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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity ( 5.1 ) Interference with Blood Glucose Testing ( 5.2 ) Monitoring: Serum Anti-HBs Antibody Levels ( 5.3 ) Infusion Reactions ( 5.4 ) Transmissible Infectious Agents ( 5.5 ) Coagulation Disorders ( 5.6 ) Thrombotic Events ( 5.7 ) 5.1 Hypersensitivity Severe hypersensitivity reactions may occur with HepaGam B. HepaGam B should be administered in a setting with appropriate equipment, medication and personnel trained in the management of hypersensitivity, anaphylaxis and shock. In case of hypersensitivity, discontinue HepaGam B infusion immediately and begin appropriate emergency treatment. Medications such as epinephrine and antihistamines should be available for immediate treatment of acute hypersensitivity reactions. HepaGam B contains trace amounts of IgA (less than 40 micrograms per milliliter). Patients with known antibodies to IgA may have a greater risk of severe hypersensitivity and anaphylactic reactions. HepaGam B is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity reaction. (see CONTRAINDICATIONS [ 4 ]) 5.2 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 pyrroloquine quinone (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. 5.3 Monitoring: Serum Anti-HBs Antibody Levels Liver transplant patients should be monitored regularly for serum anti-HBs antibody levels using a quantitative assay to ensure that adequate protective levels are maintained. 5.4 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. 5.5 Transmissible Infectious Agents Because HepaGam B is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have been associated with the use of HepaGam B. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Saol Therapeutics at 1-877-443-0224. 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. 5.7 Thrombotic Events Thrombotic events may occur during or following treatment with IGIV products 4, 5 . Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients who are at risk of developing thrombotic events, administer HepaGam B at the minimum rate of infusion practicable.
6 ADVERSE REACTIONS The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects). The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Saol Therapeutics Inc. at 1-877-443-0224 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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 a clinical trial with 27 liver transplant patients, one adverse drug reaction was reported following the 578 (less than 1%) HepaGam B infusions. This study utilized the recommended dosing regimen outlined in Table 1 [ see Dosage and Administration ( 2.1 ) ]. The attributed adverse drug reaction of hypotension was reported in one patient. The reaction was associated with a single HepaGam B infusion during the first day post-transplant. The reaction resolved on the same day and did not recur with subsequent HepaGam B infusions. Healthy Volunteer Studies Seventy healthy male and female volunteers received a single dose of HepaGam B intramuscularly in clinical trials 6 . Only one adverse drug reaction, an episode of nausea, was reported. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of HepaGam B. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postexposure Prophylaxis: Dizziness has been reported in the postmarketing surveillance of HepaGam B for the postexposure prophylaxis indication. Hepatitis B-Related Liver Transplantation: The system organ classification of reported adverse reactions is provided below: Cardiac disorders: Sinus tachycardia Gastrointestinal disorders: Abdominal pain upper Nausea General disorders and administration site conditions: Chills Feeling cold Influenza like illness Pyrexia Immune system disorders: Anaphylactoid reaction Hypersensitivity Investigations: Lipase increased Transaminases increased Musculoskeletal and connective tissue disorders: Back pain Nervous system disorders: Dizziness Headache Respiratory, thoracic and mediastinal disorders: Dyspnoea Skin and subcutaneous tissue disorders: Cold sweat Healthcare professionals should report adverse reactions following the administration of HepaGam B to Saol Therapeutics at 1-833-644-4216 or FDA’s MedWatch reporting system at 1-800-FDA-1088 or www.fda.gov/medwatch .