Clinical use

Fidaxomicin is used for treating Clostridioides difficile (C. difficile) infection. See the NICE guideline on antimicrobial prescribing in Clostridioides difficile infection and local guidance for specific recommendations on its place in treatment.

Avoiding delayed or omitted doses

Local guidance on how to order, prepare and administer each chosen formulary option, including when pharmacy services are unavailable, will help reduce the risk of delayed or omitted doses.

Choosing suitable formulary options

This article aims to support local decision-making when choosing which fidaxomicin formulations to include on a formulary. It highlights key considerations and suggests risk mitigations to support formulary decisions. It is not intended to guide clinical decisions regarding the most appropriate formulation for individuals.

The options discussed are not presented in order of preference and may not be exhaustive.

Local formulary choices may depend on:

• national and local guidance
• licensing status of each formulation
• local access to each formulation
• the patient population and the care setting.

Formulary options for swallowing difficulties

Formularies should include oral options for people who cannot safely swallow tablets. This reduces risk of aspiration or choking and doses being delayed or omitted due to prescribing of inappropriate formulations.

Oral liquid formulations may be suitable formulary options for people who are not able to safely swallow tablets, but only if they are able to safely swallow thin liquids. For people unable to safely swallow thin liquids, crushing tablets and giving them with food or fluid that the person can swallow safely is more appropriate.

Specific advice on the most appropriate formulation for an individual depends on the food and fluid they can safely swallow. A swallow assessment report from a speech and language therapist is needed for individuals who cannot safely swallow food and fluid.

The SPS guidance on swallowing difficulties gives advice on using medicines safely and effectively in people with swallowing difficulties. This advice may be helpful for developing local guidance to support safe use of chosen formulary options.

Licensed tablets

Fidaxomicin tablets are only suitable for people who can safely swallow them. Additional formulary options are needed for people who cannot safely swallow tablets. These are described below.

Licensed oral suspension

Fidaxomicin oral suspension is supplied as granules to be reconstituted before use. It requires refrigeration once reconstituted and may not be routinely stocked in many clinical areas, leading to delayed or omitted doses. It may also be stored inappropriately, leading to wastage.

These risks can be reduced by:

• reviewing stock and supply processes to ensure the oral suspension can be obtained without delay
• ensuring clear refrigerator labelling and communication for staff and patients
• providing local guidance for how to order the oral suspension, including when pharmacy services are not available.

Oral administration

Fidaxomicin oral suspension may be a suitable formulary option for people who are not able to safely swallow tablets, but only if they are able to safely swallow thin liquids.

Thickening of the suspension is not recommended for people who cannot safely swallow thin liquids. This is because it is not possible to assess if the liquid has been thickened to an appropriate thickness for that individual. In these cases, an additional formulary option to allow for crushing tablets is needed.

Enteral feeding tubes

Fidaxomicin oral suspension is licensed for administration via an enteral feeding tube.

Enteral feeding tubes made of polyvinylchloride (PVC) and polyurethane (PUR) are compatible with the oral suspension. The recommended enteral feeding tube size and flush volume of water are available in the summary of product characteristics for fidaxomicin granules for oral suspension. This information may be helpful to include in local guidance to support clinical staff with administration, which will help reduce the risk of delayed or omitted doses.

Crushing licensed tablets

Licensed fidaxomicin tablets can be crushed but this is an ‘off-label’ use.

This option may be needed for:

• individuals who cannot safely swallow tablets or thin liquids, for whom other options are not safe
• administration via an enteral feeding tube, but only if the licensed oral suspension is unavailable.

The SPS advice on how to crush or disperse tablets and open capsules and SPS advice on why and how medicines are given with soft food or thickened fluid may be helpful to include in local guidance.

Oral administration

Fidaxomicin tablets, crushed and mixed with water or food the person can swallow safely, may be appropriate for some individuals with swallowing difficulties (see the section above on formulary options for swallowing difficulties). There is a risk that the full dose may not be received if all the water or food that the tablets are mixed in is not consumed.

If this option is included on a formulary, guidance should be available for how to crush and administer the tablets. This should include ensuring that the whole tablet is administered, by:

• fully rinsing tablet crushers, medicine pots and oral syringes
• ensuring all the water or soft food in which the tablet has been mixed is consumed
• using a small amount of water or soft food to help ensure the full dose is taken.

Enteral feeding tubes

Fidaxomicin tablets may be crushed and mixed with water, then administered via an enteral feeding tube. However, there is limited data on this, so it is not recommended as a formulary option unless the oral suspension is unavailable.

The tablets are film-coated so may block enteral feeding tubes. If this option is included on a formulary, guidance should be available on:

• fully rinsing tablet crushers, medicine pots and oral syringes
• crushing the tablets well to avoid blocking the feeding tube
• flushing the tube well after administration to ensure that the entire dose is given.

Other oral treatment options for Clostridioides difficile

The SPS article on choosing between oral vancomycin options has advice to help local formulary and commissioning teams choose suitable oral vancomycin options.

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