Medicinal Products

EPORATIO 30,000 IU / 1 ml

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Epoetin theta
laboratory: Ratiopharm Gmbh

Injectable solution
Box of 4 pre-filled syringes of 1 ml
All forms

Indication

- Treatment of symptomatic anemia associated with chronic renal failure in adults.

- Treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies treated with chemotherapy.

Dosage EPORATIO 30 000 IU / 1 ml Solution for injection Box of 4 pre-filled syringes of 1 ml

Specials

Treatment with epoetin theta should be initiated under the supervision of physicians experienced in the management of patients with the above indications.

Routes of administration

The solution can be administered subcutaneously (SC) or intravenously (IV). The subcutaneous route is preferable in non-hemodialysis patients, to preserve the peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. Epoetin theta should be administered subcutaneously in cancer patients with non-myeloid malignancies treated with chemotherapy.

Dosage

Treatment of symptomatic anemia associated with chronic renal failure. The symptoms and sequelae of anemia may vary with age, gender and overall severity of the disease, a case-by-case assessment of the clinical course and status of the patient by a physician is necessary. Epoetin theta should be administered subcutaneously or intravenously to achieve a hemoglobin level of 12 g / dl or less (7.45 mmol / l).

Due to intra-patient variability, the observed hemoglobin level may sometimes be higher or lower than that desired in a given patient. The variability of hemoglobin should be managed by a dosage adjustment to maintain the target hemoglobin level between 10 g / dl (6.21 mmol / l) and 12 g / dl (7.45 mmol / l). Hemoglobin levels greater than 12 g / dl (7.45 mmol / l) should be avoided over a prolonged period; recommendations for appropriate dosage adjustment when the observed hemoglobin level is greater than 12 g / dl (7.45 mmol / l) are described below.

Any increase in hemoglobin by more than 2 g / dl (1.24 mmol / l) over a four-week period should be avoided. If the increase in hemoglobin is greater than 2 g / dl (1.24 mmol / l) in 4 weeks or if the hemoglobin level exceeds 12 g / dl (7.45 mmol / l), the dose must be reduced by 25 to 50%. It is recommended to monitor the hemoglobin level every two weeks until the levels stabilize, then periodically thereafter. If the hemoglobin level continues to increase, treatment should be discontinued until the hemoglobin level goes down, then the treatment should be resumed at a reduced dose of approximately 25% over the previously administered dose. .

In the presence of pre-existing hypertension or cardiovascular, cerebrovascular or peripheral vascular diseases, the increase in hemoglobin and the hemoglobin value to be achieved must be determined individually according to the clinical picture.

Treatment with epoetin theta is divided into two phases.

Correction phase

Subcutaneous administration: The starting dose is 20 IU / kg body weight 3 times a week. The dose may be increased after 4 weeks to 40 IU / kg, 3 times a week, if the increase in hemoglobin is not satisfactory (<1 g / dl [0.62 mmol / l]). 4 weeks). Additional increases of 25% of the previous dose may be considered every month until the target value of hemoglobin is reached.

Intravenous administration: The initial dose is 40 IU / kg body weight 3 times a week. The dose may be increased after 4 weeks to 80 IU / kg, 3 times a week, and by further increments of 25% of the previous dose to one month apart, if necessary.

For both routes of administration, the maximum dose should not exceed 700 IU / kg body weight per week.

Maintenance phase

The dosage should be adjusted to maintain, if necessary, the individual target hemoglobin level between 10 g / dl (6.21 mmol / l) and 12 g / dl (7.45 mmol / l), with a maximum 12 g / dl (7.45 mmol / l). If dose adjustment is necessary to maintain the desired hemoglobin level, dose adjustments of approximately 25% of the dose are recommended.

Subcutaneous Administration: The weekly dose may be given as one injection per week or as 3 injections per week.

Intravenous Administration: Stable patients with administration three times a week may switch to a frequency of twice a week.

If the frequency of administration is changed, the hemoglobin level should be closely monitored and dosage adjustments may be necessary.

The maximum dose should not exceed 700 IU / kg body weight per week.

If epoetin theta is substituted for another epoetin, the hemoglobin level should be closely monitored and the same route of administration should be used.

Patients should be closely monitored to ensure that they receive the lowest approved dose of epoetin theta to appropriately control the symptoms of anemia.

Symptomatic anemia associated with chemotherapy given in non-myeloid cancers.

Epoetin theta should be administered subcutaneously in anemic patients (eg, hemoglobin level ≤ 10 g / dl [6.21 mmol / l]). The symptoms and sequelae of anemia may vary with age, gender, and overall severity of the disease; a careful assessment of the clinical course and general condition of the patient by a physician is necessary.

Due to intra-patient variability, the observed hemoglobin level may sometimes be higher or lower than that desired in a given patient. The variability of hemoglobin should be managed by a dosage adjustment to maintain the target hemoglobin level between 10 g / dl (6.21 mmol / l) and 12 g / dl (7.45 mmol / l). Hemoglobin levels greater than 12 g / dl (7.45 mmol / l) should be avoided; recommendations for appropriate dosage adjustment when the observed hemoglobin level is greater than 12 g / dl (7.45 mmol / l) are described below.

The recommended starting dose is 20, 000 IU, independent of body weight, administered once a week. If, after 4 weeks of treatment, the hemoglobin level has increased by at least 1 g / dl (0.62 mmol / l), the current dose should be maintained. If the hemoglobin level has not increased by at least 1 g / dl (0.62 mmol / l), the dose should be doubled to 40, 000 IU weekly. If, after 4 additional weeks of treatment, the increase in hemoglobin remains insufficient, an increase of the dose to 60 000 IU per week should be considered.

The maximum dose should not exceed 60, 000 IU per week.

If, after 12 weeks of treatment, the hemoglobin level has not increased by at least 1 g / dl (0.62 mmol / l), a response is unlikely and treatment should be discontinued.

If the hemoglobin concentration increases by more than 2 g / dl (1.24 mmol / l) in 4 weeks or if the hemoglobin level exceeds 12 g / dl (7.45 mmol / l), the dose should be reduced from 25 to 50%. Treatment with epoetin theta should be temporarily suspended if the hemoglobin level exceeds 13 g / dl (8.07 mmol / l). Treatment should be reinstituted at a dose approximately 25% lower than the previous dose as soon as the hemoglobin level falls below 12 g / dl (7.45 mmol / l).

Treatment should be continued until 4 weeks after the end of chemotherapy.

Patients should be closely monitored to ensure that they receive the lowest approved dose of epoetin theta to appropriately control the symptoms of anemia.

Special populations

Pediatric patients

There is no experience in children and adolescents.

Administration mode

The solution can be administered subcutaneously or intravenously. The subcutaneous route is preferable in non-hemodialysis patients, to preserve the peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. In cancer patients with non-myeloid malignancies treated with chemotherapy, epoetin theta should be administered only subcutaneously.

Subcutaneous injection of epoetin theta may be performed in the abdomen, arm or thigh.

Eporatio is supplied in a single use pre-filled syringe. The solution must be visually inspected before use. Only a clear, colorless, particle free solution can be used. The injectable solution should not be shaken. Before injection, it is advisable to allow the solution to reach room temperature (15 ° C-25 ° C).

Eporatio should not be mixed with other medicines (see section Incompatibilities ).

To avoid any discomfort on injection sites, it is advisable to swap the sites with each injection and to inject the product slowly.

Against indications

- Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients.

- Uncontrolled hypertension.

Side effects Eporatio

The safety of epoetin theta was evaluated based on clinical study results including 972 patients.

About 8% of patients are likely to have effects. The most common side effects are hypertension, flu-like symptoms and headache.

The adverse reactions mentioned below are grouped by Organ System Class. Frequency groups are defined according to the following convention:

Very common: ≥ 1/10;

Frequency: ≥ 1/100 to <1/10;

Uncommon: ≥ 1/1000 to <1/100;

Rare: ≥ 1/10 000 to <1/1000;

Very rare: <1 / 10, 000;

Unknown: can not be estimated based on available data.

Class of organ system

Adverse reaction

Frequency

Symptomatic anemia associated with chronic renal failure

Symptomatic anemia associated with chemotherapy given in non-myeloid cancers.

Blood and lymphatic system disorders

Thromboembolic accidents

-

Unknown

Thrombosis of the vascular approach

Frequent

-

Immune system disorders

Hypersensitivity reactions

Unknown

Nervous system disorders

headaches

Frequent

Vascular disorders

Hypertension

Frequent

Hypertensive crisis

Frequent

-

Skin and subcutaneous tissue disorders

Skin reactions

Frequent

Musculoskeletal and systemic disorders

arthralgia

Frequent

General disorders and administration site conditions

Influenza-like pathology

Frequent

Thrombosis of the arteriovenous fistula can occur, especially in patients with hypotension or whose fistula presents with complications (stenosis or aneurysm) (see Warnings and Precautions for Use section ).

One of the most common adverse reactions during treatment with epoetin theta is an increase in blood pressure or worsening of pre-existing hypertension especially at the beginning of treatment. Hypertension is more common in patients with chronic renal failure during the correction phase than during the maintenance phase. It can be treated with appropriate antihypertensive drugs (see Warnings and Precautions section ).

Hypertensive shocks with encephalopathy-like symptoms (eg headache, confusional state, slurred speech, gait disorders) and related complications (seizures, stroke) may also occur in individual patients with high blood pressure usually low or normal (see Warnings and Precautions ).

Skin reactions such as rash, pruritus or injection site reactions may be observed.

Flu-like symptoms such as fever, chills and asthenia have been reported.

Some adverse reactions have not yet been observed with epoetin theta but are known with other epoetins

Isolated cases of erythroblastopenia due to the presence of neutralizing anti-erythropoietin antibodies have been reported in patients with chronic renal failure who received other epoetins. If PRCA is diagnosed, treatment with epoetin theta should be discontinued and patients should not receive another recombinant epoetin (see Warnings and Precautions ).

Popular Posts

Category Medicinal Products, Next Article