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adverse reactions
6 ADVERSE REACTIONS The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials (frequency ≥ 4% of patients) are inhibitor formation in previously untreated patients (PUPs) and minimally treated patients (MTPs), skin-related hypersensitivity reactions (e.g., rash, pruritus), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) line-associated infections in patients requiring a CVAD for intravenous administration. The most common adverse reactions observed in clinical trials (frequency ≥ 4% of patients) are inhibitor formation in previously untreated and minimally treated patients (PUPs and MTPs), skin-associated hypersensitivity reactions (e.g., rash, pruritus), urticaria, infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) line-associated infections. To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance Department at 1-866-915-6958 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 clinical trials of another drug and may not reflect the rates observed in clinical practice. Previously Treated Patients (PTPs) During the clinical studies conducted in PTPs, 451 adverse events (irrespective of the relationship to the study drug) were reported in the course of 24,936 infusions (1.8%). Twenty-four of the 451 adverse events were assessed as related to Helixate FS (0.1%). Adverse reactions reported by ≥ 4% of the patients are listed in Table 3 below. Table 3 Adverse Reactions (AR) in Previously Treated Patients (PTPs) with Frequency of ≥ 4% MedDRA Primary SOC Preferred Term Total No. of Patients: 73 No. of Patients with AR (%) Total No. of Infusions: 24,936 AR per Infusion (%) SOC = System Organ Class Skin and Subcutaneous Tissue Disorders Rash, pruritus 6 (8.2%) 0.02 General Disorders and Administration Site Conditions Infusion site reactions 3 (4.1%) 0.01 Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) In clinical studies with pediatric PUPs and MTPs, 726 adverse events were reported in the course of 9,389 infusions (7.7%). Twenty-nine of the 726 adverse events were assessed as related to Helixate FS (0.3%). Adverse reactions reported by ≥ 4% of the patients are listed in Table 4 below. Table 4 Adverse Reactions (AR) in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) with Frequency of ≥ 4% (Age Range 2-27 months) MedDRA Primary SOC Preferred Term Total No. of Patients: 61 No. of Patients with AR (%) Total No. of Infusions: 9,389 AR per Infusion (%) SOC = System Organ Class Skin and Subcutaneous Tissue Disorders Rash, pruritus, urticaria 10 (16.4) 0.01 Blood and Lymphatic System Disorders Factor VIII inhibition 9 (15) Denominator for de-novo inhibitors is N=60, since one patient had a pre-existing inhibitor. N/A General Disorders and Administration Site Conditions Infusion site reactions 4 (6.6) 0.04 Minimally Treated Patients (MTPs) in the Joint Outcome Study In the Joint Outcome Study in MTP pediatric patients treated with routine prophylaxis or episodic enhanced treatment for 5.5 years, 46 of the 65 randomized patients experienced adverse events over the study duration. Adverse events were not assessed for their relationship with Helixate FS. Table 5 Adverse Events (AE) in MTPs in the Joint Outcome Study (Age Range 0-6 years) MedDRA Primary SOC Preferred Term Total No. of Prophylaxis Arm Patients: 32 No. of Patients with AE (%) Total No. of Enhanced Episodic Arm Patients: 33 No. of Patients with AE (%) SOC = System Organ Class Surgical and Medical Procedures Central venous catheterization, Catheter removal 19 (59) 18 Three patients from the enhanced episodic arm had catheter removal. (55) Infections and Infestations Central line infection 6 (19) 6 (18) General Disorders and Administration Site Conditions Pyrexia 1 (3) 4 (12) Immunogenicity In clinical studies with 73 PTPs (defined as having more than 100 exposure days), one patient had a pre-existing inhibitor. In the other 72 patients, followed over 4 years, no de-novo inhibitors were observed. In clinical studies with pediatric PUPs and MTPs, inhibitor development was observed in 9 out of 60 patients (15%), 6 were high titer 1 (>5 BU) and 3 were low-titer inhibitors. Inhibitors were detected at a median number of 7 exposure days (range 2 to 16 exposure days). In the Joint Outcome Study with Helixate FS, 5 de-novo inhibitor development was observed in 8 of 64 patients with negative baseline values (12.5%), 2 patients developed high titer 1 (>5 BU) and were withdrawn from the study. Six patients developed low-titer inhibitors. Inhibitors were detected at a median number of 44 exposure days (range 5 to 151 exposure days). 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of Helixate FS. 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. Among patients treated with Helixate FS, cases of serious allergic/hypersensitivity reactions (which may include facial swelling, flushing, hives, blood pressure decrease, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, vomiting) have been reported, particularly in very young patients or patients who have previously reacted to other factor VIII concentrates. The following table represents the post-marketing adverse reactions as MedDRA Preferred Terms. Table 6 Post-Marketing Experience MedDRA Primary SOC Preferred Term SOC = System Organ Class Blood and Lymphatic System Disorders FVIII inhibition Skin and Subcutaneous Tissue Disorders Pruritus, urticaria, rash General Disorders and Administration Site Conditions Infusion site reaction Pyrexia Immune System Disorders Anaphylactic reaction, other hypersensitivity reactions
adverse reactions table
<table width="432.000" ID="table4"> <caption ID="id_c92bdee5-c720-4e43-9e2d-3ef9846ca430">Table 4 Adverse Reactions (AR) in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) with Frequency of ≥ 4% (Age Range 2-27 months)</caption> <col width="25.0%" align="left"/> <col width="25.0%" align="left"/> <col width="25.0%" align="center"/> <col width="25.0%" align="center"/> <thead> <tr ID="id_989a662f-c6f3-4799-b0da-d621bb02c344" styleCode="Botrule"> <td align="left" valign="top" styleCode="Lrule Rrule">MedDRA Primary SOC </td> <td align="left" valign="top" styleCode="Rrule">Preferred Term </td> <td align="left" valign="top" styleCode="Rrule">Total No. of Patients: 61 No. of Patients with AR (%) </td> <td align="left" valign="top" styleCode="Rrule">Total No. of Infusions: 9,389 AR per Infusion (%) </td> </tr> </thead> <tfoot ID="id_bf830ae5-124a-4603-a64f-463c26a22c4c"> <tr> <td align="left" valign="top" colspan="4" styleCode="Lrule Rrule"> <content styleCode="bold">SOC = System Organ Class </content> </td> </tr> </tfoot> <tbody> <tr ID="id_56044377-14e8-401a-8c3d-69aed2c8dc35" styleCode="Toprule"> <td align="left" valign="top" styleCode="Lrule Rrule">Skin and Subcutaneous Tissue Disorders </td> <td align="left" valign="top" styleCode="Rrule">Rash, pruritus, urticaria </td> <td align="left" valign="top" styleCode="Rrule">10 (16.4)</td> <td align="left" valign="top" styleCode="Rrule">0.01</td> </tr> <tr ID="id_ff76311d-c0d5-4df9-9676-7ef776ca6f64"> <td align="left" valign="top" styleCode="Lrule Rrule">Blood and Lymphatic System Disorders </td> <td align="left" valign="top" styleCode="Rrule">Factor VIII inhibition </td> <td align="left" valign="top" styleCode="Rrule">9 (15)<footnote ID="idav0vde">Denominator for <content styleCode="italics">de-novo </content>inhibitors is N=60, since one patient had a pre-existing inhibitor.</footnote> </td> <td align="left" valign="top" styleCode="Rrule">N/A</td> </tr> <tr ID="id_10cc1379-e7a1-4497-8b3f-e7118d9ac65f"> <td align="left" valign="top" styleCode="Lrule Rrule">General Disorders and Administration Site Conditions </td> <td align="left" valign="top" styleCode="Rrule">Infusion site reactions </td> <td align="left" valign="top" styleCode="Rrule">4 (6.6)</td> <td align="left" valign="top" styleCode="Rrule">0.04</td> </tr> </tbody> </table>