Hemax Adverse Reactions

Chronic renal failure patients: Arterial hypertension: More than 80% of hemodialysis patients have a history of arterial hypertension. Arterial tension should be strictly controlled when epoetin alpha treatment is initiated and antihypertensive treatments as well as food intake restrictions should be corrected accordingly. It has been reported that approximately 25% of patients on dialysis treated with epoetin alpha may develop hypertension and consequently, adjustments in antihypertensive therapy should be made.
There is an eventual relationship between the velocity of hematocrit rise and the exacerbation of arterial tension. Therefore, a decrease of Hemax dose is recommended if hematocrit increases more than 4 points during a 2-week period.
Pure red cell aplasia: Since epoetin alpha is a protein, some patients may develop antibodies to Hemax. Some cases of pure red cell aplasia have been associated with neutralizing antibodies with epoetin alpha containing products. This has been reported in patients with renal failure who received the drug by subcutaneous route. These patients shall not receive Hemax or any other epoetin containing product.
Thrombotic events: An increase of thrombotic events has occurred in dialysis patients with cardiovascular disease receiving epoetin alpha. These included vascular access thrombosis, myocardial acute infarction and others. Thrombotic events were observed in patients assigned to reach a target hematocrit >40%. Moreover, this group showed higher mortality rates. During dialysis, patients may require increased heparin doses to prevent venous access thrombosis. Haemoglobin levels above 12 g/dL may be associated to a higher risk of cardiovascular events.
Seizures: In clinical trials with epoetin alpha, approximately 5% of adult patients on dialysis had seizures generally associated with arterial hypertension crisis. Arterial tension should be closely monitored before and during treatment. Caution should be taken when administering epoetin alpha to patients with history of seizures.
Zidovudine-treated HIV-infected patients: Differently from renal failure patients, no exacerbation of arterial hypertension, seizures or thrombotic events have been reported for this group of patients.
Cancer patients on chemotherapy: A higher incidence of thrombotic events and increase of mortality has been observed in patients with breast cancer on chemotherapy, assigned to epoetin alpha treatment to maintain high haemoglobin levels (12 to 14 g/dl).
Albumin (human): Hemax contains albumin, a derivative of human blood. The risk for transmission of viral diseases is considered extremely remote based on the albumin obtention and manufacturing process of the product. The theoretical risk for the transmission of the Creutzfeldt-Jakob disease is also considered extremely remote.
No cases of transmission of viral disease have been identified for albumin.
The table as follows details the adverse reactions requiring medical care: See Table 4.

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The table as follows details the adverse reactions requiring medical care only to the extent they are sustained over time or hinder daily activity: See Table 5.

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Paediatric Use: Although multiple studies have been performed in newborn babies, nursing infants and older children and have demonstrated that HEMAX is safe for the prevention and treatment of anaemia, the long-term safety of this product has not been established yet.