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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. 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 (6.1) ] Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving ferric pyrophosphate citrate in two randomized clinical trials. 5.2 Iron Laboratory Testing Determine iron status on pre-dialysis blood samples. Post-dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
warnings and cautions
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 (6.1) ] Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving ferric pyrophosphate citrate in two randomized clinical trials.
6. ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions. [ see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥3%) are: 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. (6.1) 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. The safety of ferric pyrophosphate citrate injection, for intravenous use, has been established based on adequate and well-controlled studies of ferric pyrophosphate citrate solution for hemodialysis [ see Clinical Studies (14) ]. Below is a display of the adverse reactions of ferric pyrophosphate citrate solution for hemodialysis in these adequate and well-controlled studies. The safety of ferric pyrophosphate citrate solution for hemodialysis was evaluated in 292 patients in two randomized, placebo-controlled clinical trials (CRUISE 1 (NCT01320202) and CRUISE 2 (NCT01322347)) who were administered ferric pyrophosphate citrate solution for hemodialysis usefor 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 reactions occurring in 3% or greater of patients treated with ferric pyrophosphate citrate solution for hemodialysis use in the randomized clinical trials are listed in Table 1 . Table 1. Table 1: Adverse Reactions Reported in Two Clinical Trials in at Least 3% of Patients Receiving Ferric Pyrophoshate Citrate Solution for Hmodialysis Use and at an Incidence at Least 1% Greater than Placebo Body System Adverse Reaction Ferric Pyrophosphate Citrate Solution for Hemodialysis Use N=292 n (%) Placebo N=296 n (%) Numberof patients with at least one adverse reaction 229 (78) 223 (75) General Disorders and Administration Site Reactions Peripheral edema 20 (7) 11 (4) Pyrexia 13 (5) 9 (3) Asthenia 12 (4) 9 (3) Fatigue 11 (4) 6 (2) Infections and Infestations Urinary tract infection 13 (5) 4 (1) Injury, Poisoning and Procedural Complications Procedural hypotension 63 (22) 57 (19) Arteriovenous fistula thrombosis 10 (3) 6 (2) Arteriovenous fistula site hemorrhage 10 (3) 5 (2) Musculoskeletal and Connective Tissue Disorders Muscle spasms 28 (10) 24 (8) Pain in extremity 20 (7) 17 (6) Back pain 13 (5) 10 (3) Nervous System Disorders Headache 27 (9) 16 (5) Respiratory, Thoracic and Mediastinal Disorders Dyspnea 17 (6) 13 (4) Other Adverse Reactions: Less common adverse reactions occurring at a frequency of <3%: Hypersensitivity Reactions. [see Warnings and Precautions (5.1) ] Adverse Reactions Leading to Treatment Discontinuation: In clinical trials,adverse reactionsleading to treatment discontinuation include headache, asthenia, dizziness, constipation,nausea,hypersensitivity reactions, intradialytic hypotension, pruritis and pyrexia.