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Memo – shortage of supply
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Re: Tranexamic acid tablets 500mg (all brands)
Description of product affected
Tranexamic acid is a lysine analogue which can reversibly bind both circulating and fibrin-bound plasminogen and thus inhibit fibrinolysis.1 The tablets are licensed for short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis as occurs in the following conditions2
· Prostatectomy and bladder surgery
· Menorrhagia
· Epistaxis
· Conisation of the cervix
· Traumatic hyphaema
· Hereditary angioneurotic oedema
· Management of dental extraction in haemophiliacs
Background
There are currently limited supplies of generic tranexamic acid 500mg tablets on the market. This is due to difficulty in manufacturers obtaining raw material. Branded Tranexamic Acid 500mg (Cyklokapron), over the counter product (Cyklo-f)3 and some generic tranexamic acid 500mg tablets continue to be remain available, however there may be intermittent supplies issues until at least 2018.
Alternative agents and management options
Tranexamic acid injection can be administered orally (off-label use)4-6 and is an option in the acute setting, though it may not be particularly palatable.4
The main use of tranexamic acid is the treatment of heavy menstrual bleeding (HMB), which has been shown to reduce menstrual blood loss by up to 58%.7 Other non-hormonal treatment options recommended in the NICE guideline on HMB include NSAIDs in patients with no fibroids or fibroids less than 3 cm in diameter.8 CKS guidance suggests that if an NSAID is to be used, mefenamic acid, naproxen, or ibuprofen should be prescribed.9 NSAIDs have been shown to reduce blood loss by 20-50%7 but mefenamic acid is the only one licensed for treating menorrhagia.7,10 It is claimed to be the most effective choice of NSAID because it has a dual action, reducing prostaglandin synthesis and inhibiting prostaglandin E2 to its receptor. Ibuprofen and naproxen are licensed for use in dysmenorrhoea but not menorrhagia, but each has been shown to reduce blood loss. The adverse effect profile of NSAIDs need to be taken into account when prescribing NSAIDS though the population with menorrhagia will be predominantly young and use would only be on an intermittent basis.7 Suitability of an NSAID should be assessed, taking into account cautions and contraindications to their use; and specialists consulted for alternative treatment options such as hormonal therapies if NSAIDs are not considered suitable.9
In patients with inherited bleeding disorders tranexamic acid is especially helpful in reducing mucosal bleeding where fibrinolytic activity is particularly active. It can be administered orally, intravenously or topically (as a mouth wash). It is often given as an adjunct to desmopressin in treatment of oral bleeding, menorrhagia or prophylaxis for dental surgery.1
Points for consideration
There are certain groups of patient for whom there are no other treatment options and existing stock should be prioritised for their use until the shortage situation resolves. These include anticoagulated patients with menorrhagia who are not suitable for NSAIDs, patients with inherited bleeding disorders, postnatal patients. Other niche uses will need to be addressed on a case by case basis. In the acute setting, off label use of the injection for oral administration may be considered. Haematologists should be consulted for further advice on treatment options.
References
1. Keeling, D, et al. Guideline on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. Haemophilia 2008; 14: 671–684: http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2516.2008.01695.x/full
2. Meda Pharmaceuticals. Cyklokapron Tablets. SPC, date of revision of text September 2016: http://www.medicines.org.uk/emc/medicine/16512
3. Meda Pharmaceuticals. Cyklo-f 500mg film coated tablets. SPC, date of revision of text, September 2016: https://www.medicines.org.uk/emc/medicine/27753
4. Evelina London Paediatric formulary accessed online 25 Aug 2017: http://cms.ubqo.com/public/d2595446-ce3c-47ff-9dcc-63167d9f4b80/content/1e393f73-b240-49aa-abd5-96ca2c744b39
5. The NEWT Guidelines. Tranexamic acid. Monograph updated November 2015
6. Handbook of Drug Administration via Enteral Feeding Tubes accessed online 25 Aug 2017 via medicinescomplete.com
7. Haynes S. Menorrhagia and its management. Pharm J 2011; 286: 71-74: http://www.pharmaceutical-journal.com/files/rps-pjonline/pdf/pj20110122_cpd.pdf
8. NICE. Heavy menstrual bleeding: assessment and management Clinical guideline [CG44] Published: January 2007, last updated: August 2016: https://www.nice.org.uk/guidance/cg44/chapter/Recommendations#pharmaceutical-treatments-for-hmb
9. NICE. Menorrhagia. CKS, last revised August 2015: https://cks.nice.org.uk/menorrhagia#!scenario
10. Chemidex Pharma Ltd. Ponstan Capsules 250mg. SPC, date of revision of text 07/12/2015: http://www.medicines.org.uk/emc/medicine/8585
Acknowledgements
Jane Bass, Senior Pharmacist, Women's Services, Ursula Gotel, Highly Specialist Pharmacist-Acute Medicine, Anya Vlassoff Senior Pharmacist-Patient Services, Dr Simon Anderson, Gastroenterologist, and Prof Beverley Hunt, Haematologist; Guy's and St Thomas' NHS Foundation Trust
Original document prepared by:
Yuet Wan, London and South East Regional Medicines Information, Guy’s and St Thomas’ NHS Foundation Trust (25 Aug 2017)
Document modified by:
Name of individual at other centre using the product with modifications, centre, date
For all correspondence please contact:
Name of person at base hospital where memo is circulated (i.e. NOT the original author at Guy’s and St Thomas’ NHS Foundation Trust
Disclaimer: The content of some of this memo is based on clinical opinion from practitioners. Users should bear this in mind in deciding whether to base their policy on this document. Individual trusts should ensure that procedures for unlicensed medicines are followed where a foreign import drug is required in the interim.