TRIFERIC SIDE EFFECTS

  • Generic Name: ferric pyrophosphate citrate solution, for addition to bicarbonate concentrate
  • Brand Name: Triferic
  • Drug Class: Iron Products
Last updated on MDtodate: 10/12/2022

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in the labeling:

  • Hypersensitivity Reactions.

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. 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 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.

Body System
Adverse Reaction
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.

 

SRC: NLM .