Apixaban Sandoz Dosage/Direction for Use

Posology: Prevention of VTE (VTE): elective hip or knee replacement surgery: The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
In patients undergoing hip replacement surgery: The recommended duration of treatment is 32 to 38 days.
In patients undergoing knee replacement surgery: The recommended duration of treatment is 10 to 14 days.
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF): The recommended dose of apixaban is 5 mg taken orally twice daily.
Dose reduction in NVAF patients: The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE): 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.
The recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily. When prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose should be initiated following completion of 6 months of treatment with apixaban 5 mg twice daily or with another anticoagulant, as indicated in Table 1 as follows (see also PHARMACOLOGY: Pharmacodynamics under Actions). (See Table 1.)

Click on icon to see table/diagram/image

The duration of overall therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see Precautions).
Missed dose: If a dose is missed, the patient should take Apixaban Sandoz immediately and then continue with twice daily intake as before.
Switching: Switching treatment from parenteral anticoagulants to Apixaban Sandoz (and vice versa) can be done at the next scheduled dose (see Interactions). These medicinal products should not be administered simultaneously.
Switching from vitamin K antagonist (VKA) therapy to Apixaban Sandoz: When converting patients from vitamin K antagonist (VKA) therapy to Apixaban Sandoz, warfarin or other VKA therapy should be discontinued and Apixaban Sandoz started when the international normalised ratio (INR) is < 2.
Switching from Apixaban Sandoz to VKA therapy: When converting patients from Apixaban Sandoz to VKA therapy, administration of Apixaban Sandoz should be continued for at least 2 days after beginning VKA therapy. After 2 days of coadministration of Apixaban Sandoz with VKA therapy, an INR should be obtained prior to the next scheduled dose of Apixaban Sandoz. Coadministration of Apixaban Sandoz and VKA therapy should be continued until the INR is ≥ 2.
Renal impairment: In patients with mild or moderate renal impairment, the following recommendations apply: For the prevention of VTE in elective hip or knee replacement surgery (VTEp), for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), no dose adjustment is necessary (see PHARMACOLOGY: Pharmacokinetics under Actions).
For the prevention of stroke and systemic embolism in patients with NVAF and serum creatinine ≥ 1.5 mg/dL (133 micromole/L) associated with age ≥ 80 years or body weight ≤ 60 kg, a dose reduction is necessary and described previously. In the absence of other criteria for dose reduction (age, body weight), no dose adjustment is necessary (see PHARMACOLOGY: Pharmacokinetics under Actions).
In patients with severe renal impairment (creatinine clearance 15-29 mL/min) the following recommendations apply (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions): For the prevention of VTE in elective hip or knee replacement surgery (VTEp), for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) apixaban is to be used with caution.
In patients with creatinine clearance < 15 mL/min, or in patients undergoing dialysis, there is no clinical experience therefore apixaban is not recommended (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
Hepatic impairment: Apixaban is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see Contraindications).
It is not recommended in patients with severe hepatic impairment (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
It should be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B). No dose adjustment is required in patients with mild or moderate hepatic impairment (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
Patients with elevated liver enzymes alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2 x ULN or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials. Therefore Apixaban should be used with caution in this population (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions). Prior to initiating Apixaban, liver function testing should be performed.
Body weight: VTEp and VTEt - No dose adjustment required (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
NVAF - No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction in NVAF patients as previously mentioned).
Gender: No dose adjustment required (see PHARMACOLOGY: Pharmacokinetics under Actions).
Elderly: VTEp and VTEt - No dose adjustment required (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
NVAF - No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction in NVAF patients as previously mentioned).
Patients undergoing catheter ablation (NVAF): Patients can continue apixaban use while undergoing catheter ablation (see Contraindications, Precautions and Interactions).
Patients undergoing cardioversion: Apixaban can be initiated or continued in NVAF patients who may require cardioversion.
For patients not previously treated with anticoagulants, exclusion of left atrial thrombus using an image guided approach (e.g. transesophageal echocardiography (TEE) or computed tomographic scan (CT)) prior to cardioversion should be considered, in accordance with established medical guidelines.
For patients initiating treatment with apixaban, 5 mg should be given twice daily for at least 2.5 days (5 single doses) before cardioversion to ensure adequate anticoagulation (see PHARMACOLOGY: Pharmacodynamics under Actions). The dosing regimen should be reduced to 2.5 mg apixaban given twice daily for at least 2.5 days (5 single doses) if the patient meets the criteria for dose reduction (see Dose reduction in NVAF patients and Renal impairment as previously mentioned).
If cardioversion is required before 5 doses of apixaban can be administered, a 10 mg loading dose should be given, followed by 5 mg twice daily. The dosing regimen should be reduced to a 5 mg loading dose followed by 2.5 mg twice daily if the patient meets the criteria for dose reduction (see Dose reduction in NVAF patients and Renal impairment as previously mentioned). The administration of the loading dose should be given at least 2 hours before cardioversion (see PHARMACOLOGY: Pharmacodynamics under Actions).
For all patients undergoing cardioversion, confirmation should be sought prior to cardioversion that the patient has taken apixaban as prescribed. Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Patients with NVAF and acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI): There is limited experience of treatment with apixaban at the recommended dose for NVAF patients when used in combination with antiplatelet agents in patients with ACS and/or undergoing PCI after haemostasis is achieved (see Precautions and PHARMACOLOGY: Pharmacodynamics under Actions).
Paediatric population: The safety and efficacy of Apixaban in children and adolescents below age 18 have not been established. No data are available.
Method of administration: Oral use.
Apixaban should be swallowed with water, with or without food.
For patients who are unable to swallow whole tablets, Apixaban tablets may be crushed and suspended in water, or 5% dextrose in water (D5W), or apple juice or mixed with apple puree and immediately administered orally (see PHARMACOLOGY: Pharmacokinetics under Actions). Alternatively, Apixaban tablets may be crushed and suspended in 60 mL of water or D5W and immediately delivered through a nasogastric tube (see PHARMACOLOGY: Pharmacokinetics under Actions).