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adverse reactions
ADVERSE REACTIONS Increases of creatinine and blood urea nitrogen (BUN) have been observed as soon as 1 to 2 days following infusion of IGIV. Progression to oliguria and anuria requiring dialysis has been observed, although some patients have improved spontaneously following cessation of treatment (19). Types of severe renal adverse reactions that have been seen following IGIV therapy include: acute renal failure, acute tubular necrosis (20), proximal tubular nephropathy, and osmotic nephrosis (6). Certain severe adverse reactions may be related to the rate of infusion. The recommended infusion rate [See DOSAGE AND ADMINISTRATION ] must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Adverse reactions may occur more frequently when a high infusion rate is used, the treatment is the initial exposure to immunoglobulin, the immunoglobulin product has been changed to that of a different manufacturer, or there has been a long interval (more than 8 weeks) since the previous infusion. Slowing or stopping an infusion usually results in the prompt disappearance of symptoms. Postmarketing: The following adverse reactions have been identified and reported during the post-approval use of IGIV products (21). Respiratory Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm Cardiovascular Cardiac arrest, thromboembolism, vascular collapse, hypotension Neurological Coma, loss of consciousness, seizures, tremor Integumentary Stevens-Johnson Syndrome, epidermolysis, erythema multiformae, bullous dermatitis Hematologic Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test General/Body as a Whole Pyrexia, rigors Musculoskeletal Back pain Gastrointestinal Hepatic dysfunction, abdominal pain Because postmarketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently. Adverse events were reported in a study of 51 individuals with primary humoral immunodeficiency diseases receiving infusions every 3 to 4 weeks of 300 to 600 mg/kg body weight. Forty-nine (96%) subjects experienced at least 1 adverse event irrespective of the relationship with the product, and these subjects reported a total of 784 adverse events. None of the 51 subjects who participated in this study discontinued the study prematurely due to an adverse experience. Adverse events that occurred with an incidence of > 15% on a per subject basis are summarized in Table 6 . No adverse events occurred with an incidence of > 2% on a per infusion basis. Table 6. Adverse Events Occurring with an Incidence of > 15% Adverse Event Number of AEs Number of Subjects with AE Percent of Subjects with AE a NOS = not otherwise specified. Bronchitis 17 10 20 Cough and productive cough 26 13 25 Diarrhoea NOS a 16 10 20 Headache NOS and sinus headache 61 27 53 Nasal congestion 22 11 21 Pain NOS 14 8 16 Pyrexia 31 14 27 Rhinorrhoea 16 10 20 Sinusitis NOS 43 20 39 Sore throat NOS 13 10 20 Upper Respiratory tract infection 22 17 33 Wheezing and asthma aggravated 24 9 18 Forty-six (90%) subjects had 331 adverse events that occurred during an infusion or within 72 hours after the completion of the infusion. Therefore 42% of all adverse events, regardless of assessed causality, were temporally associated with the infusion of Flebogamma ® 5%. Overall, 217 of 746 infusions (29%) were temporally associated with 1 or more adverse events occurring within 72 hours after an infusion, regardless of assessed relationship to treatment; the 1-sided, 95%, upper-bound confidence interval was 34%. A summary of infusions with mild, moderate, and severe treatment-related adverse events is in Table 7 . Table 7. Summary of Infusions with Mild, Moderate, and Severe Treatment-Related Adverse Events Severity of AE No. Infusions with AE Adjusted % a Confidence Interval b a Adjusted % = average of the % of infusions with a treatment-related adverse event for each individual subject. b The 95% upper bound for the adjusted % of infusions for which at least 1 treatment-related adverse event was reported was derived by using the t-statistic. Mild 49 6.2 8.4 Moderate 12 1.5 2.3 Severe 3 0.4 0.8 The number and percent of subjects with treatment-emergent rises in AST or ALT are in Table 8 . Table 8. Number (%) of Subjects with Treatment-Emergent Rises in AST or ALT (N = 51) Laboratory Test n % Assessment Criteria a ULN = upper limit of normal. AST Above the ULN a 22 43 Above 3 x the ULN 3 6 ALT Above the ULN 16 31 Above 3 x the ULN 1 2 None of these subjects had a concomitant treatment-emergent rise in total bilirubin. Reported adverse reactions with Flebogamma ® 5% and other IGIV products include: headache, chills, fever, shaking, fatigue, malaise, anxiety, back pain, muscle cramps, abdominal cramps, blood pressure changes, chest tightness, palpitations, tachycardia, nausea, vomiting, cutaneous reactions, wheezing, rash, arthralgia, and edema, often beginning within 60 minutes of the start of the infusion. Rarely, Immune Globulin Intravenous (Human) can induce a severe fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with IGIV. In the case of shock, the current medical standards for shock treatment should be implemented.
adverse reactions table
<table width="100%"> <col width="50.000%" align="left"/> <col width="50.000%" align="left"/> <tbody> <tr> <td align="left" valign="top"> <content styleCode="bold">Respiratory</content> </td> <td align="left" valign="top">Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">Cardiovascular</content> </td> <td align="left" valign="top">Cardiac arrest, thromboembolism, vascular collapse, hypotension </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">Neurological</content> </td> <td align="left" valign="top">Coma, loss of consciousness, seizures, tremor </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">Integumentary</content> </td> <td align="left" valign="top">Stevens-Johnson Syndrome, epidermolysis, erythema multiformae, bullous dermatitis </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">Hematologic</content> </td> <td align="left" valign="top">Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">General/Body as a Whole</content> </td> <td align="left" valign="top">Pyrexia, rigors </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">Musculoskeletal</content> </td> <td align="left" valign="top">Back pain </td> </tr> <tr> <td align="left" valign="top"> <content styleCode="bold">Gastrointestinal</content> </td> <td align="left" valign="top">Hepatic dysfunction, abdominal pain </td> </tr> </tbody> </table>