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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of transmission of infectious agents from human plasma ( 5.1 ) Anaphylactic Precautions ( 5.2 ) Interference with non-glucose-specific blood glucose monitoring systems may result in elevated glucose readings that can lead to untreated hypoglycemia or inappropriate insulin administration ( 5.3 ) Infusion rate precautions ( 5.5 ) IM injections may be contraindicated in patients with coagulation disorders ( 5.6 ) 5.1 General HepaGam B is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob disease agent. The risk that such products can 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. The HepaGam B manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. HepaGam B is filtered using a Planova 20N Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician to have been transmitted by this product should be reported by the physician or other healthcare provider to Cangene Corporation at 1-800-768-2304. The physician should discuss the risks and benefits of this product with the patient. 5.2 Anaphylactic Precautions Although allergic reactions have not been reported following HepaGam B administration [ see Adverse Reactions (6.2) ], the product should be administered only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available. If hypotension or anaphylaxis occurs, the administration of HepaGam B should be discontinued immediately and supportive care given as needed. 5.3 Interference with Blood Glucose Testing The maltose contained in HepaGam B can interfere with some types of blood glucose monitoring systems, i.e., those based on the glucose dehydrogenase pyrroloquinequinone (GDH-PQQ) method. This can result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated results. 5.4 Monitoring: Serum anti-HBs Antibody Levels Liver transplant patients should be monitored regularly for serum anti-HBs antibody levels using a quantitative assay [ see Dosage and Administration (2.1) ]. 5.5 Infusion Reactions Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under Dosage and Administration (2.1) must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period and immediately following an infusion. 5.6 Coagulation Disorders For postexposure prophylaxis indications, HepaGam B must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B should be given only if the expected benefits outweigh the potential risks.
6 ADVERSE REACTIONS The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cangene Corporation at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Overall Adverse Reaction Profile The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain 7,8 . In a clinical trial in liver transplant patients, 2 adverse drug reactions of tremor and hypotension were reported in 2 of 14 patients who received intravenous infusions of HepaGam B 8 . In studies with healthy volunteers, only 1 adverse drug reaction of nausea was reported in the 70 adult subjects who received an intramuscular administration of HepaGam B 8 . Although no anaphylactic reactions have been reported following HepaGam B administration, anaphylactic reactions have been reported following the administration of other immune globulin products on rare occasions [ see Warnings and Precautions (5.2) ]. 6.2 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hepatitis B-Related Liver Transplantation In an ongoing clinical trial, only 2 adverse drug reactions occurred following the 313 (<1%) HepaGam B infusions in 14 liver transplant patients. A listing of all adverse events (including those assessed as unrelated to study drug) occurring in >10% of patients are summarized in Table 4 below. These adverse events were reported in an interim analysis from a one-year Phase 3 clinical trial examining HepaGam B for the prevention of hepatitis B recurrence following liver transplantation. This study utilized the recommended dosing regimen outlined in Table 1 [ see Dosage and Administration (2.1) ]. The 2 attributed adverse drug reactions of tremor and hypotension were reported in 2 patients. All reactions were associated with a single HepaGam B infusion during the first week post-transplant. All reactions resolved on the same day and did not recur with subsequent HepaGam B infusions. Table 4 - Adverse Events (AEs) Occurring in >10% of Liver Transplant Patients Adverse Event by system organ class Number of AEs (in number of patients) N=14 Blood and lymphatic systems disorder - Splenomegaly 8 (6) Eye disorders - Presbyopia 2 (2) Gastrointestinal disorders - Aphthous stomatitis - Diarrhoea - Dyspepsia - Gingival Hyperplasia 3 (3) 10 (8) 5 (5) 3 (3) General disorders - Fatigue - Oedema peripheral - Pyrexia 6 (6) 3 (2) 3 (3) Hepatobiliary disorders - Hepatobiliary disease 3 (3) Immune system disorders - Liver transplant rejection 7 (5) Infections and infestations - Diarrhoea Infectious - Pneumonia - Sepsis 2 (2) 2 (2) 3 (2) Metabolism and nutrition disorders - Hyperglycaemia 4 (4) Musculoskeletal - Back pain 2 (2) Nervous system disorders - Amnesia - Essential Tremor - Headache 2 (2) 6 (2) 15 (9) Psychiatric disorders - Agitation 2 (2) Renal and urinary disorders - Nocturia 2 (2) Respiratory, thoracic and mediastinal - Pleural effusion 3 (3) Skin and subcutaneous tissue disorders - Pruritus - Rash 3 (3) 2 (2) Vascular disorders - Hypertension - Hypotension 8 (7) 2 (2) Healthy Volunteer Studies Seventy healthy male and female volunteers received a single dose of HepaGam B intramuscularly in clinical trials 8 . Seventeen (17) subjects reported 30 adverse events following administration of HepaGam B. The most frequently reported adverse events included 4 subjects (6%) who experienced headache, 7 subjects (10%) who had cold symptoms or flu and 2 subjects (3%) who experienced lightheadedness/fainted. The majority of events were reported as mild and were not related to study drug. One adverse event, an episode of nausea, was considered to be drug related. There were no serious adverse events reported. A similar number of subjects in the comparator groups reported adverse events. 6.3 Postmarketing Experience As of April 2007, there have been no postmarketing adverse events reported for HepaGam B administered IM