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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] • Hypotension [ see Warnings and Precautions ( 5.2 ) ] • Iron Overload [ see Warnings and Precautions ( 5.3 ) ] • Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 ) • Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 may not reflect the rates observed in practice. Adverse Reactions in Adult Patients with CKD The frequency of adverse reactions associated with the use of Iron Sucrose Injection has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD. Adverse reactions reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Iron Sucrose Injection exceeds the rate for comparator are listed by indication in Table 1. Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered. Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks. Table 1. Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Iron Sucrose Injection Exceeds the Rate for Comparator * EPO=Erythropoietin Body System/Adverse Reactions HDD-CKD NDD-CKD PDD-CKD Iron Sucrose Injection Iron Sucores Injection Oral Iron Iron Sucorse Injection EPO* Only (N=231) (N=139) (N=139) (N=75) (N=46) % % % % % Subjects with any adverse reaction 78.8 76.3 73.4 72.0 65.2 Ear and Labyrinth Disorders Ear Pain 0 2.2 0.7 0 0 Eye Disorders Conjunctivitis 0.4 0 0 2.7 0 Gastrointestinal Disorders Abdominal pain 3.5 1.4 2.9 4.0 6.5 Diarrhea 5.2 7.2 10.1 8.0 4.3 Dysgeusia 0.9 7.9 0 0 0 Nausea 14.7 8.6 12.2 5.3 4.3 Vomiting 9.1 5.0 8.6 8.0 2.2 General Disorders and Administration Site Conditions Asthenia 2.2 0.7 2.2 2.7 0 Chest pain 6.1 1.4 0 2.7 0 Feeling abnormal 3.0 0 0 0 0 Infusion site pain or burning 0 5.8 0 0 0 Injection site extravasation 0 2.2 0 0 0 Peripheral edema 2.6 7.2 5.0 5.3 10.9 Pyrexia 3.0 0.7 0.7 1.3 0 Infections and Infestations Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis 2.6 2.2 4.3 16.0 4.3 Injury, Poisoning and Procedural Complications Graft complication 9.5 1.4 0 0 0 Metabolism and Nutrition Disorders Fluid overload 3.0 1.4 0.7 1.3 0 Gout 0 2.9 1.4 0 0 Hyperglycemia 0 2.9 0 0 2.2 Hypoglycemia 0.4 0.7 0.7 4.0 0 Musculoskeletal and Connective Tissue Disorders Arthralgia 3.5 1.4 2.2 4.0 4.3 Back pain 2.2 2.2 3.6 1.3 4.3 Muscle cramp 29.4 0.7 0.7 2.7 0 Myalgia 0 3.6 0 1.3 0 Pain in extremity 5.6 4.3 0 2.7 6.5 Nervous System Disorders Dizziness 6.5 6.5 1.4 1.3 4.3 Headache 12.6 2.9 0.7 4.0 0 Respiratory, Thoracic and Mediastinal Disorders Cough 3.0 2.2 0.7 1.3 0 Dyspnea 3.5 5.8 1.4 1.3 2.2 Nasal congestion 0 1.4 2.2 1.3 0 Skin and Subcutaneous Tissue Disorders Pruritus 3.9 2.2 4.3 2.7 0 Vascular Disorders Hypertension 6.5 6.5 4.3 8.0 6.5 Hypotension 39.4 2.2 0.7 2.7 2.2 One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had prior other intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Iron Sucrose Injection there were no occurrences of adverse reactions that precluded further use of Iron Sucrose Injection [see Warning and Precautions ( 5 )] . Adverse Reactions in Pediatric Patients with CKD (ages 2 years and older) In a randomized, open-label, dose-ranging trial for iron maintenance treatment with Iron Sucrose Injection in pediatric patients with CKD on stable erythropoietin therapy [see Clinical Studies ( 14.7 )] , at least one adverse reaction was experienced by 57% (27/47) of the patients receiving Iron Sucrose Injection 0.5 mg/kg, 53% (25/47) of the patients receiving Iron Sucrose Injection 1 mg/kg, and 55% (26/47) of the patients receiving Iron Sucrose Injection 2 mg/kg. A total of 5 (11%) subjects in the Iron Sucrose Injection 0.5 mg/kg group, 10 (21%) patients in the Iron Sucrose Injection 1 mg/kg group, and 10 (21%) patients in the Iron Sucrose Injection 2 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%). 6.2 Adverse Reactions from Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Iron Sucrose Injection. 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. In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by > 1% were cardiac failure congestive, sepsis and dysgeusia. • Immune system disorders: anaphylactic - type reactions, angioedema • Psychiatric disorders: confusion • Nervous system disorders: convulsions, collapse, light-headedness, loss-of-consciousness • Cardiovascular System: bradycardia, shock, acute myocardial ischemic with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction. • Respiratory, thoracic and mediastinal disorders: bronchospasm, dyspnea • Musculoskeletal and connective tissue disorders: back pain, swelling of the joints • Renal and urinary disorders: chromaturia • General disorders and administration site conditions: hyperhidrosis Symptoms associated with Iron Sucrose Injection total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Iron Sucrose Injection. Reactions have occurred following the first dose or subsequent doses of Iron Sucrose Injection. Symptoms may respond to intravenous fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms. Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.