Medicinal Products

EPREX 1000 IU / 0.5 ml

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

Injectable solution
Box of 6 pre-filled syringes of 0.5 ml
All forms

Indication

- Treatment of anemia secondary to chronic renal failure in children and adult patients with hemodialysis and adult patients on peritoneal dialysis.
- Treatment of severe renal anemia with clinical symptoms in adult patients with renal insufficiency who have not yet been dialyzed.
- Treatment of anemia and reduction of transfusion requirements in adult patients treated with chemotherapy for solid tumors, malignant lymphomas or multiple myeloma and at risk of transfusion due to their general condition (eg cardiovascular status, pre-existing anemia). start of chemotherapy).
- EPREX can be used to increase autologous blood donation in patients participating in a deferred autologous transfusion program. Use in this indication should take into account the increased risk of thromboembolic events. The treatment is indicated in patients with moderate anemia (Hb: 10-13 g / dl or 6.21-8.07 mmol / L) and without iron deficiency if there are no or few methods of saving blood when important scheduled surgery requires large amounts of blood (4 units of blood or more in women and 5 units of blood or more in men).
- EPREX may be used to reduce exposure to homologous blood transfusions in non-iron deficient adult patients undergoing major scheduled orthopedic surgery, with a presumed significant risk of transfusion complications. Use should be restricted to patients with moderate anemia (eg, Hb 10-13 g / dl) who do not have access to a delayed autologous sampling program and who are expected to experience moderate blood loss ( 900 to 1800 ml).
Good Blood Management Practices should always be applied in the surgical setting .

Dosage EPREX 1000 IU / 0.5 ml Solution for injection Box of 6 0.5 ml pre-filled syringes

Manual :
As with any injectable product, check for suspended particles and discoloration.
a) Intravenous injection : in at least 1 to 5 minutes, depending on the total dose.
In hemodialysis patients, a bolus injection may be performed during the dialysis session in the appropriate injection site located at the venous return of the dialysis line. Another possibility would be to inject after dialysis into the fistula needle, followed by rinsing with 10 ml of isotonic saline to ensure proper passage of the product through the circulation.
A slower injection is preferable in patients who have had flu-like symptoms.
Do not administer by intravenous infusion or in admixture with other drugs.
b) Subcutaneous injection : A maximum volume of 1 ml per injection site should generally not be exceeded. In case of larger volume, use more than one injection site.
Injections are done at the level of the limbs or the anterior abdominal wall.
- Patients with chronic renal failure:
. In patients with chronic renal failure, the product should only be administered intravenously (see section contraindications and warnings and precautions for use - PRCA).
. The target hemoglobin level is 10 to 12 g / dl (6.2-7.5 mmol / L) except for children for whom the hemoglobin level should be between 9.5 and 11 g / dl ( 5.9-6.8 mmol / L).
. In patients with chronic renal failure and clinical signs of myocardial ischemia or congestive heart failure, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target range.
The state of iron stores should be assessed before and during treatment and iron supplementation should be given when needed. In addition, before starting treatment with epoetin alfa, other causes of anemia, such as B12 or folate deficiency, must be eliminated. Failure to respond to treatment with epoetin alfa should seek the causes. These can be: deficits of iron, folate or vitamin B12; aluminum intoxication; intercurrent infections; inflammatory syndromes or trauma; occult bleeding; hemolysis and medullary fibrosis of any origin.
- Adult patients on hemodialysis:
In adult patients on hemodialysis, the product should be administered only intravenously (see section contraindications and warnings and precautions for use - PRCA).
The treatment is divided into two phases:
. Corrective phase :
50 IU / kg 3 times a week, IV.
If dose adjustment is necessary, it is recommended to proceed in steps of at least 4 weeks. At each level, the recommended dose increase or decrease is 25 IU / kg 3 times a week.
. Maintenance phase :
The dosage is adjusted to maintain hemoglobin at the desired level: Hb between 10 and 12 g / dl (6.2-7.5 mmol / L).
The recommended total dose per week is between 75 and 300 IU / kg.
Available clinical data indicate that patients with very low baseline hemoglobin (<6 g / dL or 3.75 mmol / L) may require higher maintenance doses than those with anemia. initial dose is less severe (greater than 8 g / dl or 5 mmol / L).
- Children on hemodialysis:
In children on hemodialysis, the product should be administered only intravenously (see sections contraindications and warnings and precautions for use - PRCA).
The treatment is divided into two phases:
. Corrective phase :
50 IU / kg 3 times a week intravenously. If dose adjustment is necessary, it is recommended to proceed in increments of 25 IU / kg 3 times weekly, with an interval of at least 4 weeks between each adjustment, until the desired end is reached.
. Maintenance phase :
The dosage is adjusted to maintain hemoglobin at the desired level: Hb between 9.5 and 11 g / dl (5.9-6.8 mmol / L).
Generally children under 30 kg require higher maintenance doses than those over 30 kg and adults. For example, the following maintenance doses were used in clinical trials after 6 months of treatment:
Dose (IU / kg 3 times a week) .
Weight: Medium / Usual maintenance dose .
less than 10 kg: 100 / 75-150.
10-30 kg: 75 / 60-150.
greater than 30 kg: 33 / 30-100.
Available clinical data suggest that patients with very low initial hemoglobin levels (less than 6.8 g / dl or 4.25 mmol / L) may require higher maintenance doses than those initial hemoglobin is higher (greater than 6.8 g / dl or 4.25 mmol / L).
- Adult patients with renal insufficiency who have not yet been dialyzed:
EPREX should only be administered intravenously (see sections contraindications and warnings and precautions for use - Pure Red Cell Aplasia).
The treatment is divided into two phases:
. Corrective phase :
The initial dose is 50 IU / kg 3 times a week, followed if necessary by an increase of 25 IU / kg (3 times a week) until the desired goal is reached (at least 4 weeks) ).
. Maintenance phase :
The dosage is adjusted to maintain hemoglobin at the desired level: Hemoglobin between 10 and 12 g / dl (6.2-7.5 mmol / L) (maintenance dose between 17 and 33 IU / kg 3 times weekly) .
The maximum dosage should not exceed 200 IU / kg 3 times a week.
- Adult patients on peritoneal dialysis:
EPREX should only be administered intravenously (see sections contraindications and warnings and precautions for use - Pure Red Cell Aplasia).
The treatment is divided into two phases:
. Corrective phase :
The initial dosage is 50 IU / kg twice a week.
. Maintenance phase :
The dosage is adjusted to maintain hemoglobin at the desired level: Hb between 10-12 g / dl (6.2-7.5 mmol / L) (maintenance dose between 25 and 50 IU / kg twice weekly in 2 identical injections).
- Adult cancer patients receiving chemotherapy:
. The subcutaneous route must be the route used.
. Epoetin alfa should be administered to patients with anemia (hemoglobin less than 10.5 g / dl or 6.5 mmol / L, as an indication).
. The hemoglobin level to be reached is about 12 g / dl (7.5 mmol / L).
. Epoetin alfa should continue to be administered for one month after the end of chemotherapy.
. The initial dose is 150 IU / kg administered subcutaneously 3 times a week. Alternatively, EPREX can be administered subcutaneously at the initial dose of 450 IU / kg once a week. If hemoglobin has increased by at least 1 g / dl (0.62 mmol / L), or if reticulocytes have increased by at least 40, 000 / μl from baseline after 4 weeks of treatment, the dose should be stay at 150 IU / kg 3 times a week or 450 IU / kg once a week. If the increase in hemoglobin is less than 1 g / dl (less than 0.62 mmol / L) and the reticulocytes have increased by less than 40, 000 / μl from baseline, increase the dose to 300 IU / kg 3 times a week. If after 4 additional weeks of treatment at 300 IU / kg 3 times weekly, hemoglobin increased by at least 1 g / dl (at least 0.62 mmol / L) or reticulocytes increased by at least 40, 000 / μl, the dose of 300 IU / kg 3 times a week should be maintained. However, if hemoglobin increased by less than 1 g / dl (less than 0.62 mmol / L) and reticulocytes increased by less than 40, 000 / μL from baseline, the response is unlikely and treatment should be stopped.
. Adaptation of the doses :
An increase in hemoglobin of more than 2 g / dl (1.25 mmol / L) per month or a hemoglobin level greater than 13 g / dl (8.1 mmol / L) must be avoided.
If hemoglobin increases by more than 2 g / dl (1.25 mmol / L) per month or if it is close to 12 g / dl (7.4 mmol), reduce the dose of epoetin alfa d approximately 25% -50% depending on the level of increase in hemoglobin level.
If the hemoglobin level exceeds 13 g / dl (8.1 mmol / L), discontinue treatment until the level falls below 12 g / dl (7.4 mmol / L) and resume treatment with epoetin alfa at a dose 25% lower than the previous dose.
- Adult patients in surgery participating in a delayed autologous sampling program:
. The intravenous route should be used. When taking blood samples, epoetin alfa should be given after the blood collection is complete.
. The dosage of epoetin alfa in patients with moderate anemia (hematocrit between 33 and 39%) who must give at least 4 units of blood, is 600 IU / kg 2 times a week for 3 weeks before the operation. Using this dosage, it was possible to obtain at least 4 units of blood in 81% of patients treated with epoetin alfa compared to 37% of patients in the placebo group. Epoetin alfa reduced the risk of homologous blood exposure by 50% compared to patients not receiving epoetin alfa.
. All patients treated with epoetin alfa should receive appropriate iron supplementation (eg 200 mg per day of oral iron) for the duration of treatment with epoetin alfa. Iron supplementation should be started as early as possible, or even weeks before the start of autologous specimens, in order to reach significant iron stores before beginning treatment with epoetin alfa.
- Adult patients scheduled for major scheduled orthopedic surgery:
. The subcutaneous route must be used.
. The recommended dose is 600 IU / kg epoetin alfa, once a week for 3 weeks (-21, -14, -7 days) prior to surgery and the day of surgery. If the intervention period is to be reduced for medical reasons less than 3 weeks, epoetin alfa should be administered at a dose of 300 IU / kg daily, for 10 consecutive days prior to surgery, the day of the intervention and during the 4 days following the intervention. During the preoperative biological test, if the hemoglobin level reaches 15 g / dL or more, the administration of epoetin alfa should be discontinued and the subsequent doses initially planned should not be administered.
- It must be ensured that patients are not deficient in iron at the start of treatment.
- All patients treated with epoetin alfa should receive appropriate iron supplementation (eg 200 mg / day oral iron) for the duration of treatment with epoetin alfa. If possible, iron supplementation should be started before treatment with epoetin alfa to provide adequate iron stores.

Against indications

CONTRAINDICATED:
- Hypersensitivity to the active substance or to any of the excipients.
- The subcutaneous route is contraindicated only in patients with chronic renal failure (see paragraph warnings and precautions for use - Pure red cell aplasia and paragraph adverse effects).
- Patients who have developed PRCA following treatment with erythropoietin should not be treated with EPREX or any other erythropoietin (see section on warnings and precautions for use - Pure red cell aplasia).
- Uncontrolled hypertension.
- All contraindications associated with a delayed autologous sampling program should be respected in patients receiving epoetin alfa during such a program.
- The use of epoetin alfa in patients scheduled for major scheduled orthopedic surgery who do not participate in a delayed autologous sampling program is contraindicated:
. in patients with severe coronary artery disease, carotid artery disease, peripheral arteries, or cerebral artery disease, including in patients with a recent history of myocardial infarction or stroke.
. in patients who, for whatever reason, can not receive appropriate antithrombotic prophylaxis.
Do not administer by intravenous infusion.
NOT RECOMMENDED :
Pregnancy and breast-feeding: There are no specific and controlled studies in pregnant women. Studies in animals have shown a toxic effect during reproduction. Therefore: in patients with chronic renal failure, epoetin alfa should only be used during pregnancy if the expected benefit justifies the potential risk to the fetus; the use of epoetin alfa is not recommended for pregnant or breastfeeding patients who are participating in a delayed autologous bleeding program prior to surgery.

Eprex side effects

- Generalities:
. Non-specific cutaneous rashes have been described when using epoetin alfa.
. Flu-like symptoms such as headache, joint pain, feeling weak, dizziness and asthenia can occur, especially at the beginning of treatment.
. The occurrence of thrombocytosis is rare (see precautions for use).
. Thrombotic / vascular events, such as myocardial ischemia, myocardial infarction, stroke (cerebral hemorrhage and cerebral infarction), transient ischemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary embolism, aneurysms, retinal thrombosis, and thrombosis of a Artificial kidneys have been reported in patients receiving erythropoietin including in patients receiving EPREX.
. Hypersensitivity reactions have been reported rarely with epoetin alfa including isolated cases of angioedema and anaphylactic reactions.
- Adult patients and children on hemodialysis, adult patients on peritoneal dialysis and adult patients with chronic renal failure who have not yet been dialyzed:
. The most common side effect during treatment with epoetin alfa is a dose-related increase in blood pressure or worsening of pre-existing hypertension. This increase in blood pressure can be treated medically. In addition, blood pressure monitoring is recommended especially at the beginning of treatment.
The following reactions may also occur in some normal or hypotensive patients: hypertensive crisis with encephalopathy-like symptoms (ie headache and confusion) and generalized tonic-clonic seizures, requiring immediate medical treatment and treatment. in charge of intensive care. Headaches such as violent migraines and sudden onset can be an alarm signal.
. Fistula can be thrombosed, especially in patients who have a tendency to hypotension or who have complications in their arteriovenous fistula (ie stenosis, aneurysms, etc.). Early revision of the fistula with antithrombotic prophylaxis by administration of acetylsalicylic acid, for example, is advisable in such patients.
. Rare cases of PRCA have been reported in patients with chronic renal failure treated with EPREX or other erythropoietins for several months or years. In most of these patients, anti-erythropoietin antibodies have been observed (see section contraindications and warnings and precautions for use - Pure red cell aplasia).
- Anemic cancer patients treated with chemotherapy:
. Hypertension can occur in patients treated with epoetin alfa. As a result, hemoglobin levels and blood pressure should be closely monitored.
. An increased incidence of thrombotic vascular events (see Warnings and Precautions and Adverse Reactions - General sections) has been observed in patients treated with erythropoietin.
. In a study conducted in women with metastatic breast cancer performed to determine whether treatment with erythropoietin beyond the correction of anemia, could improve treatment outcomes, overall mortality rate and mortality rates attributed the progression of the disease and the occurrence of thromboembolic events were all higher in patients treated with epoetin alfa than in patients in the placebo group.
- Patients participating in a delayed autologous sampling program before surgery:
Regardless of treatment with epoetin alfa, thrombovascular accidents can occur as a result of iterative blood sampling in patients with underlying cardiovascular disease and undergoing surgery. For this reason, it is advisable for these patients to systematically compensate for the volume taken.
- Patients to benefit from major scheduled orthopedic surgery:
. In patients scheduled for major scheduled orthopedic surgery and with an initial hemoglobin level of 10 to 13 g / dl, the incidence of thromboembolic events (most of which were deep vein thromboses), in the overall clinical trials, was found to be similar in the different groups treated with epoetin alfa and in the placebo group. Nevertheless, clinical experience is limited.
. In addition, in patients with an initial hemoglobin greater than 13 g / dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thromboembolic events is not excluded.

Popular Posts

Category Medicinal Products, Next Article