due to the emerging and established risks associated with topiramate use in pregnancy.

Report any suspected adverse reactions via the Yellow Card Scheme. Further information on reporting of adverse reactions to drugs and the Yellow Card Scheme can be found on MedicinesComplete and in BNF print versions and on the Yellow Card Scheme website (https://yellowcard.mhra.gov.uk).

Updated treatment summaries

Depression

The management of depression has been updated in line with the National Institute for Health and Care Excellence (NICE) guideline based on classifications of subthreshold or mild depression, and moderate or severe depression.6 This overview includes drug treatments as well as psychological and psychosocial options, and considerations in the management of depression during pregnancy and breast-feeding.

Gout

This treatment summary has been updated in-line with new NICE guidance to recommend a short course of oral corticosteroids as a first-line treatment option for an acute attack of gout, and includes target serum urate levels for the long-term control of gout.7

Herpesvirus infections

This treatment summary has been updated to include guidance from the UK Health Security Agency on the unlicensed use of aciclovir and valaciclovir for post-exposure prophylaxis of varicella infection, to reduce the risk of complications in individuals at increased risk of severe infection.1

Hypertension

This treatment summary has been updated in-line with NICE guidance to include blood pressure targets based on urine albumin:creatinine ratio for patients with type one diabetes.8

Type 1 diabetes

This treatment summary has been updated to include the NICE recommendation of continuous glucose monitoring to support patients to self-manage their diabetes.8

Type 2 diabetes

Recommendations for the use of non-insulin antidiabetic drugs has been updated in-line with NICE guidance.9 Metformin is now recommended alongside a sodium-glucose co-transporter 2 (SGLT2) inhibitor with proven cardiovascular benefit as first-line treatment for patients with chronic heart failure or established atherosclerotic cardiovascular disease, or who are at high risk of developing cardiovascular disease. If metformin is contra-indicated or not tolerated in these patients, an SGLT2 inhibitor with proven cardiovascular benefit is now also recommended first-line as alternative initial treatment. In addition, guidance for the use of specific SGLT2 inhibitors as part of triple therapy has been updated.

BNF Editorial Team

For further information see the BNF, available on MedicinesComplete (https://about.medicinescomplete.com), BNF app for IOS and android, and BNF 85 print edition.

References