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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after hemodialysis and until clinically stable. ( 5.1 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions [ see Adverse Reactions (6) ]. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving Triferic in two randomized clinical trials. 5.2 Iron Laboratory Testing Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity reactions [ see Warnings and Precautions (5.1) ]. The most common adverse reactions in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea. To report SUSPECTED ADVERSE REACTIONS, contact Rockwell Medical at 1-855-333-4315 or 1-248-960-9009 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 may not reflect the rates observed in practice. In two randomized, placebo-controlled clinical trials, a total of 292 patients were administered Triferic for periods of up to 1 year [ see Clinical Studies (14) ]. The mean total exposure in the randomized treatment period was 5 months. A total of 296 patients received placebo treatment for a similar time period. In the two studies, 64% were male and 54% were Caucasian. The median age of patients was 60 years (range, 20 to 89 years). Adverse events occurring in 3% or greater of patients treated with Triferic in the randomized clinical trials are listed in Table 1. Table 1: Adverse Reactions Reported in Two Clinical Trials in at Least 3% of Patients Receiving Triferic and at an Incidence at Least 1% Greater than Placebo System Organ Class Preferred Term Triferic N=292 n (%) Placebo N=296 n (%) Number of patients with at least one adverse reaction 229 (78.4) 223 (75.3) General Disorders and Administration Site Conditions Peripheral edema 20 (6.8) 11 (3.7) Pyrexia 13 (4.5) 9 (3.0) Asthenia 12 (4.1) 9 (3.0) Fatigue 11 (3.8) 6 (2.0) Infections and Infestations Urinary tract infection 13 (4.5) 4 (1.4) Injury, Poisoning, and Procedural Complications Procedural hypotension 63 (21.6) 57 (19.3) Arteriovenous fistula thrombosis 10 (3.4) 6 (2.0) Arteriovenous fistula site hemorrhage 10 (3.4) 5 (1.7) Musculoskeletal and Connective Tissue Disorders Muscle spasms 28 (9.6) 24 (8.1) Pain in extremity 20 (6.8) 17 (5.7) Back pain 13 (4.5) 10 (3.4) Nervous System Disorders Headache 27 (9.2) 16 (5.4) Respiratory, Thoracic and Mediastinal Disorders Dyspnea 17 (5.8) 13 (4.4) Adverse Reactions Leading to Treatment Discontinuation In clinical trials, adverse reactions leading to treatment discontinuation included headache, asthenia, dizziness, constipation, nausea, hypersensitivity reactions, intradialytic hypotension, pruritus, and pyrexia. Adverse reactions reported in the treatment extension period were similar to those observed in the randomized clinical studies.