Venofer
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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). 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 dialysisaccess site (graft).
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.
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)
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
Table 1. Adverse Reactions Reported in ⥠2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator
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 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 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 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%), 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)
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© 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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