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4 September 2023

Fluticasone Nasal Drops Supply Update

26 July 2024

As per the bulletin on 11th January, following the decision of GSK to cease production of, and supply to, the UK market of Flixonase® Nasule drops (Fluticasone propionate), Aspire Pharma have available generic Fluticasone propionate 400mcg (1mg/ml) nasal drops, suspension x 30.  Aspire have confirmed they have unrestricted stock available, ready to be prescribed to those patients who are suitable and had previously been receiving the GSK product.

Indicated for the regular treatment of nasal polyps and associated symptoms of nasal obstruction, in adolescents and adults over 16 years of age, the product is available in packs of 30 single-dose containers, each containing 400mcg of fluticasone propionate, equating to 1mg/ml and is priced at £15.99 1. Consult the SmPC or Prescribing Information for Special warnings and precautions for use.  

NICE recommends topical corticosteroids (eg. fluticasone) for nasal polyps, and The British Society of Allergy and Clinical Immunology (BSACI) recommends fluticasone specifically for long-term maintenance therapy of nasal polyps due to its lower bioavailability3.

As part of Aspire Pharma’s commitment to work in partnership with the NHS and consistently offer a reliable supply chain, Fluticasone propionate 1mg/ml (400mcg) Nasal drops, suspension x 30 are stocked by each of the mainline wholesalers listed below. This means pharmacies can obtain products via their usual delivery schedules.

  • Alliance
  • AAH
  • Mawdsley Brooks
  • Phoenix

11 January 2024

We have been informed by the UK company  Aspire Pharma that their generic version of  Fixonase Nasules 400mcg  is now available but in limited supply. They expect to be able to increase availability to meet demand during the first half of 2024.

Aspire Pharma will be posting updates on their website.

Cessation of Flixonase nasule drop production in the UK:

BRS guidelines and recommendations for alternative nasal steroid spray and drop medications in the treatment of chronic rhinosinusitis in adults

UK production of Flixonase Nasule Drops (Fluticasone propionate 400mcg) by Glaxosmithkline (GSK) will cease from December 2023 and availability in the preceding months may be limited. GSK have been the sole producers of Flixonase nasules, which are an important treatment for chronic rhinosinusitis in primary and secondary care. In severe cases of CRS, Flixonase Nasules may be prescribed long-term instead of nasal sprays in an attempt to reduce the need for surgical intervention or rescue medication (e.g. oral steroids). Future production of Flixonase Nasule alternatives by other suppliers will be available soon however there maybe potential supply and demand limitations during the initial roll out.

The BRS has produced guidelines for alternative nasal steroid use, focusing on safety (adverse effects) and ‘off licence’ use.

  1. Corticosteroid irrigation (CSI)

Corticosteroid irrigation has been commonly used within the UK following endoscopic sinus surgery for severe CRS. Pulmicort respules (budesonide 250 or 500mcg/2ml) dissolved into a 240ml saline rinse solution can be used up to twice a day. There is no evidence of adrenal suppression, (1) however caution should be considered in patients on high doses of pulmonary steroids due to the risk of adverse effects. (2) BRS recommends CSI, based on treatment recommendations from the International Consensus Statement on Allergy and Rhinitis 2021 (ICAR). (1) However, CSI using Pulmicort respules remains ‘off licence’ for nasal use. Owing to ‘off licence’ use as well as increased cost, local NHS trust and pharmacy approval may be required. There could be variance in local prescribing guidelines with the potential of limited access.

  1. Intranasal corticosteroid (INCS) sprays

Intranasal corticosteroid sprays are recommended as per the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS 2020) (3) and ICAR (1) guidelines. There is minimal systemic absorption with the newer generation of INCS sprays such as fluticasone or mometasone which should be used up to the maximum licenced dose as per the BNF. Caution should be considered with regards to doubling-up on the maximum licensed dose for the newer generation of INCS sprays owing to the lack of consensus on ‘treatment recommendations’ as well as being ‘off license’.

  1. Betnesol Nasal Drops

Betnesol Nasal Drops 0.1% w/v (betamethasone) can be used as a rescue medication at a dose of 2 drops 2-3 times per day as per BNF guidelines, (4) and duration of treatment should not exceed 6 weeks. (5) Dosage of droplets remains non-metered, unlike with spray applications and therefore caution should be considered due to the risk of systemic absorption and adverse effects which need to be considered. These include HPA axis suppression and raised intraocular pressure. Once rescue medication has completed, a step down to INCS sprays are recommended.

References

  1. Orlandi R, Kingdom T, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. Int Forum Allergy Rhinol . 2021 Mar;11(3):213-739. doi: 10.1002/alr.22741.
  2. Soudry E, Wang J, Vaezeafshar R, Katznelson L, Hwang PH. Safety analysis of long-term budesonide nasal irrigations inpatients with chronic rhinosinusitis post endoscopic sinussurgery.Int Forum Allergy Rhinol. 2016;6(6):568-572
  3. Fokkens W, Lund V et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
  4. British National Formulary (2023). https://bnf.nice.org.uk/drugs/betamethasone/
  5. Electronic Medicines Compendium (2023) (https://www.medicines.org.uk/emc/product/10814/smpc#about-medicine)

 

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