APIXABAN SANDOZ

Posology 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 adult 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. 4). 1). Treatment with apixaban in paediatric patients is based on weight-tiered dosing. 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 Apixaban tablets are not suitable for paediatric patients weighing less than 35 kg.

Refer to the summary of product characteristics for Apixaban granules in capsules for opening and Apixaban coated granules in sachets for these patients. 4). Missed dose for 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 When converting patients from vitamin K antagonist (VKA) therapy to Apixaban, warfarin or other VKA therapy should be discontinued and Apixaban started when the international normalised ratio (INR) is < 2.

Switching from Apixaban to VKA therapy When converting patients from Apixaban to VKA therapy, administration of Apixaban should be continued for at least 2 days after beginning VKA therapy. After 2 days of coadministration of Apixaban with VKA therapy, an INR should be obtained prior to the next scheduled dose of Apixaban.

1). Common adverse reactions were haemorrhage, contusion, epistaxis, and haematoma (see Table 3 for adverse reaction profile and frequencies by indication). 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 adults for NVAF and VTEp or 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. , haemorrhagic stroke or putamen, cerebellar, intraventricular, or subdural haemorrhages).

‡ Includes anaphylactic reaction, drug hypersensitivity, and hypersensitivity. § Includes heavy menstrual bleeding, intermenstrual bleeding, and vaginal haemorrhage. The use of apixaban may be associated with an increased risk of occult or overt bleeding from any tissue or organ, which may result in posthaemorrhagic anaemia.

1). Paediatric population The safety of apixaban has been investigated in 1 Phase I and 3 Phase II/III clinical studies including 970 patients. 1). The patients received weight adjusted doses of an age-appropriate formulation of apixaban.

Overall, the safety profile of apixaban in paediatric patients 28 days to < 18 years of age was similar to that in adults and was generally consistent across different paediatric age groups. The most commonly reported adverse reactions in paediatric patients were epistaxis, and abnormal vaginal haemorrhage (see Table 3 for adverse reaction profile and frequencies by indication).

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 drugs (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 planned treatment period with a P2Y12 inhibitor, with or without ASA, and oral anticoagulant (either apixaban or VKA) for 6 months.

1). 04% per year). 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).