Triferic

TRIFERIC- ferric pyrophosphate citrate solution
TRIFERIC- ferric pyrophosphate citrate powder
Rockwell Medical, Inc

1 INDICATIONS AND USAGE

Triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

1.1 Limitation of Use

Triferic is not intended for use in patients receiving peritoneal dialysis.

Triferic has not been studied in patients receiving home hemodialysis.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Inspect Triferic solution in ampules for signs of precipitation prior to mixing with the bicarbonate concentrate. Triferic solution should appear slightly yellow-green in color.

Triferic solution or powder should only be added to the bicarbonate concentrate and should NOT be added to acid concentrate mixtures.

Add Triferic solution or powder to bicarbonate concentrate used for the generation of hemodialysate. The concentration of iron (III) in the final hemodialysate is 2 micromolar (110 mcg/L).

  • Add one 5 mL ampule of Triferic solution to 2.5 gallons (9.46 liters) of bicarbonate concentrate. Multiple 5 mL ampules can be added to the master bicarbonate mix at each center at a ratio of one (1) ampule for each 2.5 gallons (9.46 liters) of bicarbonate concentrate.
  • Add one packet of Triferic powder to 25 gallons (94.6 liters) of bicarbonate concentrate. Multiple packets can be added to the master bicarbonate mix and distribution system at each center at a ratio of one (1) 272 mg packet for each 25 gallons of bicarbonate concentrate.

Administer Triferic to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.

Dosage of Triferic solution is expressed as mg of iron (III). Each mL of Triferic solution contains 5.44 mg of iron as iron(III).

Hemodialysis bicarbonate solutions should be used within 24 hours of the preparation of the bicarbonate concentrate mixture.

3 DOSAGE FORMS AND STRENGTHS

Injection: 27.2 mg iron(III) per 5 mL (5.44 mg iron(III) per mL) clear slightly yellow-green solution in single dose ampule.

For Injection: 272 mg iron(III) of ferric pyrophosphate citrate as slightly yellow-green powder Packet

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

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 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:

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.

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