Hemactiv Special Precautions

Iron supplements: Before starting treatment with Hemactiv, other causes of anemia (iron deficiency, hemolysis, blood loss, deficiency of vitamin B12 or folate) should take into account and treated. In most cases, serum ferritin drops simultaneously with the increase in hematocrit. In order to ensure optimum response to Hemactiv, suitable iron deposits should be ensured, so supplements should be administered if necessary, usually 200-300 mg/day daily: In patients with chronic renal failure whose serum ferritin levels are below 100 ng/mL a supplement of oral iron of e.g. 200-300 mg/day is recommended (100-200 mg/day for pediatric patients).
In patients with cancer whose transferrin saturation is below 20% a supplement of oral iron of 200-300 mg/day is recommended.
In patients on a pre-donation program, oral elemental iron 200 mg/day should be administered several weeks before. In patients undergoing elective surgery, oral iron 200 mg/day should be administered prior to Hemactiv, if possible, and if not during treatment.
If the patient does not respond or maintain the response, the following etiologies should be evaluated and considered: Iron deficiency; Underlying malignant, infectious or inflammatory processes; Occult blood loss; Underlying hematological diseases (thalassemia, refractory anemia or other myelodysplastic disorders); Vitamin deficiencies (vitamin B12, folic acid); Hemodialysis; Aluminum poisoning; Fibrous cystic osteitis.
Hemactiv contains albumin derived from human blood. Based on the effective donor screening and product manufacturing process, this would lead to a rare remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt Jacob disease (CJD) is considered remote. No cases of transmission of viral diseases or CJD identified associated with albumin has been reported.
Serious allergic reactions: With the use of an erythropoietin alpha such as Hemactiv, a serious allergic reaction, including anaphylactic reaction, angioedema, bronchospasm, rash, and urticaria may develop. If a serious allergic or anaphylactic reaction occurs, discontinue immediately the Hemactiv therapy and consult the doctor.
The various erythropoiesis stimulating factors are not necessarily equivalent, so it is important to consult the health care professional before making any changes.
Platelet counts during the first 8 weeks of treatment with Hemactiv are suggested as a dose-dependent increasing in platelets may occurs which becomes normal during therapy. Thrombocytopenia has been also reported.
Use with caution in patients with gout, as increased uric acid could be observed.
Use with caution in patients with chronic liver disease, as these patients may have increased erythropoiesis.
Genotoxicity: EPO alpha did not induce gene mutations nor caused chromosomal damage.
Carcinogenicity: There are conflicting reports in literature regarding the potential role in tumor proliferation of erythropoietin stimulating agents, however, long-term studies have not been conducted.
Effects on the ability to operate machines: No studies have been conducted regarding erythropoietin and the ability of driving vehicles and operate machines.
Use in Pregnancy: Category B3 (Australia): It is not known if EPO alpha crosses the placenta or if it can produce fetal harm when administered to a pregnant woman. There are no adequate and well controlled studies in pregnant women. Studies in rats showed that doses of 20-500 IU/kg/day produced decreased fertility, increased losses, decreased fetal weight, and delayed ossification. Recombinant human erythropoietin can be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: It is not known if recombinant human erythropoietin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered recombinant human erythropoietin to breastfeeding mothers. Exposed animals showed retarded growth and development of offspring.
Use in Children: There are clinical trials supporting the effect of erythropoietin alpha in children as to correction of anemia, reduced transfusion requirements, improved bleeding tendency in uremia, increased appetite, decreased cytotoxic antibodies.
Safety reported for pediatric patients is incomplete, particularly with regard to hemoglobin range management and changes in blood pressure.