Classes
DEA Class; Rx
Common Brand Names; Savaysa
- Factor Xa Inhibitors
Description
Oral anticoagulant
For risk reduction of stroke in atrial fibrillation and treatment of DVT and PE after initial injectable therapy
Dose reduction required in some patients treated for DVT or PE and a CrCl of 15 to 50 mL/min or a body weight of 60 kg or less or also receiving P-gp inhibitors
Indications
Indicated to reduce risk of stroke and systemic embolism associated with nonvalvular atrial fibrillation (NVAF)
Indicated for treatment of deep vein thrombosis (DVT) and pulmonary embolus (PE) in patients who have been initially treated with a parenteral anticoagulant for 5-10 days
Contraindications
Active pathological bleeding
Adverse Effects
Abnormal LFTs (4.8%)
Rash (4.2%)
Abnormal LFTs (7.8%)
Rash (3.6%)
Anemia (1.7%)
Interstitial lung disease (0.2%)
Clinically relevant nonmajor bleeding (9.4%); warfarin (10.9%)
Anemia-related adverse events (9.6%); warfarin (6.8%)
Gastrointestinal bleeding
Major GI bleed (1.8%); warfarin (1.3%)
Upper GI (1.06%); warfarin (0.74%)
Lower GI (0.73%); warfarin (0.54%)
Severe, caused hemodynamic compromise requiring intervention (0.14%); warfarin (0.14%)
Fatal (<0.1%); warfarin (<0.1%)
Major bleeding
Major (3.1%); warfarin (3.7%)
Intracranial (0.5%); warfarin (1%)
Type of intracranial bleeding
Hemorrhagic stroke (0.3%); warfarin (0.6%)
Other ICH (0.2%); warfarin (0.5%)
Fatal bleeding
Fatal (1.8%); warfarin (0.4%)
ICH (0.2%); warfarin (0.4%)
Non-intracranial (<0.1%); warfarin (<0.1%)
Warnings
Efficacy reduced in patients with nonvalvular atrial fibrillation (NVAF) with CrCl >95 mL/min (see Black Box Warnings)
Increased risk of stroke with discontinuation in patients with NVAF (see Black Box Warnings)
The risk of developing epidural or spinal hematoma may be increased by postoperative use of indwelling epidural catheters or concomitant use of medicinal products affecting hemostasis; indwelling epidural or intrathecal catheters should not be removed earlier than 12 hours after last administration of therapy; the next dose should not be administered earlier than 2 hours after removal of catheter; the risk may also be increased by traumatic or repeated epidural or spinal puncture
Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis
Do not use neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture; patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis (see Black Box Warnings)
Increases the risk of bleeding and can cause serious and potentially fatal bleeding; promptly evaluate any signs or symptoms of blood loss; discontinue if patient experiences active pathological bleeding; concomitant drugs that affect coagulation can increase this risk
Not recommended for patients with mechanical heart valves or moderate-to-severe mitral stenosis; safety and efficacy have not been established
Patients with triple positive antiphospholipid syndrome have experienced increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy; direct-acting oral anticoagulants not recommended in this patient population
Pregnancy and Lactation
Available data about use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes; in animal developmental studies, no adverse developmental effects were seen when administered orally to pregnant rats and rabbits during organogenesis at up to 16-times and 8-times, respectively, the human exposure, when based on body surface area and AUC, respectively
There are no data on presence in human milk, or effects on breastfeeding infant or on milk production; drug was present in rat milk; because of potential for serious adverse reactions in nursing infants, including hemorrhage, advise patients that breastfeeding is not recommended during treatment
Maximum Dosage
60 mg/day PO.
60 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Edoxaban
tablet
- 15mg
- 30mg
- 60mg
