ELIQUIS TABLET 5MG [SIN14407P]

Product Info

ELIQUIS TABLET 5MG

[SIN14407P]

4.1 Therapeutic indications

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).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Posology

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
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 (VTEt)
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. As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilisation).

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 below (see also section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The duration of overall therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Missed dose
If a dose is missed, the patient should take ELIQUIS immediately and then continue with twice daily intake as before.

Switching
Switching treatment from parenteral anticoagulants to ELIQUIS (and vice versa) can be done at the next scheduled dose (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). These medicinal products should not be administered simultaneously.

Switching from vitamin K antagonist (VKA) therapy to ELIQUIS
When converting patients from vitamin K antagonist (VKA) therapy to ELIQUIS, warfarin or other VKA therapy should be discontinued and ELIQUIS started when the international normalised ratio (INR) is <2.

Switching from ELIQUIS to VKA therapy
When converting patients from ELIQUIS to VKA therapy, administration of ELIQUIS should be continued for at least 2 days after beginning VKA therapy. After 2 days of co-administration of ELIQUIS with VKA therapy, an INR should be obtained prior to the next scheduled dose of ELIQUIS. Co-administration of ELIQUIS and VKA therapy should be continued until the INR is ≥2.

Elderly
VTEt – No dose adjustment required (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

NVAF – No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction at the beginning of section 4.2).

Renal impairment
In patients with mild or moderate renal impairment, the following recommendations apply:

• for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), no dose adjustment is necessary (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• 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 above. In the absence of other criteria for dose reduction (age, body weight), no dose adjustment is necessary (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In patients with severe renal impairment (creatinine clearance 15–29 mL/min) the following recommendations apply (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

• for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) apixaban is to be used with caution;

• for the prevention of stroke and systemic embolism in patients with NVAF, patients should receive the lower dose of apixaban 2.5 mg twice daily.

In patients with creatinine clearance <15 mL/min, or in patients undergoing dialysis, there is no clinical experience therefore apixaban is not recommended in these patients (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
ELIQUIS is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).

It is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 studies. Therefore, ELIQUIS should be used with caution in this population (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Prior to initiating ELIQUIS, liver function testing should be performed.

Body weight
VTEt – No dose adjustment required (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

NVAF – No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction at the beginning of section 4.2).

Gender
No dose adjustment required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients undergoing catheter ablation (NVAF)
Patients can continue apixaban use while undergoing catheter ablation (see sections 4.3, 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

NVAF patients undergoing cardioversion
Patients can stay on apixaban while being cardioverted.

Confirmation should be sought prior to cardioversion that the patient has taken apixaban as prescribed.

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 sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of ELIQUIS in children and adolescents below age 18 have not been established. Currently available data on thromboembolism prevention are described in section 5.1 but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration

Oral use.

ELIQUIS should be swallowed with water, with or without food.

For patients who are unable to swallow whole tablets, ELIQUIS tablets may be crushed and suspended in water, or 5% glucose in water (G5W), or apple juice or mixed with apple puree and immediately administered orally (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Alternatively, ELIQUIS tablets may be crushed and suspended in 60 mL of water or G5W and immediately delivered through a nasogastric tube (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Crushed ELIQUIS tablets are stable in water, G5W, apple juice, and apple puree for up to 4 hours.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Active clinically significant bleeding.

• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• 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.

• Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2), when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).