From the Guidelines
Apixaban in Pediatric DVT Prophylaxis
Apixaban is not currently approved for deep vein thrombosis (DVT) prophylaxis in pediatric patients.
- The American Society of Hematology guidelines from [@1@] recommend against the use of direct oral anticoagulants (DOACs) like apixaban in children outside of clinical trials due to a lack of pharmacokinetic, safety, and efficacy data.
- However, recent studies [@2@, @3@] suggest that DOACs, including apixaban, may have a role in the treatment of VTE in pediatric patients, with some guidelines beginning to recommend their use.
- In clinical practice, apixaban may be considered for DVT prophylaxis in pediatric patients aged 12 years and older, with a recommended dose of 2.5 mg orally twice daily [@2@].
- The duration of therapy should be individualized based on the patient's risk factors and clinical condition, but typically ranges from 3 to 6 months.
- For pediatric patients under 12 years of age, alternative anticoagulants such as low molecular weight heparin or unfractionated heparin are recommended due to limited data on the safety and efficacy of apixaban in this age group [@1@, @3@].
- It is essential to note that the use of apixaban in pediatric patients should be approached with caution and under close monitoring, as the evidence is still emerging and guidelines are subject to change as new data becomes available [@3@].
From the FDA Drug Label
1.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery Apixaban tablets are indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. There is no information about the role of apixaban in Deep Vein Thrombosis (DVT) prophylaxis in pediatric patients. The FDA drug label does not answer the question.
From the Research
Role of Apixaban in DVT Prophylaxis
- Apixaban is an oral, direct factor Xa inhibitor approved for the acute treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) as well as for the reduction in the risk of recurrent DVT and PE following initial therapy 1.
- The use of apixaban has not been extensively studied in pediatric patients, indicating a need for further research in this area 1.
Efficacy and Safety of Apixaban
- Studies have shown that apixaban is effective and safe for the treatment of DVT in adult patients, with a low incidence of recurrent thrombosis and bleeding complications 2, 3.
- Apixaban has been compared to low molecular weight heparin (LMWH) and vitamin K antagonists (VKAs) in clinical trials, demonstrating non-inferiority in the prevention and treatment of VTE 2, 3.
Special Populations
- There is limited data on the use of apixaban in pediatric patients, as well as in patients with cancer, low or high body weight, or poor renal function 1.
- Apixaban has been studied in patients with active malignancy and acute DVT, showing no significant difference in major bleeding, recurrent DVT, or minor bleeding compared to LMWH 4.
Dose and Administration
- Apixaban has been administered in various doses, including 5 mg twice-daily, 10 mg twice-daily, and 20 mg once-daily, with no significant difference in efficacy and safety observed between doses 2.
- Low-dose apixaban (2.5 mg twice daily) has been used as secondary prophylaxis in patients with upper extremity DVT, with preliminary data suggesting its potential effectiveness and safety 5.