Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension pack size discrepancy

CONTENT EXPIRED: See Changes to Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension pack sizes

Community Pharmacy England has become aware of a discrepancy in the pack size listings for Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension. This suspension is currently marketed in 100ml and 250ml pack sizes by Bayer Plc. However, these volumes represent the actual bottle sizes and not the final reconstituted volumes of the product.

Normally, for oral liquids requiring reconstitution, the pack sizes listed in the Drug Tariff and/or the NHS dictionary of medicines and devices (dm+d) are based on the final reconstituted volume rather than the bottle size. However, the pack sizes for Xarelto oral suspension have not been authored accordingly.

The 100ml pack size, requires the addition of 50ml of water to give a final concentration of 1 mg/ml rivaroxaban oral suspension. The 250ml pack size requires the addition of 100ml of water to achieve the same strength. However, once the water is added to the granules, the exact volume of oral solution in the bottle after reconstitution can actually be slightly more than the 50ml and 100ml, respectively. This creates confusion for prescribers, dispensers and patients as the quantity prescribed may not always correspond to the quantity dispensed. Owing to these discrepancies in pack size listings, pharmacy owners should be aware that reimbursement for Xarelto suspension is currently based on the bottle size and not the final reconstituted volume as follows:

250ml pack size – licensed for children weighing 4 kg and more

• If a 250ml pack size is ordered (which provides approximately 100ml of the final reconstituted volume), pharmacies are only reimbursed for 1 x 250ml pack size.
• If a prescriber intended for the patient to receive 250ml of the final reconstituted medicine, the prescription will need to be amended to request 3 x 250ml packs to provide approximately 300mls of the actual usable volume (complete packs are to be supplied as this product is classed as a special container).

100ml pack size – licensed for children weighing less than 4 kg

• If a 100ml pack size is ordered (which provides approximately 50ml of the final reconstituted volume), pharmacies are only reimbursed for 1 x 100ml pack size.
• If a prescriber intended for the patient to receive 100ml of the final reconstituted medicine, the prescription will need to be amended to request 2 x 100ml packs to provide approximately 200mls of the actual usable volume (complete packs to be supplied as this product is classed as a special container).

Note: As the two available pack sizes are licensed for different age groups, pharmacy teams should not supply a combination of pack sizes to fulfil the quantity ordered.

Where there is ambiguity over the intended quantity to dispense. Community Pharmacy England advises pharmacy teams to seek clarity from the prescriber and request amendments to prescriptions, where appropriate.

We have raised these pack size listing issues with DHSC/NHSBSA and Bayer Plc who are working to determine the final reconstituted volumes for both pack sizes so these can be accurately reflected in the SmPCs, the Drug Tariff and dm+d.

We will keep you posted on any further developments.

FAQs

Q. I have received a prescription ordering 1 x 250ml Xarelto® 1mg/ml granules for oral suspension for use by a patient weighing >4kg. The prescriber has confirmed that they wish for the patient to receive 250ml of reconstituted oral suspension but the 250ml pack size only provides approximately 100ml of usable medicine following reconstitution. Will I be paid for supplying 3 x 250ml packs as this will provide 300ml of the usable medicine?

A. No. If a prescriber’s intention is for the patient to receive 250ml of the final reconstituted medicine, the prescription will need to be amended to request 3 x 250ml packs to provide approximately 300mls of the actual usable volume. Please note: complete packs are to be supplied as this product is classed as a special container. If a prescription requests 250ml, the pharmacy will only be reimbursed for 1 x 250ml pack size containing approximately 100ml of usable volume.

Q. Can I supply 2x250ml and 1x100ml bottles of Xarelto® 1mg/ml granules for oral suspension to provide 250ml of reconstituted oral suspension?

No. The 100ml pack size (licensed for children weighing <4kg) delivers approximately 50ml of usable volume whereas the 250ml pack size (licensed for children weighing >4kg) delivers approximately 100ml of usable volume. As the two available pack sizes are licensed for different age groups, pharmacy teams should not supply a combination of pack sizes to fulfil the quantity ordered. If the prescriber’s intention is for the patient to receive 250ml of the final reconstituted medicine, the prescription will need to be amended to request 3 x 250ml packs to provide 300mls of the actual usable volume (complete packs are to be supplied as this product is classed as a special container). Please note that the 100ml pack size is generally used in secondary care settings.