Medicinal Products

ELIQUIS 2.5 mg

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Apixaban
laboratory: Pfizer

Coated tablet
Box of 60 platelets precut of 1
All forms

Indication

Prevention of venous thromboembolic events (VTE) in adult patients who have undergone programmed surgery for total hip or knee arthroplasty.


Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (FANV) with one or more risk factors such as: history of stroke or stroke transient ischemic attack (TIA); age ≥ 75 years; high blood pressure; diabetes; 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 Warnings and Precautions for Patients with a hemodynamically unstable EP).

Dosage ELIQUIS 2.5 mg Film-coated tablet Box of 60 Pre-cut wafers of 1

Dosage


ETEV Prevention (pETEV): Total Hip or Knee Replacement Surgery The recommended dose of Eliquis is two oral doses of 2.5 mg daily. The first dose should be taken 12 to 24 hours after surgery.


The doctor will determine the time of administration within 12 to 24 hours after the surgical procedure, depending on the potential benefits on the prevention of venous thromboembolic events and the risk of post-surgical bleeding from treatment. anticoagulant more or less early.


In patients undergoing total hip replacement surgery The recommended duration of treatment is 32 to 38 days.


In patients undergoing total knee arthroplasty surgery
The recommended duration of treatment is 10 to 14 days.

Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (FANV)

The recommended dose of Eliquis is two oral doses of 5 mg daily.

Dose reduction


The recommended dose of Eliquis is 2.5 mg orally twice daily in FANV patients with at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1, 5 mg / dL (133 micromol / L).


Treatment must be continued in the long term.

Treatment of DVT, Treatment of PE and Prevention of Recurrent DVT and PE (tETEV) The recommended dose of Eliquis for the treatment of acute DVT and PE treatment is 10 mg per day Oral twice daily for the first 7 days followed by 5 mg orally twice daily. According to current recommendations, a short treatment duration (at least 3 months) will be based on transient risk factors (eg recent surgery, trauma, immobilization).


The recommended dose of Eliquis for the prevention of recurrent DVT and PE is 2.5 mg orally twice daily. When prevention of DVT and PE recurrence is indicated, the 2.5 mg twice daily dose will be initiated following 6 months of treatment with Eliquis 5 mg twice daily or by another anticoagulant, as indicated in Table 1 below (see also section Pharmacodynamic properties ).


Table 1:

Diagram of administration

Maximum daily dose

Treatment of DVT or PE

10 mg twice daily for the first 7 days

20 mg

followed by 5 mg twice daily

10 mg

Prevention of DVT and / or PE recurrence after 6 months of treatment for DVT or PE

2.5 mg twice daily

5 mg

The duration of the overall treatment will be personalized after a rigorous evaluation of the benefit of the treatment in relation to the risk of haemorrhage (see section Warnings and Precautions for Use ).

Missed a dose

If a dose is missed, the patient should take Eliquis immediately and continue treatment with 2 doses daily as before.

Treatment relay

The switch from parenteral anticoagulant therapy to Eliquis (and vice versa) can be done at the scheduled time of the next dose (see section 4.5 Interactions with other medicinal products and other forms of interaction ). These treatments should not be administered simultaneously.

Relay of an anti-vitamin K (AVK) by Eliquis

Treatment with warfarin or another VKA should be discontinued first. Treatment with Eliquis can begin as soon as the INR (international normalized ratio) is <2.0.

Relay of Eliquis by an AVK

Eliquis treatment should be continued for at least 2 days after initiation of AVK therapy. After 2 days of co-administration of Eliquis and AVK, the INR should be measured before the next dose of Eliquis. Continue co-administration of Eliquis and AVK until the INR is ≥ 2.0.

Patient with renal insufficiency

No dose adjustment is necessary in patients with mild or moderate renal impairment (see section 5.2 ).


In patients with severe renal impairment (creatinine clearance 15 to 29 mL / min), the following recommendations apply (see sections Warnings and Precautions and Pharmacokinetic Properties ):

- for the prevention of VTE in programmed surgery for a total hip or knee replacement (pETEV), for the treatment of DVT, the treatment of PE and the prevention of recurrent DVT and PE ( tETEV), apixaban will be used with care;

- For the prevention of stroke and systemic embolism in patients with FANV, patients should receive the low dose of apixaban 2.5 mg twice daily.

Patients with serum creatinine ≥ 1.5 mg / dL (133 micromol / L) ≥ 80 years of age or body weight ≤ 60 kg should also receive the low dose of apixaban 2.5 mg two times a day.


There is no clinical experience in patients with creatinine clearance <15 mL / min nor in dialysis patients, so apixaban is not recommended (see Warnings and Precautions and PK) sections. .

Patients with hepatic impairment

Eliquis is contraindicated in patients with hepatic impairment associated with coagulopathy and clinically significant bleeding risk (see section 4.3 ).


It is not recommended in patients with severe hepatic impairment (see Warnings and Precautions and Pharmacokinetic Properties sections).


It should be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B). No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see Warnings and Precautions and PK ) sections.


Patients with elevated liver enzymes (ALT / ASAT> 2 x LNS) or total bilirubin ≥ 1.5 x LNS were excluded from clinical studies. Therefore, Eliquis should be used with caution in this population (see sections Warnings and Precautions for Use and Pharmacokinetic Properties ). Before initiation of treatment with Eliquis, liver function should be evaluated.

Body weight

pETEV and tETEV - No dosage adjustment is required (see Warnings and Precautions and PK) sections. FANV - No dose adjustment is required unless the dose reduction criteria are met (see Dose Reduction at the beginning of section Dosage and Method of Administration ).

Sex

No dosage adjustment is required (see section 5.2 ).

Elderly

pETEV and tETEV - No dosage adjustment is required (see Warnings and Precautions and PK) sections. FANV - No dose adjustment is required unless the dose reduction criteria are present (see Dose Reduction at the beginning of Dosage and Method of Administration ).

Cardioversion (FANV)

Patients may remain on apixaban when they are exposed to cardioversion.

Pediatric population

The safety and effectiveness of Eliquis in children and adolescents under 18 years of age

have been established.

No data available.


Administration mode
Oral way.

Eliquis must be swallowed with water, during or outside meals.

Against indications

• Hypersensitivity to the active substance or to any of the excipients listed under Composition .

• Clinically significant progressive bleeding.

• Hepatic impairment associated with coagulopathy and clinically significant bleeding risk (see section 5.2 Pharmacokinetic properties ).

• Lesion or condition, if considered a significant risk factor for major bleeding. This may include: active or recent gastrointestinal ulcer, presence of malignancy at high risk of bleeding, recent brain or spinal cord injury, recent brain or spinal or ophthalmologic surgery, recent intracranial hemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysm or major intraspinal or intracerebral vascular abnormalities.

• Concomitant treatment with other anticoagulants, eg unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivative (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.), except in the specific cases of an anticoagulant treatment relay (see Dosage and method of administration section ) or when the UFH is administered in doses necessary to maintain the permeability of a venous catheter or central arterial (see section Interactions with other medicinal products and other forms of interaction ).

Eliquis side effects

Summary of the security profile

The safety of apixaban has been studied in 7 Phase III clinical studies involving more than 21, 000 patients: more than 5, 000 patients in pETEV studies, more than 11, 000 patients in FANV studies, and more of 4000 patients in studies of the treatment of ETEV (tETEV) for a mean total exposure of 20 days, 1.7 years and 221 days respectively (see section 5.1 ).


Common side effects were hemorrhage, contusion, epistaxis, and hematoma (see Table 2 for adverse event profile and frequency by indication).


In studies of VTE prevention, a total of 11% of patients treated with 2.5 mg apixaban twice daily had adverse effects. The overall incidence of hemorrhagic adverse events with apixaban was 10% in the apixaban vs enoxaparin studies.


In studies in patients with FANV, the overall incidence of hemorrhagic adverse events with apixaban was 24.3% in the apixaban vs warfarin study, and 9.6% in the apixaban vs aspirin study. In the apixaban vs warfarin study, the incidence of major gastrointestinal bleeding defined according to the ISTH criteria (including upper GI, lower GI and rectal bleeding) under apixaban was 0.76% per year. The incidence of major intraocular bleeding defined according to the ISTH criteria under apixaban was 0.18% per year.


In the tETEV studies, the overall incidence of hemorrhagic adverse events with apixaban was 15.6% in the apixaban vs enoxaparin / warfarin study, and 13.3% in the apixaban vs placebo study (see section 5.1 ). .


Table of adverse effects

Table 2 presents the adverse effects by system organ class and frequency using the following convention: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10 000 to <1/1000)); very rare (<1 / 10, 000); indeterminate (can not be estimated from the available data) for pETEV, FANV and tETEV respectively.


Table 2

Class of organ systems

Prevent VTE in adult patients who have undergone total hip or knee replacement surgery (pETEV)

Prevention of stroke and systemic embolism in

adult patients with FANV presenting

one or more risk factors (FANV)

Treatment of DVT and PE, and prevention of recurrence of DVT and PE (tETEV)

Blood and lymphatic system disorders

Anemia

Frequent

-

-

thrombocytopenia

Rare

-

-

Immune system disorders

Hypersensitivity, allergic edema and anaphylaxis

Rare

Rare

-

Nervous system disorders

Cerebral hemorrhage

-

Rare

Rare

Eye disorders

Haemorrhage of the eye (including conjunctival haemorrhage)

Rare

Frequent

Rare

Vascular disorders

Haemorrhage, hematoma

Frequent

Frequent

Frequent

Hypotension (including procedural hypotension)

Rare

-

-

Intra-abdominal hemorrhage

-

Rare

-

Respiratory, thoracic and mediastinal disorders

Epistaxis

Rare

Frequent

Frequent

hemoptysis

Rare

Rare

Rare

Haemorrhage of the respiratory tract

-

Rare

Rare

Gastrointestinal disorders

nausea

Frequent

-

-

Gastrointestinal bleeding

Rare

Frequent

Frequent

Haemorrhoidal haemorrhage, oral bleeding

-

Rare

-

haematochezia

Rare

Rare

Rare

Rectal hemorrhage, gingival bleeding

Rare

Frequent

Frequent

Retroperitoneal hemorrhage

-

Rare

-

Hepatobiliary disorders

Elimination of transaminases, elevation of aspartate aminotransferase, elevation of gamma-glutamyltransferase, abnormal liver function tests, elevation of blood alkaline phosphatase, elevation of blood bilirubin

Rare

-

-

Skin and subcutaneous tissue disorders

Skin rash

-

Rare

-

Musculoskeletal and systemic disorders

Muscle hemorrhage

Rare

-

-

Renal and urinary disorders

hematuria

Rare

Frequent

Frequent

Disorders of reproductive organs and breast

Vaginal haemorrhage abnormal, urogenital hemorrhage

-

Rare

Rare
General disorders and administration site conditions

Horror rages at the administration site

-

Rare

-

investigations

Positive occult blood

-

Rare

Rare

Injury, poisoning and procedural complications

Contusion

Frequent

Frequent

Frequent

Post procedural haemorrhage (including post-procedural hematoma, wound hemorrhage, hematoma at the venipuncture site and haemorrhage at the catheter insertion site), wound secretion, haemorrhage at the site of the incision (including hematoma at the site of the incision), operative bleeding

Rare

-

-

Traumatic hemorrhage, postprocedural haemorrhage, haemorrhage at the incision site

-

Rare

Rare

The use of Eliquis may be associated with an increased risk of occult or externalized bleeding from any tissue or organ, which may result in post-hemorrhagic anemia. Signs, symptoms, and severity will vary depending on the location and extent or extent of bleeding (see Warnings and Precautions and Pharmacodynamic Properties section).


Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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