Eporatio Adverse Reactions

Summary of the safety profile: Approximately 9% of patients can be expected to experience an adverse reaction. The most frequent adverse reactions are hypertension, influenza-like illness and headache.
Tabulated list of adverse reactions: The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.
Adverse reactions listed in the table as follows are classified according to System Organ Class. Frequency groupings are defined according to the following convention: Very common: ≥ 1/10; Common: ≥ 1/100 to < 1/10; Uncommon: ≥ 1/1,000 to < 1/100; Rare: ≥ 1/10,000 to < 1/1,000; Very rare: < 1/10,000; Not known: cannot be estimated from the available data. (See table.)

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Description of selected adverse reactions: In patients with chronic renal failure, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with epoetin theta therapy has been reported in post marketing setting. If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see Precautions).
One of the most frequent adverse reactions during treatment with epoetin theta is an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase. Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase. Hypertension can be treated with appropriate medicinal products (see Precautions).
Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual patients with otherwise normal or low blood pressure (see Precautions).
Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see Precautions).
Skin reactions such as rash, pruritus or injection site reactions may occur.
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see Precautions).
Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.