Apixaban Accord

5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window.

In patients undergoing hip replacement surgery The recommended duration of treatment is 32 to 38 days. 3 In patients undergoing knee replacement surgery The recommended duration of treatment is 10 to 14 days. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) The recommended dose of apixaban is 5 mg taken orally twice daily.

5 mg/dL (133 micromole/L). Therapy should be continued long-term. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) in adults The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily.

, recent surgery, trauma, immobilisation). 5 mg taken orally twice daily. 1). 4). 1). The recommended dose of apixaban in paediatric patients weighing ≥ 35 kg is shown in Table 2.

Table 2:

Dose recommendation for treatment of VTE and prevention of recurrent VTE in paediatric patients weighing ≥ 35 kg (after initial parenteral anticoagulation) Days 1-7 Day 8 and beyond Body weight (kg) Dosing schedule Maximum daily dose Dosing schedule Maximum daily dose ≥ 35 10 mg twice daily 20 mg 5 mg twice daily 10 mg For paediatric patients weighing < 35 kg, refer to the summary of product characteristics for apixaban granules in capsules for opening and apixaban coated granules in sachets.

4). Missed dose in adults and paediatric patients A missed morning dose should be taken immediately when it is noticed, and it may be taken together with the evening dose. A missed evening dose can only be taken during the same evening, the patient should not take two doses the next morning.

The patient should continue with the intake of the regular dose twice daily as recommended on the following day. 5). These medicinal products should not be administered simultaneously. Switching from vitamin K antagonist (VKA) therapy to Apixaban Accord When converting patients from vitamin K antagonist (VKA) therapy to Apixaban Accord, warfarin or other VKA therapy should be discontinued and Apixaban Accord started when the international normalised ratio (INR) is < 2.

1). Common adverse reactions were haemorrhage, contusion, epistaxis, and haematoma (see Table 3 for adverse reaction profile and frequencies by indication). 5 mg twice daily experienced adverse reactions. The overall incidence of adverse reactions related to bleeding with apixaban was 10% in the apixaban vs enoxaparin studies.

6% in the apixaban vs acetylsalicylic acid study. 76%/year. 18%/year. 1). Tabulated list of adverse reactions Table 3 shows the adverse reactions ranked under headings of system organ class and frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data) in aults for VTEp, NVAF, and VTEt and in paediatric patients from 28 days to < 18 years of age for VTEt and prevention of recurrent VTE.

The frequencies of adverse reactions reported in Table 3 for paediatric patients are derived from study CV185325, in which they received apixaban for treatment of VTE and prevention of recurrent VTE.

Table 3:

Tabulated adverse reactions System organ class Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp) Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF) Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt) in adult patients Treatment of VTE and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age Blood and lymphatic system disorders Anaemia Common Common Common Common Thrombocytopenia Uncommon Uncommon Common Common Immune system disorders Hypersensitivity, allergic oedema and anaphylaxis Rare Uncommon Uncommon Common‡ Pruritus Uncommon Uncommon Uncommon* Common Angioedema Not known Not known Not known Not known Nervous system disorders Brain haemorrhage† Not known Uncommon Rare Not known Eye disorders Eye haemorrhage (including conjunctival haemorrhage) Rare Common Uncommon Not known Vascular disorders Haemorrhage, haematoma Common Common Common Common Hypotension (including procedural hypotension) Uncommon Common Uncommon Common Intra-abdominal haemorrhage Not known Uncommon Not known Not known Respiratory, thoracic and mediastinal disorders Epistaxis Uncommon Common Common Very common Haemoptysis Rare Uncommon Uncommon Not known Respiratory tract haemorrhage Not known Rare Rare Not known Gastrointestinal disorders Nausea Common Common Common Common Gastrointestinal haemorrhage Uncommon Common Common Not known Haemorrhoidal haemorrhage Not known Uncommon Uncommon Not known Mouth haemorrhage Not known Uncommon Common Not known 15 System organ class Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp) Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF) Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt) in adult patients Treatment of VTE and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age Haematochezia Uncommon Uncommon Uncommon Common Rectal haemorrhage, gingival bleeding Rare Common Common Common Retroperitoneal haemorrhage Not known Rare Not known Not known Hepatobiliary disorders Liver function test abnormal, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased Uncommon Uncommon Uncommon Common Gamma-glutamyltransferase increased Uncommon Common Common Not known Alanine aminotransferase increased Uncommon Uncommon Common Common Skin and subcutaneous tissue disorders Skin rash Not known Uncommon Common Common Alopecia Rare Uncommon Uncommon Common Erythema multiforme Not known Very rare Not known Not known Cutaneous vasculitis Not known Not known Not known Not known Musculoskeletal and connective tissue disorders Muscle haemorrhage Rare Rare Uncommon Not known Renal and urinary disorders Haematuria Uncommon Common Common Common Anticoagulant-related nephropathy Not known Not known Not known Not known Reproductive system and breast disorders Abnormal vaginal haemorrhage, urogenital haemorrhage Uncommon Uncommon Common Very common§ General disorders and administration site conditions Application site bleeding Not known Uncommon Uncommon Not known Investigations Occult blood positive Not known Uncommon Uncommon Not known Injury, poisoning and procedural complications Contusion Common Common Common Common 16 System organ class Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp) Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF) Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt) in adult patients Treatment of VTE and prevention of recurrent VTE in paediatric […]

Haemorrhage risk As with other anticoagulants, patients taking apixaban are to be carefully observed for signs of bleeding. It is recommended to be used with caution in conditions with increased risk of haemorrhage. 9). 1). A specific reversal agent (andexanet alfa) antagonising the pharmacodynamic effect of apixaban is available for adults.

However, its safety and efficacy have not been established in paediatric patients (refer to the summary of product characteristics of andexanet alfa). Transfusion of fresh frozen plasma, administration of prothrombin complex concentrates (PCCs), or recombinant factor VIIa may be considered.

However, there is no clinical experience with the use of 4-factor PCC products to reverse bleeding in paediatric and adult patients who have received apixaban. 3). 5). Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory medicinal products (NSAIDs), including acetylsalicylic acid.

5). 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.

6% per year. 1). A clinical study enrolled patients with atrial fibrillation with ACS and/or undergoing PCI and a plannedtreatment period with a P2Y12 inhibitor, with or without ASA, and oral anticoagulant (either apixabanor VKA) for 6 months.

1). 04% per year). 8 In study CV185325, no clinically important bleeding events were reported in the 12 paediatric patients treated with apixaban and ASA ≤ 165 mg daily concomitantly. 5). 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.

1.  Active clinically significant bleeding. 2).  Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

5).