Medicinal Products

EPREX (4000 IU / 04 ml) 10,000 IU / mL Injectable pack of 6 pre-filled syringes of 040 mL

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Epoetin alfa
laboratory: Janssen Cilag

Injectable solution
All forms

Indication

EPREX is indicated for the treatment of symptomatic anemia associated with chronic renal failure (CRF):

· In adults and children aged 1 to 18 years on hemodialysis and in adult patients on peritoneal dialysis,

· In adults with renal insufficiency who have not yet been dialyzed for the treatment of severe renal anemia with clinical symptoms in patients.

EPREX is indicated in adults treated with chemotherapy for solid tumors, malignant lymphoma or multiple myeloma, and at risk of transfusion because of their general condition (eg, cardiovascular status, pre-existing anemia at the start of chemotherapy) for the treatment of anemia and the reduction of transfusion requirements.

EPREX is indicated in adults participating in a deferred autologous transfusion program to increase autologous blood donation. Treatment should only be given to patients with moderate anemia (hemoglobin concentration between 10 and 13 g / dL [6.2 - 8.1 mmol / L], without iron deficiency) if not present or few blood saving methods when scheduled major surgery requires large amounts of blood (4 units of blood or more in women and 5 units of blood or more in men).

EPREX is indicated in adults, without iron deficiency, who is scheduled to have a major orthopedic surgical procedure, with a presumed significant risk of transfusion complications to reduce exposure to homologous blood transfusions. Use should be restricted to patients with moderate anemia (eg hemoglobin concentration between 10 and 13 g / dL) who do not have access to a deferred autologous transfusion program and are expected to moderate blood loss (900 to 1800 mL)

EPREX is indicated for the treatment of symptomatic anemia (hemoglobin concentration ≤ 10 g / dL) in adults with primary low or intermediate risk 1 myelodysplastic syndromes (MDS) with low serum erythropoietin (< 200 mU / mL).

Dosage EPREX (4000 IU / 04 ml) 10, 000 IU / mL Injectable pack of 6 pre-filled syringes of 040 mL

EPREX is indicated for the treatment of symptomatic anemia associated with chronic renal failure (CRF):

· In adults and children aged 1 to 18 years on hemodialysis and in adult patients on peritoneal dialysis,

· In adults with renal insufficiency who have not yet been dialyzed for the treatment of severe renal anemia with clinical symptoms in patients.

EPREX is indicated in adults treated with chemotherapy for solid tumors, malignant lymphoma or multiple myeloma, and at risk of transfusion because of their general condition (eg, cardiovascular status, pre-existing anemia at the start of chemotherapy) for the treatment of anemia and the reduction of transfusion requirements.

EPREX is indicated in adults participating in a deferred autologous transfusion program to increase autologous blood donation. Treatment should only be given to patients with moderate anemia (hemoglobin concentration between 10 and 13 g / dL [6.2 - 8.1 mmol / L], without iron deficiency) if not present or few blood saving methods when scheduled major surgery requires large amounts of blood (4 units of blood or more in women and 5 units of blood or more in men).

EPREX is indicated in adults, without iron deficiency, who is scheduled to have a major orthopedic surgical procedure, with a presumed significant risk of transfusion complications to reduce exposure to homologous blood transfusions. Use should be restricted to patients with moderate anemia (eg hemoglobin concentration between 10 and 13 g / dL) who do not have access to a deferred autologous transfusion program and are expected to moderate blood loss (900 to 1800 mL)

EPREX is indicated for the treatment of symptomatic anemia (hemoglobin concentration ≤ 10 g / dL) in adults with primary low or intermediate risk 1 myelodysplastic syndromes (MDS) with low serum erythropoietin (< 200 mU / mL).

Against indications

· Hypersensitivity to the active substance or to any of the excipients.

· Patients who have developed PRCA following treatment with erythropoietin should not be treated with EPREX or any other erythropoietin (see Warnings and Precautions for Use - Pure Red Cell Aplasia).

· Uncontrolled hypertension.

· All contraindications associated with a deferred autologous transfusion program should be respected in patients receiving EPREX during such a program.

· The use of EPREX, in patients requiring major programmed orthopedic surgery and not participating in a delayed autologous transfusion program, is contraindicated in patients with severe coronary vascular disease, peripheral arteries, carotid artery, or cerebral, including in patients with a recent history of myocardial infarction or stroke.

· Surgery patients who, for whatever reason, can not receive appropriate antithrombotic prophylaxis.

Eprex side effects (4000 Ui / 0.4 Ml)

Tolerance Profile Summary

The most common side effect with epoetin alfa is a dose-related increase in blood pressure or worsening of pre-existing hypertension. Blood pressure monitoring should be performed, particularly at the start of treatment (see Warnings and Precautions ).

The most common adverse events in clinical studies with epoetin alfa are diarrhea, nausea, vomiting, pyrexia and headache. An influenza-like illness may occur, especially at the beginning of treatment.

Airway congestion, including upper respiratory congestion events, nasal congestion, and nasopharyngitis, have been reported in studies in adult patients with renal insufficiency who have not yet undergone dialysis with prolonged administration intervals.

An increased incidence of thrombotic vascular events (EVT) has been observed in patients receiving ESAs (see Warnings and Precautions ).

Tabulated list of adverse effects

From a total of 3417 subjects who participated in 25 randomized, double-blind, placebo-controlled or standard-of-care studies, the overall safety profile of EPREX was evaluated in 2094 anemic subjects. Included were 228 subjects with CKD treated with epoetin alfa in 4 studies conducted in chronic renal failure (2 predialysis studies [N = 131 exposed CKD subjects] and 2 dialysis studies [N = 97 exposed CKD subjects]); 1, 404 cancer patients exposed in 16 studies conducted in chemically-induced anemia, 147 subjects exposed in 2 autologous deferred transfusion program studies, 213 subjects exposed in 1 perioperative study and 102 subjects exposed in 2 studies in the MDS. Adverse events reported in ≥ 1% of subjects treated with epoetin alfa in these studies are presented in the table below.

Frequencies are defined as follows: very common (≥1 / 10); frequent (≥1 / 100, <1/10); uncommon (≥1 / 1, 000, <1/100); rare (≥1 / 10, 000, <1/1000); very rare (<1 / 10, 000); indeterminate frequency (can not be estimated based on available data).

Classes of organ systems

Undesirable effect

Frequency

Blood and lymphatic system disorders

Erythroblastopenia 3

thrombocythemia

Rare

Metabolism and nutrition disorders

Hyperkalemia 1

Rare

Immune system disorder

Hypersensitivity 3

Rare

Anaphylactic reaction 3

Rare

Affection of the nervous system

headaches

Frequent

convulsions

Rare

Vascular disorders

Hypertension, Venous and Arterial Thrombosis 2

Frequent

Acute hypertension crisis 3

Not known frequency

Respiratory, thoracic and mediastinal disorders

Cough

Frequent

Congestion of the respiratory tract

Rare

Gastrointestinal disorders

Diarrhea, Nausea, Vomiting

Very common

Affections of the skin and connective tissue

rash

Frequent

Urticaria 3

Rare

Angioneurotic edema 3

Not known frequency

Musculoskeletal and connective tissue disorders

Arthralgia, Bone pain, Myalgia, Painful extremities

Frequent

Congenital, familial and genetic disorders

Acute Porphyria 3

Rare

General disorders and administration site conditions

Fever

Very common

Chills, Influenza, Injection site reaction, Peripheral edema

Frequent

Inefficient medication 3

Not known frequency

investigations

Presence of anti-erythropoietin antibodies

Rare

1 Frequent in dialysis.

2 Includes arterial and venous events, fatal and nonfatal, such as deep vein thrombosis, pulmonary embolism, retinal thrombosis, arterial thrombosis (including myocardial infarction), stroke (including cerebral infarction and cerebral hemorrhage) transient ischemic attacks and thrombosis of an arteriovenous bypass (including dialysis fistula) and thrombosis in aneurysms of arteriovenous shunts.

3 Presented in the sub-section below and / or in the Warnings and Precautions section .

Descriptions of particular adverse effects

Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions and angioneurotic edema have been reported.

Hypertensive seizures with encephalopathy and seizures, requiring immediate medical attention and intensive care management, have also occurred during treatment with epoetin alfa in patients whose blood pressure was previously normal or low. Particular attention should be paid to violent pseudo-migraine headaches of sudden onset as a possible alarm signal (see section Warnings and precautions for use ).

Antibody-mediated PRCA has been reported very rarely in less than one case per 10, 000 patient-years after months or years of treatment with EPREX (see Warnings and Precautions section ).

Adult patients with low or intermediate risk MDS 1

In the randomized, double-blind, placebo-controlled, multicenter study, 4 (4.7%) subjects presented with EVT (sudden death, ischemic stroke, embolism, and phlebitis). All EVT occurred in the epoetin alfa group and in the first 24 weeks of the study. Three were confirmed as EVT and for the remaining case (sudden death) the thromboembolic event was not confirmed. Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).

Pediatric population with chronic renal failure and hemodialysis

Exposure in chronic renal failure children with hemodialysis in clinical trials and post-marketing is limited. No adverse effects specific to the pediatric population not mentioned in the table above, or inconsistent with the underlying pathology, have been reported in this population.

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 declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

ANSM alert of 01/09/2017:

- Severe skin reactions (SCAR) have been reported in patients treated with recombinant human epoetins. Among these reactions, cases of Stevens-Johnson syndrome (SSJ) and Lyell syndrome (SL) (toxic epidermal necrolysis) have been reported, some of which have been fatal.

- Upon initiation of recombinant human epoetin, patients should be advised that the following signs and symptoms may be suggestive of severe skin reactions: extensive rash with redness, bubbles in the skin and oral mucosa, eyes, nose, throat, or genitals, preceded by flu-like symptoms including fever, fatigue, muscle and joint pain. This often leads to exfoliation and peeling of the affected skin similar to a severe burn.

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