Triferic AVNU

Last updated on RxList: 4/8/2020
Triferic AVNU Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Triferic AVNU?

Triferic AVNU (ferric pyrophosphate citrate injection) 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).

What Are Side Effects of Triferic AVNU?

Side effects of Triferic AVNU include:

Dosage for Triferic AVNU

The dose of Triferic AVNU (ferric pyrophosphate citrate injection) is an iron replacement product indicated for the is 6.75 mg iron (III) intravenously over 3 to 4 hours at each hemodialysis session via pre-dialyzer infusion line, post-dialyzer infusion line, or a separate connection to the venous blood line.

Triferic AVNU In Children

Safety and effectiveness of Triferic AVNU have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Triferic AVNU?

Triferic AVNU may interact with other medicines.

Tell your doctor all medications and supplements you use.

Triferic AVNU During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Triferic AVNU; it is unknown how it would affect a fetus. It is unknown if Triferic AVNU passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Triferic AVNU (ferric pyrophosphate citrate injection), for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Triferic AVNU Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • bleeding around your dialysis vein access point;
  • blue-colored skin, bulging purple-colored veins that you can see through your skin;
  • swelling in your arms, legs, or fingers;
  • unusual bleeding or bruising, coughing up blood;
  • a light-headed feeling, like you might pass out;
  • fever; or
  • pain or burning when you urinate.

Common side effects may include:

  • headache, dizziness;
  • swelling in your hands or feet;
  • weakness, tiredness;
  • muscle pain;
  • feeling short of breath; or
  • pain in your back, arms, or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Triferic AVNU (Ferric Pyrophosphate Citrate Injection)

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Triferic AVNU Professional Information

SIDE EFFECTS

The following clinically significant 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.

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]. 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 use 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 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: Adverse Reactions Reported in CRUISE1 and CRUISE 2 in at Least 3% of Patients Receiving Ferric Pyrophosphate Citrate Solution for Hemodialysis 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 (%)
Number of patients with at least one adverse reaction229 (78)223 (75)
General Disorders and Administration Site Conditions
Peripheral edema20 (7)11 (4)
Pyrexia13 (5)9 (3
Asthenia12 (4)9 (3)
Fatigue11 (4)6 (2)
Infections and Infestations
Urinary tract infection13 (5)4 (1)
Injury, Poisoning, and Procedural Complications
Procedural hypotension63 (22)57 (19)
Arteriovenous fistula thrombosis10 (3)6 (2)
Arteriovenous fistula site hemorrhage10 (3)5 (2)
Musculoskeletal and Connective Tissue Disorders
Muscle spasms28 (10)24 (8)
Pain in extremity20 (7)17 (6)
Back pain13 (5)10 (3)
Nervous System Disorders
Headache27 (9)16 (5)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea17 (6)13 (4)

Other Adverse Reactions

Less common adverse reactions occurring at a frequency of <3%:

  • Hypersensitivity reactions (0.3%)
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.

Read the entire FDA prescribing information for Triferic AVNU (Ferric Pyrophosphate Citrate Injection)

© Triferic AVNU Patient Information is supplied by Cerner Multum, Inc. and Triferic AVNU Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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