What is the initial dose of Apixaban (apixaban) for a patient with pulmonary embolism (PE) and deep vein thrombosis (DVT)?

From the Guidelines

For a patient with both pulmonary embolism (PE) and deep vein thrombosis (DVT), the recommended apixaban dosing regimen is 10 mg taken orally twice daily for the first 7 days, followed by 5 mg twice daily thereafter. This dosing regimen is based on the most recent and highest quality evidence available, including the 2018 European Heart Rhythm Association practical guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation 1. The initial higher dose of 10 mg twice daily is crucial for rapid anticoagulation during the acute phase of treatment, and the subsequent dose of 5 mg twice daily is effective for long-term prevention of recurrent VTE.

Key Considerations

• The duration of therapy typically ranges from 3-6 months, but may be extended based on risk factors for recurrence.
• Dose adjustment is necessary for patients with severe renal impairment (creatinine clearance 15-29 mL/min) to 2.5 mg twice daily after the initial 7-day period.
• Apixaban should be used cautiously in patients with other anticoagulants, antiplatelets, or high bleeding risk.
• The medication works by directly inhibiting Factor Xa, preventing thrombin formation and clot development.
• Patients should take apixaban with or without food at approximately 12-hour intervals and should be counseled about bleeding risks and the importance of not missing doses.

Evidence Summary

The evidence from the 2018 European Heart Rhythm Association practical guide 1 and other studies, such as the 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism 2 and the 2016 Chest guideline on antithrombotic therapy for VTE disease 3, supports the use of apixaban for the treatment of PE and DVT. These studies demonstrate that apixaban is effective in preventing recurrent VTE and reducing the risk of major bleeding compared to conventional therapy. However, the most recent and highest quality evidence is from the 2018 European Heart Rhythm Association practical guide 1, which provides the recommended dosing regimen for apixaban in patients with PE and DVT.

From the FDA Drug Label

2.1 Recommended Dose ... Treatment of DVT and PE The recommended dose of apixaban tablets is 10 mg taken orally twice daily for the first 7 days of therapy. The initial dose of Apixaban for a patient with pulmonary embolism (PE) and deep vein thrombosis (DVT) is 10 mg taken orally twice daily for the first 7 days of therapy 4.

From the Research

Initial Dose of Apixaban for Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT)

• The initial dose of apixaban for patients with pulmonary embolism (PE) and deep vein thrombosis (DVT) is not explicitly stated in the provided studies 5, 6, 7, 8, 9.
• However, study 7 mentions that apixaban is an oral factor Xa inhibitor with a rapid onset of action and predictable pharmacokinetics that allows a fixed dose regimen, but it does not specify the initial dose.
• Study 5 states that the acute treatment of venous thromboembolism (VTE) is commenced with intensified anticoagulation (AC), either with parenteral AC or higher initial doses of apixaban or rivaroxaban, but it does not provide the specific initial dose of apixaban.
• Study 6 discusses the lead-in doses of apixaban for the treatment of VTE, but it does not provide information on the initial dose for patients with PE and DVT.

Treatment of Venous Thromboembolism (VTE)

• Study 8 states that patients with objectively diagnosed DVT or PE should receive therapeutic anticoagulation for a minimum of 3 months 8.
• Study 9 recommends a minimum of 3 to 6 months of anticoagulation following a first episode of idiopathic DVT and any PE 9.
• Study 7 mentions that extended anticoagulation with apixaban reduces the risk of recurrent venous thromboembolism without an increase in the rate of major bleeding 7.

Anticoagulant Treatment

• Study 5 summarizes current evidence and guideline recommendations concerning diagnosis and treatment of DVT and PE, including the use of apixaban and rivaroxaban 5.
• Study 8 provides an overview of the currently available treatment modalities of acute VTE and secondary prophylaxis, including the use of direct oral anticoagulants (DOAC) such as apixaban 8.