XARELTO® is the only FDA-approved antithrombotic treatment to offer pediatric patients both an oral suspension and tablets1,2
NO injections*
NO INR monitoring required
NO special diet required†
The oral-suspension formulation is administered through a color-coded device to help with dosing and administration
Pediatric dosing of XARELTO® is based on the child’s weight1
Recommended dosage in pediatric patients from birth to <18 years of age for treatment of VTE and reduction in risk of recurrent VTE*†
Administration in pediatric patients1
For the treatment of VTE in children, the dose should be taken with food to increase absorption.
If the patient vomits or spits up the dose within 30 minutes after receiving the dose, a new dose should be given. However, if the patient vomits >30 minutes after the dose is taken, the dose should not be readministered and the next dose should be taken as scheduled. If the patient vomits or spits up the dose repeatedly, the caregiver should contact the child’s doctor right away.
- Tablets:
- XARELTO® tablet must not be split in an attempt to provide a fraction of a tablet dose
- For children unable to swallow 10-mg, 15-mg, or 20-mg tablets whole, XARELTO® oral suspension should be used
- XARELTO® 2.5-mg tablets are not recommended for use in pediatric patients
- In Children <6 Months of Age:
Dosing of XARELTO® was not studied and therefore dosing cannot be reliably determined in the following patient populations.
Its use is therefore not recommended in children less than 6 months of age with any of the following:
- Less than 37 weeks of gestation at birth
- Less than 10 days of oral feeding
- Body weight of less than 2.6 kg
Monitor the child’s weight and review the dose regularly, especially for children below 12 kg. This is to ensure a therapeutic dose is maintained.
Please see the “Instructions for Use” in Prescribing Information for directions on using the oral-suspension formulation.
Additional Administration Considerations
Use in renal impairment in pediatric patients:
PATIENTS 1 YEAR OF AGE OR OLDER:
- Mild renal impairment (eGFR: 50 to ≤80 mL/min/1.73 m2 ): no dose adjustment is required.
- Moderate or severe renal impairment (eGFR: <50 mL/min/1.73 m2 ): avoid use, as limited clinical data are available.
- eGFR can be done using the updated Schwartz formula, eGFR (Schwartz) = (0.413 x height in cm)/SCr in mg/dL, if SCr is measured by an enzymatic creatinine method that has been calibrated to be traceable to IDMS.
- If SCr is measured with routine methods that have not been recalibrated to be traceable to IDMS (eg, the traditional Jaffé reaction), the eGFR should be obtained from the original Schwartz formula: eGFR (mL/min/1.73 m2) = k * height (cm)/SCr (mg/dL), where k is proportionality constant:
- k = 0.55 in children 1 year to 13 years
- k = 0.55 in girls >13 and <18 years
- k = 0.70 in boys >13 and <18 years
PATIENTS <1 YEAR OF AGE:
Determine renal function using serum creatinine. Avoid use of XARELTO® in pediatric patients younger than 1 year with serum creatinine results above 97.5th percentile, as no clinical data are available.
Reference values of serum creatinine in pediatric patients <1 year of age
Pharmacokinetic Considerations:
- The half-life of rivaroxaban in plasma of pediatric patients treated for VTE decreased with decreasing age
- Mean half-life values were 4.2 hours in adolescents, 3 hours in children 2 to 12 years of age, 1.9 hours in children 0.5 to <2 years of age, and 1.6 hours in children <0.5 years of age
- An exploratory analysis in pediatric patients treated for VTE did not reveal relevant differences in rivaroxaban exposure based on gender
Switching to and from XARELTO®
From warfarin to XARELTO® - When switching patients from warfarin to XARELTO®, discontinue warfarin and start XARELTO® as soon as the INR is below 2.5 in pediatric patients to avoid periods of inadequate anticoagulation.
From XARELTO® to warfarin - To ensure adequate anticoagulation during the transition from XARELTO® to warfarin, continue XARELTO® for ≥2 days after the first dose of warfarin. After 2 days of coadministration, an INR should be obtained prior to the next scheduled dose of XARELTO®. Coadministration of XARELTO® and warfarin is advised to continue until the INR is ≥2.0.
Once XARELTO® is discontinued, INR testing may be done reliably 24 hours after the last dose.
From XARELTO® to anticoagulants other than warfarin - For pediatric patients currently taking XARELTO® and transitioning to an anticoagulant with rapid onset, discontinue XARELTO® and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next XARELTO® dose would have been taken.
From anticoagulants other than warfarin to XARELTO® - For pediatric patients currently receiving an anticoagulant other than warfarin, start XARELTO® 0 to 2 hours prior to the next scheduled administration of the drug (eg, LMWH or non-warfarin oral anticoagulant) and omit administration of the other anticoagulant. For UFH being administered by continuous infusion, stop the infusion and start XARELTO® at the same time.
Missed dose
- If XARELTO® is taken once a day, the patient should take the missed dose as soon as possible once it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed. The patient should not take two doses to make up for a missed dose
- If XARELTO® is taken 2 times a day, the patient should take the missed morning dose as soon as possible once it is noticed. A missed morning dose may be taken together with the evening dose. A missed evening dose can only be taken in the same evening
- If XARELTO® is taken 3 times a day, if a dose is missed, the patient should skip the missed dose and go back to the regular dosing schedule at the usual time without compensating for the missed dose
On the following day, the patient should continue with their regular regimen.
Administration options
Administration of XARELTO® suspension via NG tube or gastric feeding tube: XARELTO® oral suspension may be given through NG or gastric feeding tube. After the administration, flush the feeding tube with water.
For the treatment or reduction in risk of recurrent VTE in pediatric patients, the dose should then be immediately followed by enteral feeding to increase absorption.
An in vitro compatibility study indicated that XARELTO® oral suspension can be used with PVC, polyurethane or silicone NG tubing.