Available products

Fungizone

Fungizone 50mg powder for sterile concentrate is the originator product and the only conventional formulation of amphotericin B available.

Gilead Liposomal

Amphotericin B Gilead Liposomal 50mg powder for dispersion for infusion is the originator liposomal amphotericin, and was previously known as AmBisome. It contains 50mg of the active substance amphotericin B (50,000 units) encapsulated in liposomes.

Both AmBisome branded and non-branded products may exist in the NHS supply chain in early 2025.

Tillomed Liposomal

Amphotericin B Tillomed Liposomal 50mg powder for dispersion for infusion is a generic liposomal amphotericin B product. It contains 50mg of the active substance amphotericin B (50,000 units) encapsulated in liposomes.

Safety with conventional and liposomal products

Do not use conventional in place of liposomal

You must not use conventional amphotericin in place of liposomal amphotericin.

The products are not interchangeable since they have significant differences in their pharmacokinetics and dosing. The conventional formulation is more nephrotoxic than the liposomal formulation. Patient harm, including fatality, has been reported following inadvertent administration of conventional amphotericin B infusion instead of an intended liposomal formulation.

Mitigate to prevent confusion

Put measures in place to minimise the potential for accidentally selecting the wrong product. Review these measures regularly.

Prescribe using the proprietary name

When prescribing, the MHRA recommends using the proprietary or brand name together with the common name and specifically including “liposomal” in the prescription.

Nomenclature

Use consistent nomenclature in clinical guidelines and protocols, in prescribing systems, and in pharmacy stock control systems.

Electronic systems

Set up electronic prescribing, dispensing and supply systems to support users in choosing the correct product.

Stockholding

Review and rationalise stockholding to minimise the potential for selecting the wrong product. Where more than one product is stocked, such as in hospital pharmacies, minimise selection errors by using separate locations and visual alerts.

Promote awareness

Ensure healthcare professionals responsible for prescribing, supply, and administration are aware of the availability of different amphotericin B injection formulations and the risks associated with selecting the wrong product.

Utilise aseptic services

Where possible, use products prepared by aseptic services.

Interchangeability between liposomal products

Liposomal amphotericin B products are interchangeable

Amphotericin B Gilead Liposomal (previously AmBisome) and Amphotericin B Tillomed Liposomal are interchangeable.

They are bioequivalent and have the same clinical efficacy and safety profiles. This is based on the MHRA’s evaluation of qualitative and quantitative sameness, manufacturing process, physico-chemical comparison, different characterisation studies, non-clinical studies and human pharmacokinetic study.

There is also no difference between the two in their indication, contraindications, special warnings and precautions, recommended monitoring, drug interactions or adverse effects.

Minor differences in shelf lives of the products

The Summaries of Medicinal Product Characteristics for Amphotericin B Gilead Liposomal and Amphotericin B Tillomed Liposomal are identical with the exception of differences between the shelf lives of the products:

• Amphotericin B Gilead Liposomal has a shelf live of 4 years
• Amphotericin B Tillomed Liposomal has a shelf life of 3 years

The SmPCs also detail some minor differences in shelf life after dilution with dextrose solutions. Refer to the specific SmPC for the product being used.

Monitoring Expenditure

You can monitor your organisation’s performance in switching to best-value liposomal amphotericin B via our Key Molecules Expenditure tool. Access to this tool is for approved subscribers and you should liaise with your regional pharmacy procurement team to gain access.

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