1.2. Pediatrics

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Apixaban and edoxaban are not recommended for use in pediatric patients, as the safety and efficacy have not been established for these agents in this patient population ^.1,2,5,6.

In June 2021, the FDA approved Pradaxa® (dabigatran) oral pellets to treat venous thromboembolism after receiving at least five days of injectable or intravenous treatment for blood clots and to reduce the risk of recurrent thromboembolism in patients 3 months to less than twelve years of age who have completed treatment for a previous venous thromboembolism⁹.

Dabigatran oral capsules were approved to treat venous thromboembolism after receiving at least five days of injectable or intravenous treatment for blood clots and to reduce the risk of recurrent thromboembolism in patients 8 years of age and older who have completed treatment for a previous venous thromboembolism⁹.

In December 2021, the FDA approved Xarelto® (rivaroxaban) tablets and oral suspension to treat venous thromboembolism and to reduce the risk of recurrent venous thromboembolism in patients less than 18 years of age who received at least five days of injectable or intravenous treatment for blood clots. Rivaroxaban was also approved to reduce the risk of blood clots in patients two years of age and older with congenital heart disease after the Fontan procedure¹⁰ .

Maximum recommended pediatric dosages for DOACs are summarized in Table 3 through Table 6. Medication profiles identifying patients prescribed dosages exceeding these recommendations will be reviewed.

Table 3. Maximum Daily Pediatric Dosages for DOACs in Pediatric Patients Less than 2 Years of Age: Direct Thrombin Inhibitors^1,2,4
Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
dabigatran (Pradaxa®) oral pellets!	20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg oral pellets	Treatment of VTE and to reduce the risk of VTE recurrence: 3 months to less than or equal to 2 years of age	Actual Weight: 3kg to less than 4kg^ 3 to less than 6 months: 30 mg twice daily Actual Weight: 4 kg to less than 5 kg^ 3 to less than 10 months: 40 mg twice daily Actual Weight: 5 kg to less than 7 kg^ 3 to less than 5 months: 40 mg twice daily 5 to less than 24 months: 50 mg twice daily Actual Weight: 7 kg to less than 9 kg^ 3 to less than4 months: 50 mg twice daily 4 to less than 9 months: 60 mg twice daily 9 to less than24 months: 70 mg twice daily Actual Weight: 9 kg to less than 11 kg^ 5 to less than 6 months: 60 mg twice daily 6 to less than 11 months: 80 mg twice daily 11 to less than 24 months: 90 mg twice daily Actual Weight: 11 kg to less than 13 kg^ 8 to less than 18 months: 100 mg twice daily 18 to less than 24 months: 110 mg twice daily Actual Weight: 13 kg to less than 16 kg^ 10 to less than 11 months: 100 mg twice daily 11 to less than 24 months: 140 mg twice daily Actual Weight: 16 kg to less than 21 kg^ 12 to less than 24 months: 140 mg twice daily Actual Weight: 21 kg to less than 26 kg*^ 18 to less than 24 months: 180 mg twice daily

Legend

VTE = venous thromboembolism
! Avoid dabigatran in patients with a CrCl less than 50 mL/min
* Requires at least 5 days of parenteral therapy before initiation of therapy for the treatment of VTE
^ Following appropriate treatment duration of DVT or PE treatment if used to reduce the risk of VTE recurrence

Table 4. Maximum Daily Pediatric Dosages for DOACs in Pediatric Patients 2 to Less than 12 Years of Age: Direct Thrombin Inhibitors^1,2,4
Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
dabigatran (Pradaxa®) oral pellets!	20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg oral pellets	Treatment of VTE and to reduce the risk of VTE recurrence: 2 to less than 12 years of age	Actual Weight: 7 kg to less than 9 kg^ 70 mg twice daily Actual Weight: 9 kg to less than 11 kg^ 90 mg twice daily Actual Weight: 11 kg to less than 13 kg^ 110 mg twice daily Actual Weight: 13 kg to less than 16 kg^ 140 mg twice daily Actual Weight: 16 kg to less than 21 kg^ 170 mg twice daily Actual Weight: 21 kg to less than 41 kg^ 220 mg twice daily Actual Weight: 41 kg or greater*^ 260 mg twice daily

Legend

VTE = venous thromboembolism
! Avoid dabigatran in patients with a CrCl less than 50 mL/min
* Requires at least 5 days of parenteral therapy before initiation of therapy for the treatment of VTE
^ Following appropriate treatment duration of DVT or PE treatment if used to reduce the risk of VTE recurrence

Table 5. Maximum Daily Pediatric Dosages for DOACs in Pediatric Patients 8 to Less than 18 Years of Age: Direct Thrombin Inhibitors^1-3
Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
dabigatran (Pradaxa®) capsules!	75 mg, 110 mg, 150 mg oral capsules	Treatment of VTE and to reduce the risk of VTE recurrence: 8 to less than 18 years of age	11 kg to less than 16 kg^ 75 mg twice daily 16 kg to less than 26 kg^ 110 mg twice daily 26 kg to less than 41 kg^ 150 mg twice daily 41 kg to less than 61 kg^ 185 mg twice daily 61 kg to less than 81 kg^ 220 mg twice daily 81 kg or greater^ 260 mg twice daily

Legend

VTE = venous thromboembolism
! Avoid dabigatran in patients with a CrCl less than 50 mL/min
* Requires at least 5 days of parenteral therapy before initiation of therapy for the treatment of VTE
^ Following appropriate treatment duration of DVT or PE treatment if used to reduce the risk of VTE recurrence

Table 6. Maximum Daily Pediatric Dosages for DOACs in Patients Less than 18 Years of Age: Factor Xa Inhibitors^1,2,7
Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage±
rivaroxaban (Xarelto®)	10 mg, 15 mg, 20 mg tablets, 1 mg/ 1 mL granules for suspension	Treatment of VTE and to reduce the risk of VTE recurrence: less than 18 years of age	2.6 kg to 2.9 kg^# 0.8 mg three times daily 3 kg to 3.9 kg^# 0.9 mg three times daily 4 kg to 4.9 kg^# 1.4 mg three times daily 5 kg to 6.9 kg^# 1.6 mg three times daily 7 kg to 7.9 kg^# 1.8 mg three times daily 8 kg to 8.9 kg^# 2.4 mg three times daily 9 kg to 9.9 kg^# 2.8 mg three times daily 10 kg to 11.9 kg^# 3 mg three times daily 12 kg to 29.9 kg^# 5 mg twice daily 30 kg to 49.9 kg^! 15 mg once daily greater than or equal to 50 kg*^! 20 mg once daily
		Thromboprophylaxis in patients 2 years of age and older with congenital heart disease who have undergone Fontan procedure	7 kg to 7.9 kg# 1.1 mg twice daily 8 kg to 9.9 kg# 1.6 mg twice daily 10 kg to 11.9 kg# 1.7 mg twice daily 12 kg to 19.9 kg# 2 mg twice daily 20 kg to 29.9 kg# 2.5 mg twice daily 30 kg to 49.9 kg# 7.5 mg once daily greater than or equal to 50 kg! 10 mg once daily

Legend

VTE = venous thromboembolism
± Patients less than 6 months of age should meet the following criteria: at birth at least 37 weeks gestation, have at least 10 days of oral feeding, and weigh greater than or equal to2.6 kg at the time of dosing
* Requires at least 5 days parenteral therapy before initiation of therapy for treatment of VTE
^ Following appropriate treatment duration of DVT or PE treatment if used to reduce the risk of VTE recurrence
# May only use granules for suspension
! May use granules for suspension or oral tablets