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

From 1 April 2024, the pack size listings of Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension will be updated. This follows the identification by Community Pharmacy England of a discrepancy in the pack size listings for Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension. Currently, the pack sizes listed in the Drug Tariff and the NHS dictionary of medicines and devices (dm+d) represent the actual bottle sizes and not the final reconstituted volumes of the suspension after reconstitution.

As the final reconstituted volumes are not specified in the product SmPC and packaging for Xarelto® 1mg/ml granules for oral suspension, the dm+d Content Committee has agreed to change the dm+d pack size information to reflect to the actual volumes of water added for reconstitution rather than the bottle sizes – see table below.

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

Please note the exact volume of oral solution in the bottle after reconstitution can actually be slightly more than the 50ml and 100ml once reconstituted. The use of the term ‘volume of water added for reconstitution’ refers to the volume of water required to give a final concentration of Rivaroxaban 1mg/ ml and not the final volume of liquid in the bottle after reconstitution. Only the 250ml pack size (for children >4kg) is currently listed in the Drug Tariff and this will be updated to 100ml to reflect the volume of water added for reconstitution.

Due to the lag in updating of prescribing systems to reflect these changes, pharmacies may continue to receive prescriptions for the older pack sizes (bottle sizes). Until prescribing systems have updated and ‘mapped’ across new product codes (with updated pack sizes) by using the latest dm+d extract, pharmacy teams may need to seek clarity from the prescriber regarding the quantity required by the patient and request amendments to prescriptions, where appropriate. For example if a prescription specifies 250ml, this may be referring to the old pack size (bottle size) which contains approximately 100ml of the reconstituted volume of medicine. Alternatively, the prescriber may want the patient to actually receive 250ml of the reconstituted volume of the medicine – although this would mean supplying 2 x 100ml bottles because of special container rules or the prescriber should order 3 x100ml to ensure the patient receives the complete quantity.

Note: The two available pack sizes are licensed for different age groups. The 100ml pack size (previously 250ml bottle size) is licensed for children weighing 4 kg and more and the updated 50ml pack size (previously 100ml bottle size) is licensed for children weighing less than 4 kg.

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. Will I be paid for supplying 3 x 100ml packs?

A. No. Following special container rules prescriptions requesting 250ml will be rounded down to the nearest complete pack sizes and reimbursed as 2 x 100ml. 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 100ml packs.

Q. I have received a prescription ordering 1 x 250ml Xarelto® 1mg/ml granules for oral suspension and the prescriber has clarified that they wish for the patient to receive 100ml of reconstituted oral suspension. What will I be reimbursed for a prescription requesting 250ml?

A. If a quantity of 250ml is prescribed, the pharmacy owner will be reimbursed 2 x 100ml following special containers rules. If the pharmacy owner indicates that they have dispensed less, they would be reimbursed based on their dispensed quantity endorsement to the nearest quantity using the 100ml pack following special container rules.

Q. Can I supply a combination of 2 x 100ml and 1 x 50ml bottles of Xarelto® 1mg/ml granules for oral suspension to fulfil a prescription requesting 250 ml?

No. 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 (over 4kg) to receive 250ml of the final reconstituted medicine, the prescription will need to be amended to request 3 x 100ml 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 50ml pack size is normally used in secondary care settings for children weighing less than 4kg.