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Venofer

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Venofer

Venofer Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Venofer (iron sucrose) Injection is used to treat iron deficiency anemia in people with kidney disease. It is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit). It is an iron replacement product. Common side effects include muscle cramps, nausea, vomiting, strange taste in the mouth, diarrhea, constipation, headache, cough, back pain, joint pain, dizziness, swelling of the arms/legs, or pain, swelling, or redness at the injection site.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Venofer in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have a serious side effect such as:

  • chest pain;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • trouble breathing; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • muscle cramps;
  • weakness, tired feeling;
  • dizziness, anxiety, headache;
  • nausea, vomiting, stomach pain;
  • diarrhea, constipation;
  • ear pain;
  • sore throat, sinus pain or congestion;
  • decreased sense of taste;
  • joint pain; or
  • pain, swelling, burning, or irritation around the IV needle.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Venofer Overview - Patient Information: Side Effects

SIDE EFFECTS: Muscle cramps, nausea, vomiting, strange taste in the mouth, diarrhea, constipation, headache, cough, back pain, joint pain, dizziness, or swelling of the arms/legs may occur. Pain, swelling, or redness at the injection site may occur. If these effects continue or worsen, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Severe dizziness or fainting (hypotension) may occur while you are receiving IV iron. This may be helped by giving the medication more slowly or at a lower dose. Follow your doctor's directions carefully.

Tell your doctor right away if you have any serious side effects, including: abdominal pain, chest pain, irregular heartbeat (arrhythmias), pressure in the chest, severe headache and blurred vision (hypertension), problems with your dialysis access site (graft).

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Venofer (Iron Sucrose Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Venofer FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions associated with Venofer are described in other sections [See WARNINGS AND PRECAUTIONS].

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 PDD-CKD. Treatment-emergent 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: Treatment-Emergent Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator

Adverse Reactions (Preferred Term) 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 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 6.5
  Diarrhea 5.2 7.2 10.1 8 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 8.6 8 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
  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 5.3 10.9
  Pyrexia 3 0.7 0.7 1.3 0
Infections and Infestations
  Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis 2.6 2.2 4.3 16 4.3
Injury, Poisoning and Procedural Complications
  Graft complication 9.5 1.4 0 0 0
Metabolism and Nutrition Disorders  
  Fluid overload 3 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
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 3.5 1.4 2.2 4 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 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 WARNING 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 treatment-emergent 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 1.0 mg/kg, and 55% (26/47) of the patients receiving Venofer 2.0 mg/kg.

A total of 5 (11%) subjects in the Venofer 0.5 mg/kg group, 10 (21%) patients in the Venofer 1.0 mg/kg group, and 10 (21%) patients in the Venofer 2.0 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common treatment-emergent 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%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).

Adverse Reactions from Post-Marketing Experience

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.

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: Anaphylactic-type reactions, shock, loss of consciousness, collapse, bronchospasm, dyspnea, convulsions, lightheadedness, confusion, angioedema, swelling of the joints, hyperhidrosis, back pain, bradycardia, and chromaturia.

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 IV 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) »

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Venofer - User Reviews

Venofer User Reviews

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Here is a collection of user reviews for the medication Venofer sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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