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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity or allergic reactions have been observed, and may in some cases progress to severe anaphylaxis. Epinephrine should be available immediately to treat any acute hypersensitivity reaction. (5.1) Hypervolemia: Use with caution in patients who are at risk of hypervolemia or hemodilution. Stop infusion if signs of cardiovascular overload occur. (5.2) Electrolyte imbalances have been observed. Monitor electrolyte status. (5.3) Ensure adequate substitution of other blood constituents. Monitor coagulation status and hematocrit. (5.4) Hypotension has been observed. Monitor hemodynamic performance. (5.5) Do not dilute solution with sterile water for injection. (5.6) This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. (5.7) 5.1 Hypersensitivity Hypersensitivity or allergic reactions have been observed, and may in some cases progress to severe anaphylaxis. Epinephrine should be available immediately to treat any acute hypersensitivity reaction. 5.2 Hypervolemia/Hemodilution Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of possible cardiovascular overload, e.g., headache, dyspnea, increased blood pressure, jugular venous distention, elevated central venous pressure, pulmonary edema, the infusion should be stopped immediately and the patient reevaluated. Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient. Examples of such conditions are: Decompensated cardiac insufficiency Hypertension Esophageal varices Pulmonary edema Hemorrhagic diathesis Severe anemia Renal and post-renal anuria. 5.3 Electrolyte Imbalance 20-25% Albumin (Human) is relatively low in electrolytes compared to the 4-5% Albumin (Human) solutions. When albumin is given, monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance. 5.4 Coagulation Abnormalities If comparatively large volumes are to be replaced, monitoring of coagulation and hematocrit is necessary. Ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes). 5.5 Laboratory Monitoring If ALBUMIN (HUMAN) 20% is to be administered, monitor hemodynamic performance regularly; this may include: Arterial blood pressure and pulse rate Central venous pressure Pulmonary artery occlusion pressure Urine output Electrolytes Hematocrit/hemoglobin. 5.6 Application Precautions ALBUMIN (HUMAN) 20% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. 5.7 Infection Risk from Human Plasma This product is a derivative of human plasma. Based on effective donor screening and product manufacturing processes it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have been identified for ALBUMIN (HUMAN) 20%.
6 ADVERSE REACTIONS Most common adverse reactions seen in clinical trials (greater than or equal to 5% incidence) were anaphylactoid type reactions. To report SUSPECTED ADVERSE REACTIONS, contact Octapharma USA Inc. at phone # 866-766-4860 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 General The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema. The most common adverse events are anaphylactoid type of reactions. Adverse reactions for ALBUMIN (HUMAN) 20% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated. 6.2 Clinical Studies Experience No clinical studies were done using ALBUMIN (HUMAN) 20% 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ALBUMIN (HUMAN) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency. Table 1 Adverse reactions observed for ALBUMIN HUMAN (any strength) during post-marketing phase (in decreasing order of severity) Observed Adverse Reactions anaphylactic shock cardiac failure loss of consciousness circulatory failure hypersensitivity congestive heart failure pulmonary edema dyspnea hypotension hypertension tachycardia bradycardia vomiting urticaria angioneurotic edema rash erythematous confusional state headache chills pyrexia flushing nausea pruritus hyperhidrosis No drug interaction studies have been conducted.