Hema-Plus Warnings

General: The essential purpose of Hema-Plus is not the solution of cases of severe anemia that call for immediate correction. This product may obviate the need for treatment with transfusion, but is not a substitute for emergency transfusions, whatever the case is. It is neither indicated to rectify anemia in these specifics groups of patients when the anemic condition are caused from factors other than chronic renal failure or chemotherapy in cancer patients.
Chronic renal disease patients: Hypertension: It is very important to control arterial hypertension in patients with renal disease. It is deemed advisable that the dose of Hema-Plus be decreased if the hematocrit level exceeds 4 points in any two-week period (see Adverse Reactions).
Seizure: Have been reported in one patient with chronic renal failure treated with Epoetin alfa. It is deemed advisable that the dose of Hema-Plus be decreased if the hematocrit level exceeds 4 points in any two-week period (see Adverse Reactions).
Thrombotic events: During hemodialysis, patients treated with Hema-Plus may require increased anticoagulation to prevent clotting of the artificial kidney (see Adverse Reactions).
Cancer patients: Other stimulating agents of the erythropoiesis report an increased incidence of thromboembolic reactions, some serious and mortal, in this group of patient. It has also been described, an increase of the mortality and increase of the risk of tumoral progression or recurrence in patients with cancer.
Hema-Plus is indicated in patient with symptomatic anemia associated to the chemotherapy and when the hemoglobin levels are inferior to 10 g/dL; its preventive use is not recommended in patient with normal hemoglobin levels at the beginning of the treatment with chemotherapy and/or radiotherapy.
In these patients, before beginning the treatment with Hema-Plus other causes should be discarded, as for example the iron deficit, bleeding and hemolysis.
There is no evidence that support the role of the hematopoietic agent on the improvement of survival and response to treatment.
However, an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients treated with erythropoiesis-stimulating agents, risk-benefit should be carefully weighed in treatment with epoetin alfa in cancer patients and patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e.g. deep vein thrombosis or pulmonary embolism).