Ferric Pyrophosphate Citrate Solution, for Addition to Bicarbonate Concentrate
Name: Ferric Pyrophosphate Citrate Solution, for Addition to Bicarbonate Concentrate
Side effects
The following adverse reactions are described below and elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS].
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]. 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) |
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.
Warnings
Included as part of the PRECAUTIONS section.
Overdose
No data are available regarding overdosage of Triferic in humans.