Active Ingredient: Apixaban
Treatment of venous thromboembolism (VTE) in paediatric patients from 28 days to less than 18 years of age.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in days is ≥ 28 and patient weight is ≥ 4 kg and patient weight is < 5 kg, oral, 0.6 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 4 kg and patient weight is < 5 kg, oral, 0.3 milligrams apixaban, 2 times daily.
Regimen B: In case that patient age in days is ≥ 28 and patient weight is ≥ 5 kg and patient weight is < 6 kg, oral, 1 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 5 kg and patient weight is < 6 kg, oral, 0.5 milligrams apixaban, 2 times daily.
Regimen C: In case that patient age in days is ≥ 28 and patient weight is ≥ 6 kg and patient weight is < 9 kg, oral, 2 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 6 kg and patient weight is < 9 kg, oral, 1 milligrams apixaban, 2 times daily.
Regimen D: In case that patient age in days is ≥ 28 and patient weight is ≥ 9 kg and patient weight is < 12 kg, oral, 3 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 9 kg and patient weight is < 12 kg, oral, 1.5 milligrams apixaban, 2 times daily.
Regimen E: In case that patient age in days is ≥ 28 and patient weight is ≥ 12 kg and patient weight is < 18 kg, oral, 4 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 12 kg and patient weight is < 18 kg, oral, 2 milligrams apixaban, 2 times daily.
Regimen F: In case that patient age in days is ≥ 28 and patient weight is ≥ 18 kg and patient weight is < 25 kg, oral, 6 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 18 kg and patient weight is < 25 kg, oral, 3 milligrams apixaban, 2 times daily.
Regimen G: In case that patient age in days is ≥ 28 and patient weight is ≥ 25 kg and patient weight is < 35 kg, oral, 8 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 25 kg and patient weight is < 35 kg, oral, 4 milligrams apixaban, 2 times daily.
Regimen H: In case that patient age in days is ≥ 28 and patient weight is ≥ 35 kg, oral, 10 milligrams apixaban, 2 times daily, over the duration of 1 to 7 days. Afterwards, in case that patient age in days is ≥ 28 and patient weight is ≥ 35 kg, oral, 5 milligrams apixaban, 2 times daily.
Apixaban treatment for paediatric patients from 28 days to less than 18 years of age should be initiated following at least 5 days of initial parenteral anticoagulation therapy.
The recommended dose of apixaban is based on the patient’s weight as shown in Table 1. The dose should be adjusted according to weight-tier as treatment progresses.
For weight not listed in the dosing table, no dosing recommendation can be provided.
Table 1. Dose recommendations for treatment of VTE in paediatric patients, by weight in kg:
| Days 1-7 | Day 8 and beyond | |||
| Body weight (kg) | Dosing schedule | Maximum daily dose | Dosing schedule | Maximum daily dose |
| 4 to <5 | 0.6 mg twice daily | 1.2 mg | 0.3 mg twice daily | 0.6 mg |
| 5 to <6 | 1 mg twice daily | 2 mg | 0.5 mg twice daily | 1 mg |
| 6 to <9 | 2 mg twice daily | 4 mg | 1 mg twice daily | 2 mg |
| 9 to <12 | 3 mg twice daily | 6 mg | 1.5 mg twice daily | 3 mg |
| 12 to <18 | 4 mg twice daily | 8 mg | 2 mg twice daily | 4 mg |
| 18 to <25 | 6 mg twice daily | 12 mg | 3 mg twice daily | 6 mg |
| 25 to <35 | 8 mg twice daily | 16 mg | 4 mg twice daily | 8 mg |
| ≥35 | 10 mg twice daily | 20 mg | 5 mg twice daily | 10 mg |
Based on VTE treatment guidelines in the paediatric population, duration of overall therapy should be individualised after careful assessment of the treatment benefit and the risk for bleeding.
A missed morning dose should be taken immediately when it is noticed, and it may be taken together with the evening dose. A missed evening dose can only be taken during the same evening, the patient should not take two doses the next morning. The patient should continue with the intake of the regular dose twice daily as recommended on the following day.
Switching treatment from parenteral anticoagulants to apixaban (and vice versa) can be done at the next scheduled dose. These medicinal products should not be administered simultaneously.
When converting patients from vitamin K antagonist (VKA) therapy to apixaban, warfarin or other VKA therapy should be discontinued and apixaban started when the international normalised ratio (INR) is <2.
No data are available for paediatric patients.
When converting patients from apixaban to VKA therapy, administration of apixaban should be continued for at least 2 days after beginning VKA therapy. After 2 days of coadministration of apixaban with VKA therapy, an INR should be obtained prior to the next scheduled dose of apixaban. Coadministration of apixaban and VKA therapy should be continued until the INR is ≥2.
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