Apixaban Abbreviated Prescribing Information

Abbreviated Prescribing Information: Apixaban 1mg/ml oral suspension. Consult Summary of Product Characteristics before prescribing. Presentation: an off-white oral suspension with each 1ml containing 1mg apixaban. Therapeutic Indications: for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery; for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II); for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for prevention of recurrent DVT and PE in adults. Posology: For prevention of VTE (VTEp): elective hip or knee replacement surgery: Apixaban 2.5 mg twice daily is recommended starting 12–24 hours post-surgery. Timing should balance VTE prophylaxis benefits with bleeding risks. Treatment duration is 32–38 days for hip replacement and 10–14 days for knee replacement. For prevention of stroke and systemic embolism in patients with NVAF: Apixaban 5 mg twice daily is recommended for NVAF, with a reduced dose of 2.5 mg twice daily in patients meeting at least two of the following: age ≥ 80, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL. Long-term therapy is advised. For treatment of DVT, PE and prevention of recurrent DVT and PE (VTEt): Apixaban is recommended at 10 mg twice daily for 7 days for DVT and PE, then 5 mg twice daily. For recurrent prevention, use 2.5 mg twice daily after 6 months of prior anticoagulation. Duration should be individualized based on benefit-risk assessment. Missed dose: If a dose is missed, the patient should take apixaban as soon as possible and resume the regular twice-daily schedule. Switching: Transitioning between parenteral anticoagulants and apixaban can occur at the next scheduled dose, but they should not be used concurrently. When transitioning from vitamin K antagonists (VKAs) to apixaban, discontinue warfarin or other VKAs and initiate apixaban once the international normalized ratio (INR) falls below 2. When switching from apixaban to VKA therapy, continue apixaban for at least 2 days after starting VKA. Check INR before the next apixaban dose and maintain coadministration until INR ≥ 2. Elderly patients, body weight and gender: No dose adjustment is required. Renal Impairment: In mild to moderate renal impairment, no dose adjustment is needed for the prevention of VTE in VTEp, DVT, PR and prevention of recurrent DVT and PR (VTEt), or for the prevention of stroke and systemic embolism in patients with NVAF unless serum creatinine ≥ 1.5 mg/dL with age ≥ 80 or weight ≤ 60 kg, in which case dose reduction is required. In severe impairment (creatinine clearance (CrCl) 15–29 mL/min), use apixaban cautiously for VTEp/VTEt and prescribe 2.5 mg twice daily for NVAF. Apixaban is not recommended for CrCl < 15 mL/min or dialysis patients due to lack of clinical data. Hepatic Impairment: Apixaban is contraindicated in hepatic disease with coagulopathy and bleeding risk, not recommended in severe hepatic impairment, and should be used cautiously in mild to moderate impairment or elevated liver enzymes, with liver function testing prior to initiation. Patients can continue apixaban use while undergoing catheter ablation. Apixaban can be initiated or continued in NVAF patients who may require cardioversion. For patients starting apixaban, administer 5 mg twice daily for at least 2.5 days (5 doses) before cardioversion. If dose reduction criteria apply, use 2.5 mg twice daily. If cardioversion is needed sooner, give a 10 mg loading dose at least 2 hours prior, followed by 5 mg twice daily; reduce to a 5 mg loading dose and 2.5 mg twice daily if indicated. Ensure apixaban adherence before cardioversion, and base treatment decisions on established anticoagulation guidelines. Limited experience exists with apixaban at the recommended NVAF dose when combined with antiplatelet agents in acute coronary syndrome (ACS) or post-percutaneous coronary intervention (PCI) patients after haemostasis. Method of Administration: oral. Paediatric population: The safety and efficacy of apixaban in individuals under 18 are unestablished; while data on thromboembolism prevention exist, no dosing recommendations can be made. Contra-indications: Hypersensitivity to the apixaban or to any of the excipients, active clinically significant bleeding, hepatic disease associated with coagulopathy and clinically relevant bleeding risk, in conditions posing significant bleeding risk, such as recent gastrointestinal ulceration, high-risk malignancies, CNS injuries or surgeries, intracranial haemorrhage, oesophageal varices, arteriovenous malformations, aneurysms, or major vascular abnormalities and concomitant use with other anticoagulants, except during therapy transitions, low-dose unfractionated heparin (UFH) for catheter patency, or UFH use during atrial fibrillation ablation. Special Warnings and Precautions for use: Haemorrhage risk: patients on apixaban should be closely monitored for bleeding, with caution in high-risk conditions and discontinuation if severe haemorrhage occurs. Routine monitoring isn’t required, but anti-Factor Xa assays may aid in special cases like overdose or emergency surgery. A reversal agent is available. Interaction with other medicinal products affecting haemostasis: concomitant use of apixaban with other anticoagulants is contraindicated due to increased bleeding risk. Antiplatelet agents, SSRIs, SNRIs, and NSAIDs, including ASA, further elevate bleeding risk and require caution. Post-surgical use of other platelet inhibitors is not recommended. In atrial fibrillation patients needing antiplatelet therapy, benefits and risks must be carefully assessed. Clinical studies show ASA significantly increases bleeding risk when combined with apixaban. Use of thrombolytic agents for the treatment of acute ischemic stroke: there is very limited experience with the use of thrombolytic agents for the treatment of acute ischemic stroke in patients administered apixaban. Patients with prosthetic heart valves: apixaban is not recommended for patients with prosthetic heart valves, as its safety and efficacy in this group have not been studied. Patients with antiphospholipid syndrome: direct acting Oral Anticoagulants, including apixaban, are not recommended for patients with antiphospholipid syndrome and prior thrombosis, especially those triple positive, due to higher recurrence risk compared to vitamin K antagonists. Surgery and invasive procedures: discontinue apixaban at least 48 hours before procedures with moderate to high bleeding risk, and 24 hours before low-risk procedures. If urgent intervention is needed, proceed with caution. Resume apixaban post-procedure once haemostasis is achieved. No interruption is needed for atrial fibrillation catheter ablation. Temporary discontinuation: stopping anticoagulants like apixaban increases thrombosis risk; avoid therapy lapses and restart treatment promptly if temporarily discontinued. Spinal/epidural anaesthesia or puncture: Neuraxial anaesthesia or puncture in patients on apixaban carries a risk of epidural or spinal haematoma, potentially causing paralysis. Risk increases with indwelling catheters, haemostasis-affecting drugs, or traumatic puncture. Catheters must be removed ≥5 hours before the first apixaban dose. Monitor for neurological symptoms and act urgently if detected. Due to limited experience, extreme caution is advised. If catheter use is necessary, allow 20–30 hours after the last dose before removal, omit one dose, and resume apixaban ≥5 hours post-removal. Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy: Apixaban is not recommended for haemodynamically unstable PE patients or those undergoing thrombolysis or embolectomy, as its safety and efficacy in these settings are unestablished. Patients with active cancer: In cancer patients, apixaban for DVT or PE requires careful benefit-risk assessment due to elevated risks of both thrombosis and bleeding. Patients with renal impairment: In severe renal impairment (CrCl 15–29 mL/min), apixaban may increase bleeding risk and should be used with caution for VTEp and VTEt. For NVAF, a reduced dose of 2.5 mg twice daily is recommended if CrCl is 15–29 mL/min and other risk factors are present. Apixaban is not recommended for CrCl < 15 mL/min or dialysis patients. Elderly patients: Advancing age may raise bleeding risk, and combining apixaban with ASA in elderly patients should be approached with caution due to increased haemorrhagic potential. Body weight: Low body weight (< 60 kg) may increase haemorrhagic risk. Patients with hepatic impairment: Apixaban is contraindicated in hepatic disease with coagulopathy and bleeding risk, not recommended in severe hepatic impairment, and should be used cautiously in mild to moderate impairment. Elevated liver enzymes or bilirubin warrant caution, and liver function should be assessed before starting therapy. Interaction with inhibitors of both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp): Apixaban is not recommended with strong dual CYP3A4 and P-gp inhibitors (e.g., azole-antimycotics, HIV protease inhibitors), as they may significantly increase apixaban exposure, especially with additional risk factors like severe renal impairment. Interaction with inducers of both CYP3A4 and P-gp: Strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin) may reduce apixaban exposure by ~50%, lowering efficacy and increasing bleeding risk. Use with caution for VTE prevention and NVAF; avoid for DVT and PE treatment. Hip fracture surgery: Apixaban is not recommended for patients undergoing hip fracture surgery due to lack of efficacy and safety data. Laboratory parameters: Apixaban affects clotting tests (prothrombin time, INR, activated partial thromboplastin time) as expected, but changes at therapeutic doses are minimal and highly variable. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: not applicable. A list of common and serious adverse reactions is presented below: Common adverse reactions associated with apixaban for prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery include – anaemia, haemorrhage, haematoma, nausea and contusion. Common adverse reactions associated with apixaban for prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors include – anaemia, eye haemorrhage including conjunctival haemorrhage, haemorrhage, haematoma, hypotension including procedural hypotension, epistaxis, nausea, gastrointestinal haemorrhage, rectal haemorrhage, gingival bleeding, gamma-glutamyl transferase increased, haematuria and contusion. Common adverse reactions associated with apixaban for treatment of DVT and PE, and prevention of recurrent DVT and PE include – anaemia, thrombocytopenia, haemorrhage, haematoma, epistaxis, nausea, gastrointestinal haemorrhage, mouth haemorrhage, rectal haemorrhage, gingival bleeding, gamma-glutamyl transferase increased, alanine aminotransferase increased, skin rash, haematuria, abnormal vaginal haemorrhage, urogenital haemorrhage and contusion. Serious adverse reactions: hypersensitivity, anaphylaxis, angioedema, brain haemorrhage, intra-abdominal haemorrhage, haemoptysis, respiratory tract haemorrhage, haemorrhoidal haemorrhage, haematochezia, retroperitoneal haemorrhage, erythema multiforme, cutaneous vasculitis, muscle haemorrhage, anticoagulant related nephropathy, occult blood positive, traumatic haemorrhage, post procedural haemorrhage including post procedural haematoma, wound haemorrhage, vessel puncture site haematoma and catheter site haemorrhage, wound secretion, incision site haemorrhage (including incision site haematoma) and operative haemorrhage. Refer to the SmPC for full details of other adverse reactions. Legal Category: Prescription only medicine. Pack Size and NHS Price: 150 ml – £53.00. Marketing Authorisation Number: PL 00427/0325. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [October-2025]