Venofer

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/27/2021
Venofer Side Effects Center

What Is Venofer?

Venofer (iron sucrose) Injection is an iron replacement product used to treat iron deficiency anemia in people with kidney disease. Venofer is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit).

What Are Side Effects of Venofer?

Common side effects of Venofer include:

Tell your doctor if you experience serious side effects of Venofer including:

  • abdominal pain,
  • chest pain,
  • irregular heartbeat (arrhythmias),
  • pressure in the chest,
  • severe headache and blurred vision (hypertension), or
  • problems with your dialysis access site (graft).

Dosage for Venofer?

Venofer is only administered intravenously by slow injection or by infusion. Dose is determined by whether the patient is on dialysis and what type of dialysis.

What Drugs, Substances, or Supplements Interact with Venofer?

Venofer may interact with iron supplements or other iron-based oral medications, such as ferrous fumarate, ferrous gluconate, and ferrous sulfate, and others. Tell your doctor all medications and supplements you use.

Venofer During Pregnancy and Breastfeeding

Venofer should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Venofer (iron sucrose) 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.

QUESTION

The only purpose of the kidneys is to filter blood. See Answer
Venofer Consumer Information

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

Tell your caregivers right away if you have:

  • problems with your dialysis vein access point;
  • chest pain;
  • high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • low blood pressure--a light-headed feeling, like you might pass out; or
  • signs of inflammation in the lining of your stomach--pain or swelling, bloating, nausea, vomiting, loss of appetite, diarrhea, fever.

Common side effects may include:

  • fever, cold or flu symptoms (sore throat, cough, stuffy nose, sneezing);
  • high or low blood pressure;
  • headache, dizziness;
  • nausea, vomiting, diarrhea;
  • muscle or joint pain, back pain;
  • pain or swelling in an arm or leg;
  • itching; or
  • bruising or irritation where the medicine was injected.

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 Venofer (Iron Sucrose Injection)

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow
Venofer Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

Adverse Reactions In Clinical Trials

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.

Adverse Reactions In Adult Patients With CKD

The frequency of adverse reactions associated with the use of Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDDCKD. Adverse reactions reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Venofer exceeds the rate for comparator are listed by indication in Table 1. Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered. Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks.

Table 1: Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator

Body System/ Adverse Reactions HDD-CKD NDD-CKD PDD-CKD
Venofer
(N=231) %
Venofer
(N=139) %
Oral Iron
(N=139) %
Venofer
(N=75) %
EPO* Only
(N=46) %
Subjects with any adverse reaction 78.8 76.3 73.4 72.0 65.2
Ear and Labyrinth Disorders
Ear Pain 0 2.2 0.7 0 0
Eye Disorders
Conjunctivitis 0.4 0 0 2.7 0
Gastrointestinal Disorders
Abdominal pain 3.5 1.4 2.9 4.0 6.5
Diarrhea 5.2 7.2 10.1 8.0 4.3
Dysgeusia 0.9 7.9 0 0 0
Nausea 14.7 8.6 12.2 5.3 4.3
Vomiting 9.1 5.0 8.6 8.0 2.2
General Disorders and Administration Site Conditions
Asthenia 2.2 0.7 2.2 2.7 0
Chest pain 6.1 1.4 0 2.7 0
Feeling abnormal 3.0 0 0 0 0
Infusion site pain or burning 0 5.8 0 0 0
Injection site extravasation 0 2.2 0 0 0
Peripheral edema 2.6 7.2 5.0 5.3 10.9
Pyrexia 3.0 0.7 0.7 1.3 0
Infections and Infestations
Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis 2.6 2.2 4.3 16.0 4.3
Injury, Poisoning and Procedural Complications
Graft complication 9.5 1.4 0 0 0
Metabolism and Nutrition Disorders
Fluid overload 3.0 1.4 0.7 1.3 0
Gout 0 2.9 1.4 0 0
Hyperglycemia 0 2.9 0 0 2.2
Hypoglycemia 0.4 0.7 0.7 4.0 0
Musculoskeletal and Connective Tissue Disorders
Arthralgia 3.5 1.4 2.2 4.0 4.3
Back pain 2.2 2.2 3.6 1.3 4.3
Muscle cramp 29.4 0.7 0.7 2.7 0
Myalgia 0 3.6 0 1.3 0
Pain in extremity 5.6 4.3 0 2.7 6.5
Nervous System Disorders
Dizziness 6.5 6.5 1.4 1.3 4.3
Headache 12.6 2.9 0.7 4.0 0
Respiratory, Thoracic and Mediastinal Disorders
Cough 3.0 2.2 0.7 1.3 0
Dyspnea 3.5 5.8 1.4 1.3 2.2
Nasal congestion 0 1.4 2.2 1.3 0
Skin and Subcutaneous Tissue Disorders
Pruritus 3.9 2.2 4.3 2.7 0
Vascular Disorders
Hypertension 6.5 6.5 4.3 8.0 6.5
Hypotension 39.4 2.2 0.7 2.7 2.2
* EPO=Erythropoietin

One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had prior other intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Venofer there were no occurrences of adverse reactions that precluded further use of Venofer [see WARNINGS AND PRECAUTIONS].

Adverse Reactions In Pediatric Patients With CKD (ages 2 years and older)

In a randomized, open-label, dose-ranging trial for iron maintenance treatment with Venofer in pediatric patients with CKD on stable erythropoietin therapy [see Clinical Studies], at least one adverse reaction was experienced by 57% (27/47) of the patients receiving Venofer 0.5 mg/kg, 53% (25/47) of the patients receiving Venofer 1 mg/kg, and 55% (26/47) of the patients receiving Venofer 2 mg/kg.

A total of 5 (11%) subjects in the Venofer 0.5 mg/kg group, 10 (21%) patients in the Venofer 1 mg/kg group, and 10 (21%) patients in the Venofer 2 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).

Adverse Reactions From Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Venofer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by > 1% were: cardiac failure congestive, sepsis and dysgeusia.

  • Immune system disorders: anaphylactic-type reactions, angioedema
  • Psychiatric disorders: confusion
  • Nervous system disorders: convulsions, collapse, light-headedness, loss-of-consciousness
  • Cardiac disorders: bradycardia
  • Vascular disorders: shock
  • Respiratory, thoracic and mediastinal disorders: bronchospasm, dyspnea
  • Musculoskeletal and connective tissue disorders: back pain, swelling of the joints
  • Renal and urinary disorders: chromaturia
  • General disorders and administration site conditions: hyperhidrosis

Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection. Reactions have occurred following the first dose or subsequent doses of Venofer. Symptoms may respond to intravenous fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms.

Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.

Read the entire FDA prescribing information for Venofer (Iron Sucrose Injection)

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

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