Medicinal Products

EPORATIO 20,000 IU / 1 mL Injectable casing of 1 pre-filled syringe with 1 mL safety sys- tem

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: [EpoÚtine thÃ> ta, 4483]
laboratory: Ratiopharm

Injectable solution
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 20, 000 IU / 1 mL Injectable casing of 1 pre-filled syringe with 1 mL safety sys- tem

- 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.

Against indications

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

- Uncontrolled hypertension.

Side effects Eporatio

Summary of the security profile

About 9% of patients are likely to have effects. The most common side effects are hypertension, flu-like symptoms and headache.

Summary table of adverse effects

The safety of epoetin theta has been evaluated based on the results of clinical studies involving 972 patients.

The adverse reactions mentioned below in Table 1 are grouped by organ system class. Frequency groups are defined according to the following convention:

Very common: ≥ 1/10;

Frequency: ≥ 1/100, <1/10;

Uncommon: ≥ 1/1000, <1/100;

Rare: ≥ 1/10 000, <1/1000;

Very rare: <1 / 10, 000;

Not known: can not be estimated from the available data.

Table 1: adverse effects

Class of organ system

Undesirable effect

Frequency

Symptomatic anemia associated with chronic renal failure

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

affections

hematologic and lymphatic system

Pure red cell aplasia

(WSS) *

Frequency

unknown

-

Immune system disorders

reactions

hypersensitivity

Not known frequency

Nervous system disorders

headaches

Frequent

Vascular disorders

Hypertension*

Frequent

Hypertensive crisis *

Frequent

-

Thrombosis of the approach

vascular*

Frequent

accidents

thromboembolic

-

Frequency

unknown

Skin and subcutaneous tissue disorders

Skin reactions *

Frequent

Musculoskeletal and systemic disorders

arthralgia

-

Frequent

General disorders and administration site conditions

Influenza-like pathology *

Frequent

* See the sub-section "Description of some e:

'particular undesirable effects' below

Description of some specific adverse effects

Since the marketing of the product, cases of erythroblastoma penis (AEPA) due to the presence of neutralizing anti-erythropoietin antibodies have been reported with epoetin theta treatments in patients with chronic renal failure. If AEPA is diagnosed, treatment with epoetin theta should be discontinued and patients should not receive another recombinant epoetin (see Warnings and Precautions).

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 ).

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).

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.

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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