HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non A, non B hepatitis. As indicated under Clinical Pharmacology, however, a group of such patients treated with HEMOFIL M AHF did not demonstrate signs or symptoms of non A, non B hepatitis over observation periods ranging from three to nine months.
Certain components used in the packaging of this product contain natural rubber latex.
Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is initiated.
No benefit may be expected from this product in treating other deficiencies.
The processing of HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, significantly reduces the presence of blood group specific antibodies in the final product.
Formation of Antibodies to Mouse Protein
Although no hypersensitivity reactions have been observed, because HEMOFIL M AHF contains trace amounts of mouse protein (less than 0.1 ng/AHF activity units), the possibility exists that patients treated with this product may develop hypersensitivity to the mouse proteins.
The pulse rate should be determined before and during administration of HEMOFIL M AHF. Should a significant increase occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
Information for Patients
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women, or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and should be advised to discontinue use of the product and contact their physician if these symptoms occur.
Although dosage can be estimated by the calculations which follow, it is strongly recommended that whenever possible, appropriate laboratory tests be performed on the patient's plasma at suitable intervals to assure that adequate AHF levels have been reached and are maintained.
If the AHF content of the patient's plasma fails to reach expected levels or if bleeding is not controlled after apparently adequate dosage, the presence of inhibitor should be suspected. By appropriate laboratory procedures, the presence of inhibitor can be demonstrated and quantified in terms of AHF units neutralized by each mL of plasma or by the total estimated plasma volume.
If the inhibitor is at low levels (i.e., <10 Bethesda Units/mL), after administration of sufficient AHF units to neutralize the inhibitor, additional AHF units will elicit the predicted response.
Pregnancy Category C. Animal reproduction studies have not been conducted with HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified. It is not known whether HEMOFIL M AHF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMOFIL M AHF should be given to a pregnant woman only if clearly needed.