Medicinal Products

ARANESP 15 μg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Darbepoetine alfa
laboratory: Amgen Europe BV

Injectable solution
Box of 1 pre-filled syringe 0.375 ml
All forms

Indication

- Treatment of anemia related to chronic renal failure in adults and children from 11 years.
- Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.

Dosage ARANESP 15 μg Solution for injection Box of 1 pre-filled syringe 0.375 ml

Treatment with Aranesp should be initiated by physicians experienced in the indications mentioned in the indications.
Aranesp is presented in a pre-filled syringe ready for injection. Instructions for use, handling and disposal are given in the instructions for use, handling and disposal.
TREATMENT OF ANEMIA IN CHRONIC RENAL PATIENT PATIENTS :
Aranesp can be administered subcutaneously or intravenously. The subcutaneous mode of administration is preferable in patients who are not on hemodialysis in order to preserve the peripheral veins. The purpose of the treatment is to increase the hemoglobin level above 11 g / dl (6.8 mmol / L). The precise value of the hemoglobin level to be achieved, above 11 g / dl (6.8 mmol / L), must be established for each patient. An increase in hemoglobin greater than 2 g / dl (1.25 mmol / L) over a 4-week period or a hemoglobin level greater than 14 g / dl (8.7 mmol / L) should be avoided . Clinical studies have shown that treatment responses are variable for each patient. In all cases, to start the treatment, it is necessary to follow the recommendations given below in the adult and the child, then to adapt them according to the clinical circumstances.
Treatment with Aranesp is divided into two phases - corrective phase and maintenance phase:
- Corrective phase:
. The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient [less than 1 g / dl (0.6 mmol / L) in four weeks], the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.
. If the increase in hemoglobin is greater than 2.5 g / dl (1.6 mmol / L) over the course of four weeks, reduce the dose by 25% to 50% from the previous dose, based on the level of increase. If the hemoglobin level is greater than 14 g / dl (8.7 mmol / L), discontinue treatment until hemoglobin falls below 13 g / dl (8.1 mmol / L) and then resume treatment at a dose approximately 25% lower than the previous dose. The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then, the hemoglobin level can be measured periodically.
- Maintenance phase:
. During the maintenance phase, Aranesp can continue to be administered as a single weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered. In non-dialysis patients, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks. The dose administered should be evaluated to maintain the target hemoglobin level.
. The precise value of the hemoglobin level to be achieved, above 11 g / dl (6.8 mmol / L), must be established for each patient. If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose. If hemoglobin increases by more than 2.0 g / dl (1.25 mmol / L) in 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 14 g / dl (8.7 mmol / L), discontinue treatment until hemoglobin falls below 13 g / dl (8.1 mmol / L) and then resume treatment at a dose approximately 25% lower than the previous dose.
. After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
. When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.
. Clinical trials have shown that patients receiving r-HuEPO once, twice or three times a week can benefit from Aranesp once weekly or once every two weeks. The initial dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient. When replacing r-HuEPO with Aranesp, the hemoglobin level should be monitored once a week or every two weeks and the same route of administration should be used.
TREATMENT OF SYMPTOMATIC ANEMIA IN CANCER PATIENTS :
- Aranesp should be administered subcutaneously to patients with anemia [eg. hemoglobin level <= 11 g / dl (6.8 mmol / L)].
- The recommended starting dose is 500 μg (6.75 μg / kg body weight), administered once every three weeks. If the clinical response (fatigue, hemoglobin) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.
- It is also possible to administer a weekly dose of 2.25 μg / kg body weight.
- Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.
- The hemoglobin level should not exceed 13 g / dl (8.1 mmol / L) (see section on pharmacodynamic properties).
Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% in order to maintain the optimal hemoglobin level. It may be necessary to reduce the dose again so that the hemoglobin level does not exceed 13 g / dl.
- If the hemoglobin level increases by more than 2 g / dl (1.3 mmol / L) in four weeks, the dose should be reduced by 25 to 50%.

Against indications

CONTRAINDICATED:
- Known hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
- Hypertension poorly controlled.
- Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and darbepoetine alfa relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8).
- Breast-feeding: As there is no clinical experience in breast-feeding women, it is recommended that Aranesp not be administered to women who are breastfeeding. When treatment with Aranesp is absolutely indicated, breastfeeding should be discontinued.
NOT RECOMMENDED :
Pregnancy: No clinical data are available in pregnant women. Animal studies have shown no deleterious effect on pregnancy, embryo-fetal development, parturition or postnatal development. Precautionary measures are required when prescribing pregnant women.

Aranesp side effects

The safety of Aranesp was evaluated based on a consolidated database of safety information in approximately 1800 patients with chronic renal failure treated with Aranesp for up to 24 months and 1200 treated cancer patients by Aranesp for a period of up to 4 months.
GENERALITIES :
Rare cases of potentially serious allergic reactions including dyspnea, skin rash, and urticaria have been reported with darbepoetin alfa.
INSUFFICIENT CHRONIC RENAL PATIENTS :
- Data from controlled studies involving 1578 patients treated with Aranesp and 591 patients treated with r-HuEPO showed that the overall percentage of patients who discontinued treatment due to adverse events was 2% for Aranesp and 4% for the r-HuEPO.
- Adverse effects attributable to Aranesp treatment are arterial hypertension and vascular thrombosis at the access point. However, in the consolidated database, no relationship was established between these events and the rate of hemoglobin (<12 g / dl versus > 12 g / dl) or the rate of increase of this rate (<1 g / dl, from 1 to <2 g / dl, from 2 to = 3 g / dl of hemoglobin over a period of 4 weeks).
- Injection site pain has been reported as attributable to treatment in studies where Aranesp was administered subcutaneously. This observation was more frequent than with r-HuEPO. Discomfort at the injection site was usually mild and transient and occurred most often after the first injection.
- The incidence of adverse reactions considered to be related to Aranesp treatment in controlled clinical studies is:
. Central Nervous System / Peripheral Nervous System:
Frequent (> 1%, <= 10%) : Headache.
. Cardiovascular system :
Frequent (> 1%, <= 10%) : Hypertension.
. Vascular disorders:
Frequent (> 1%, <= 10%) : Vascular thrombosis at the access point.
. Injection site:
Frequent (> 1%, <= 10%) : Pain at the injection site.
- Very rare cases of seizures have been reported in patients with chronic renal failure receiving Aranesp.
Isolated cases of erythroblastopenia due to neutralizing antibodies to erythropoietin have been reported after treatment with Aranesp. If a case of PRCA is diagnosed, treatment with Aranesp should be discontinued and treatment with another recombinant erythropoietin should not be initiated (see section 4.4).
- All other treatment-related adverse events were seen with an incidence of less than or equal to 1% (infrequent or rare), the majority of whom were mild to moderate and consistent with known associated conditions in this patient population.
CANCER PATIENTS :
- In clinical studies with subcutaneous Aranesp, the incidence of arterial hypertension and cardiovascular events was similar in cancer patients receiving placebo, r-HuEPO or Aranesp. In addition, no relationship was established between these adverse effects and the hemoglobin level (<13 versus > 13 g / dl) or the rapid increase in this rate (> 2 g / dl in 4 weeks). Clinical studies have shown a higher frequency of thromboembolic events including deep vein thrombosis and pulmonary embolism in cancer patients treated with Aranesp compared to patients receiving placebo.
- In general, adverse events reported in clinical trials with Aranesp in cancer patients receiving concomitant chemotherapy corresponded to the underlying pathology and were consistent with those associated with chemotherapy.
- The incidence of adverse reactions considered to be related to Aranesp treatment in controlled clinical studies is:
. Osteo-articular manifestation:
Frequent (> 1%, <= 10%) : Arthralgia.
. General event:
Frequent (> 1%, <= 10%) : Peripheral edema.
. Injection site:
Frequent (> 1%, <= 10%) : Pain at the injection site.
. Vascular disorders:
Frequent (> 1%, <= 10%) : Thromboembolic events.
- Pain at the injection site was the most commonly reported adverse event considered to be related to Aranesp treatment (<5%). Discomfort at the injection site was usually mild and transient.

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