Summary

• XARELTO is indicated for treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.¹
• XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.¹
• XARELTO for oral suspension is supplied as white to off-white granules in an amber glass bottle containing 155 mg rivaroxaban packaged with two oral dosing syringes. After reconstitution with 150 mL of purified water, 1 mL of the suspension contains 1 mg rivaroxaban.¹
• To prepare the XARELTO oral suspension, tap the bottle until all granules flow freely. Add 150 mL of water for reconstitution. Shake for 60 seconds. Check that all granules are wetted and the suspension is uniform. Push the adaptor into bottleneck and recap bottle.¹

PRODUCT LABELING

Preparation Instructions for Pharmacy of XARELTO for Oral Suspension

Do not add flavor as product is already flavored (sweet and creamy).¹

Reconstitute before dispensing¹:

• Tap the bottle until all granules flow freely.
• Add 150 mL of purified water for reconstitution.
• Shake for 60 seconds. Check that all granules are wetted and the suspension is uniform.
• Push the adaptor into bottleneck and recap bottle.
• The suspension must be used within 60 days.
• Write the “Discard after” date on the bottle and carton.

Dispensing Instructions¹:

• Dispense in the original bottle.
• Dispense the bottle upright with the syringes provided in the original carton.

Store reconstituted suspension at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.¹

It is recommended the pharmacist counsel the caregiver on proper use. Alert the patient or caregiver to read the Medication Guide and Instructions for Use.¹

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 28 October 2024.