| TAH Drug Code | OELI |
|---|---|
| Indications | Prevention of stroke & systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), w/ >=1 risk factors [eg, prior stroke or transient ischaemic attack, age >=75 yr, HTN, DM, symptomatic heart failure (NYHA class >=II)]. Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) & pulmonary embolism (PE); prevention of recurrent DVT & PE in adult patients. |
| Dosing | Nonvalvular atrial fibrillation (to prevent stroke and systemic embolism): Oral: 5 mg twice daily unless patient has any 2 of the following: Age >=80 years, body weight =<60 kg, or serum creatinine >=1.5 mg/dL, then reduce dose to 2.5 mg twice daily. Deep venous thrombosis: Oral:Treatment: 10 mg twice daily for 7 days followed by 5 mg twice daily. Reduction in the risk of recurrence: 2.5 mg twice daily after at least 6 months of treatment for DVT |
| Hepatic Impairment | Dose adjustment required |
| Renal Impairment | Dose adjustment required |
| Contraindications | Hypersensitivity. Clinically significant active bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition at significant risk of major bleeding (eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding; recent brain/spinal injury, brain/spinal/ophth surgery, intracranial haemorrhage; known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment w/ any other anticoagulant eg, unfractionated heparin (UFH), low molecular wt heparins, heparin derivatives, oral anticoagulants except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter. |
| Adverse Effects | Common: Contusion (1.4-2.2%), Bleeding gums (<0.1-1.4%), Hematoma (DVT, 1.3-1.5%), Menorrhagia (1.4%), Bleeding from nose (DVT and pulmonary embolism, 1.5-3.6%; DVT prophylaxis, 0.1-<1%), Hemoptysis (<0.1-1.2%) Serious: Gastrointestinal hemorrhage (Atrial fibrillation, 0.83%/year; DVT prophylaxis, 0.1-<1%; DVT and pulmonary embolism, 0.1-<1%), Hematochezia (0.1-<1%), Rectal hemorrhage (<0.1-1%), Upper gastrointestinal bleeding, Hemorrhage (Atrial fibrillation, 2.08%/year ; DVT prophylaxis, 2.88-4.83%), Hemorrhage (0.1-1.4%), Hemorrhage, Major (0.1-2.13%), Hemorrhage, Operative (DVT prophylaxis, 0.1-<1%), Alkaline phosphatase above reference range (DVT prophylaxis, 0.1-<1%), Liver function tests outside reference range (DVT prophylaxis, 0.1-<1%), Serum bilirubin above reference range (DVT prophylaxis, 0.1-<1%), Hypersensitivity reaction (atrial fibrillation, <1%), Hemorrhage of muscle (<0.1-<1%), Extradural intracranial hematoma, Intracranial hemorrhage (0.33-0.34% per year), Non-traumatic spinal subdural hematoma, Traumatic spinal subdural hematoma, Conjunctival hemorrhage (0.1-<1%), Retinal hemorrhage (0.1-<1%), Hematuria (DVT, 1.4-2.1% ; DVT prophylaxis, 0.1-<1%) |
| Pregnancy | No (Limited) Human Data – Animal Data Suggest Risk |
| Lactation | No (Limited) Human Data - Potential Toxicity |
| More Info | UpToDate |
| TAH Drug Code | OELI2 |
|---|---|
| Indications | Prevention of stroke & systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), w/ >=1 risk factors [eg, prior stroke or transient ischaemic attack, age >=75 yr, HTN, DM, symptomatic heart failure (NYHA class >=II)]. Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) & pulmonary embolism (PE); prevention of recurrent DVT & PE in adult patients. |
| Dosing | Nonvalvular atrial fibrillation (to prevent stroke and systemic embolism): Oral: 5 mg twice daily unless patient has any 2 of the following: Age >=80 years, body weight =<60 kg, or serum creatinine >=1.5 mg/dL, then reduce dose to 2.5 mg twice daily. Deep venous thrombosis: Oral:Treatment: 10 mg twice daily for 7 days followed by 5 mg twice daily. Reduction in the risk of recurrence: 2.5 mg twice daily after at least 6 months of treatment for DVT |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment required |
| Contraindications | Hypersensitivity. Clinically significant active bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition at significant risk of major bleeding (eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding; recent brain/spinal injury, brain/spinal/ophth surgery, intracranial haemorrhage; known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment w/ any other anticoagulant eg, unfractionated heparin (UFH), low molecular wt heparins, heparin derivatives, oral anticoagulants except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter. |
| Adverse Effects | Common: Contusion (1.4-2.2%), Bleeding gums (<0.1-1.4%), Hematoma (DVT, 1.3-1.5%), Menorrhagia (1.4%), Bleeding from nose (DVT and pulmonary embolism, 1.5-3.6%; DVT prophylaxis, 0.1-<1%), Hemoptysis (<0.1-1.2%) Serious: Gastrointestinal hemorrhage (Atrial fibrillation, 0.83%/year; DVT prophylaxis, 0.1-<1%; DVT and pulmonary embolism, 0.1-<1%), Hematochezia (0.1-<1%), Rectal hemorrhage (<0.1-1%), Upper gastrointestinal bleeding, Hemorrhage (Atrial fibrillation, 2.08%/year ; DVT prophylaxis, 2.88-4.83%), Hemorrhage (0.1-1.4%), Hemorrhage, Major (0.1-2.13%), Hemorrhage, Operative (DVT prophylaxis, 0.1-<1%), Alkaline phosphatase above reference range (DVT prophylaxis, 0.1-<1%), Liver function tests outside reference range (DVT prophylaxis, 0.1-<1%), Serum bilirubin above reference range (DVT prophylaxis, 0.1-<1%), Hypersensitivity reaction (atrial fibrillation, <1%), Hemorrhage of muscle (<0.1-<1%), Extradural intracranial hematoma, Intracranial hemorrhage (0.33-0.34% per year), Non-traumatic spinal subdural hematoma, Traumatic spinal subdural hematoma, Conjunctival hemorrhage (0.1-<1%), Retinal hemorrhage (0.1-<1%), Hematuria (DVT, 1.4-2.1% ; DVT prophylaxis, 0.1-<1%) |
| Pregnancy | No (Limited) Human Data – Animal Data Suggest Risk |
| Lactation | No (Limited) Human Data - Potential Toxicity |
| More Info | UpToDate |