Medicinal Products

ELIQUIS 5 mg

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

Coated tablet
Box of 100 blister packs of 1
All forms

Indication

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 5 mg Film-coated tablet Box of 100 blister packs of 1

Dosage

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

The recommended dosage 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 treatment of acute DVT and PE treatment is 10 mg orally 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 a prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose will be initiated following 6 months of treatment with Eliquis 5 mg twice daily or with another anticoagulant. as shown 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

Prevent recurrence of DVT and / or PE 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 you miss a dose, the patient should take Eliquis immediately and continue treatment as before with two daily doses.

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.

Patients 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 treatment of DVT, the treatment of PE and the prevention of recurrent DVT and PE (tETEV), apixaban should be used with caution;


- 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.


In the absence of clinical data in patients with creatinine clearance <15 mL / min and in dialysis patients, apixaban is not recommended in these patients (see sections Warnings and precautions for use and Pharmacokinetic properties ).

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

tETEV - No dose adjustment is necessary (see Warnings and Precautions and Pharmacokinetic Properties 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

tETEV - No dose adjustment is necessary (see Warnings and Precautions and Pharmacokinetic Properties 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 not 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

Tolerance Profile Summary

The safety of apixaban has been studied in 4 Phase III clinical trials involving more than 15, 000 patients: more than 11, 000 patients in FANV studies and more than 4, 000 patients in studies of VTE treatment. (tETEV), for a total mean exposure of 1.7 years and 221 days respectively (see section 5.1 Pharmacodynamic properties ).


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


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 by 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 available data) for FANV and tETEV respectively.


Table 2

Class of organ system

Prevention of stroke and systemic embolism in adult patients with FANV with one or more risk factors (FANV)

Treatment of the

TPV and PE, and

prevention of recurrence of DVT and PE (tETEV)

Immune system disorders

Hypersensitivity, allergic edema and anaphylaxis

Rare

-

Nervous system disorders

Cerebral hemorrhage

Rare

Rare

Eye disorders

Haemorrhage of the eye (including conjunctival haemorrhage)

Frequent

Rare

Vascular disorders

Hemorrhage, hematoma

Frequent

Frequent

Intra-abdominal hemorrhage

Rare

-

Respiratory, thoracic and mediastinal disorders

Epistaxis

Frequent

Frequent

hemoptysis

Rare

Rare

Haemorrhage of the respiratory tract

Rare

Rare

Gastrointestinal disorders

Gastrointestinal bleeding

Frequent

Frequent

Haemorrhoid hemorrhage, oral bleeding

Rare

-

haematochezia

Rare

Rare

Rectal hemorrhage, gingival hemorrhage

Frequent

Frequent

Retroperitoneal hemorrhage

Rare

-

Skin and subcutaneous tissue disorders

Skin rash

Rare

-

Renal and urinary disorders

hematuria

Frequent

Frequent

Disorders of reproductive organs and breast

He abnormal vaginal morragia, urogenital hemorrhage

Rare

Rare

General disorders and administration site conditions

Haemorrhage at the site of administration

Rare

-

investigations

Positive occult blood

Rare

Rare

Injury, poisoning and procedural complications

Contusion

Frequent

Frequent

Traumatic hemorrhage, post-procedural hemorrhage, 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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