Apixaban Atlanta Medicare Special Precautions

Haemorrhage risk: As with other anticoagulants, patients taking Apixaban are to be carefully observed for signs of bleeding. Apixaban is recommended to be used with caution in conditions with increased risk of haemorrhage, such as: congenital or acquired bleeding disorders; active ulcerative gastrointestinal disease; bacterial endocarditis; thrombocytopenia; platelet disorders; history of hemorrhagic stroke; severe uncontrolled hypertension; and recent brain, spinal, or ophthalmological surgery. Apixaban is not recommended in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk. Apixaban administration should be discontinued if severe haemorrhage occurs (see Adverse Reactions and Overdosage).
In the event of hemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. The initiation of appropriate treatment, e.g., surgical hemostasis or the transfusion of fresh frozen plasma, should be considered. If life-threatening bleeding cannot be controlled by the previously mentioned measures, administration of prothrombin complex concentrates (PCCs) or recombinant factor VIIa may be considered. Reversal of apixaban pharmacodynamic effects, as demonstrated by changes in the thrombin generation assay, has been demonstrated after administration of 4-factor PCCs in healthy subjects. However, there is no clinical experience with the use of 4-factor PCC products to reverse bleeding in individuals who have received apixaban. Currently, there is no experience with the use of recombinant factor VIIa in individuals receiving apixaban.
Interaction with other medicinal products affecting haemostasis: The concomitant use of apixaban with antiplatelet agents increases the risk of bleeding.
Care is to be taken if patients are treated concomitantly with non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Following surgery, other platelet aggregation inhibitors or other antithrombotic agents are not recommended concomitantly with apixaban (see Interactions).
In patients with atrial fibrillation and conditions that warrant mono or dual antiplatelet therapy, a careful assessment of the potential benefits against the potential risks should be made before combining this therapy with apixaban.
In a clinical trial of patients with atrial fibrillation, concomitant use of ASA increased the major bleeding risk on apixaban from 1.8% per year to 3.4% per year and increased the bleeding risk on warfarin from 2.7% per year to 4.6% per year. In this clinical trial, there was limited (2.3%) use of concomitant dual antiplatelet therapy with apixaban.
In a clinical trial of high-risk post-acute coronary syndrome patients, characterised by multiple cardiac and non-cardiac comorbidities, who received ASA or the combination of ASA and clopidogrel, a significant increase in bleeding risk was reported for apixaban compared to placebo.
Patients with prosthetic heart valves: Safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of apixaban is not recommended in this setting.
Temporary discontinuation of apixaban: Discontinuing anticoagulants, including Apixaban, for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of thrombosis. Avoid lapses in therapy, and if anticoagulation with apixaban must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.
Spinal/epidural anaesthesia or puncture: Prevention of VTE: elective hip or knee replacement surgery: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis. Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior to the first dose of apixaban. The risk may also be increased by traumatic or repeated epidural or spinal puncture. Patients are to be frequently monitored for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary. 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.
Acute PE in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy: Treatment of VTE: Initiation of apixaban is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with haemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
Patients with renal impairment: Prevention of VTE in elective hip or knee replacement surgery: Because there is limited clinical experience in patients with creatinine clearance <15 mL/min and no data in patients undergoing dialysis, apixaban is not recommended in these patients (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Prevention of stroke and systemic embolism in patients with NVAF: There are no data inpatients undergoing dialysis, therefore, apixaban is not recommended in these patients (see Pharmacology: Pharmacokinetics under Actions).
Treatment of VTE: Because there is limited clinical experience in patients with creatinine clearance <15 mL/min and no data in patients undergoing dialysis, apixaban is not recommended in these patients (see Pharmacology: Pharmacokinetics under Actions).
Patients with hepatic impairment: Apixaban is not recommended in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). Apixaban may be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B) (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Interaction with inhibitors of both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp): Apixaban can be administered with caution in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g., ritonavir). These medicinal products may increase apixaban exposure by 2-fold (see Interactions).
Interaction with inducers of both CYP3A4 and P-gp: Prevention of VTE in elective hip or knee replacement surgery: The concomitant use of apixaban with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to a ~50% reduction in apixaban exposure. Use caution when co-administering apixaban with strong inducers of both CYP3A4 and P-gp (see Interactions).
Prevention of stroke and systemic embolism in patients with NVAF: The concomitant use of apixaban with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to a ~50% reduction in apixaban exposure. Use caution when co-administering apixaban with strong inducers of both CYP3A4 and P-gp (see Interactions).
Treatment of VTE: The concomitant use of apixaban with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to a ~50% reduction in apixaban exposure. For the treatment of DVT or PE, apixaban is not recommended in patients receiving concomitant systemic treatment with strong inducers of both CYP3A4 and P-gp (see Interactions). For prevention of recurrent DVT and PE, use caution when co-administering apixaban with strong inducers of both CYP3A4 and P-gp (see Interactions).
Hip fracture surgery: Prevention of VTE in elective hip or knee replacement surgery: Apixaban has not been studied in clinical trials in patients undergoing hip fracture surgery to evaluate efficacy and safety in these patients. Therefore, apixaban is not recommended in these patients.
Effects on ability to drive and use machines: Apixaban has no or negligible influence on the ability to drive and use machines.