Venofer Dosing and Administration
For Intravenous Use Solely
INDICATION AND USAGE
Venofer® (iron sucrose) injection, USP is indicated for the remedy of iron deficiency anemia (IDA) in sufferers with continual kidney illness (CKD).
IMPORTANT SAFETY INFORMATION
DOSAGE AND ADMINISTRATION
Pediatric Sufferers (2 Years of Age and Older)
The dosing for iron alternative remedy in pediatric sufferers with Peritoneal or Hemodialysis-Dependent – CKD or Non-Dialysis Dependent CKD haven’t been established.
Identified hypersensitivity to Venofer.
WARNINGS AND PRECAUTIONS
Severe hypersensitivity reactions, together with anaphylactic-type reactions, a few of which have been life-threatening and deadly, have been reported in sufferers receiving Venofer. Sufferers might current with shock, clinically vital hypotension, lack of consciousness and/or collapse. If hypersensitivity reactions or indicators of intolerance happen throughout administration, cease Venofer instantly. Monitor sufferers for indicators and signs of hypersensitivity throughout and after Venofer administration for not less than half-hour and till clinically secure following completion of the infusion. Solely administer Venofer when personnel and therapies are instantly out there for the remedy of great hypersensitivity reactions. Most reactions related to intravenous iron preparations happen inside half-hour of the completion of the infusion.
Venofer might trigger clinically vital hypotension. Monitor for indicators and signs of hypotension following every administration of Venofer. Hypotension following administration of Venofer could also be associated to fee of administration and/or whole dose delivered.
Extreme remedy with parenteral iron can result in extra storage of iron with the opportunity of iatrogenic hemosiderosis. All grownup and pediatric sufferers receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Don’t administer Venofer to sufferers with proof of iron overload. Transferrin saturation (TSAT) values enhance quickly after intravenous administration of iron sucrose; don’t carry out serum iron measurements for not less than 48 hours after intravenous dosing.
Grownup Sufferers: The commonest opposed reactions (≥2%) embrace diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, ache in extremity, arthralgia, again ache, muscle cramp, injection web site reactions, chest ache and peripheral edema.
Pediatric Sufferers: The commonest opposed reactions (≥2%) are headache, respiratory tract viral an infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension and hypertension.
Put up-Advertising and marketing Expertise
As a result of these reactions are reported voluntarily from a inhabitants of unsure measurement, it isn’t all the time potential to reliably estimate their frequency or set up a causal relationship to drug publicity. In post-marketing security research of Venofer in 1,051 sufferers with HDD-CKD, opposed reactions reported by >1% had been cardiac failure congestive, sepsis and dysgeusia.
- Immune system issues: anaphylactic-type reactions, angioedema
- Psychiatric issues: confusion
- Nervous system issues: convulsions, collapse, light-headedness, loss-of-consciousness
- Cardiac issues: bradycardia
- Vascular issues: shock
- Respiratory, thoracic and mediastinal issues: bronchospasm, dyspnea
- Musculoskeletal and connective tissue issues: again ache, swelling of the joints
- Renal and urinary issues: chromaturia
- Common issues and administration web site circumstances: hyperhidrosis
Signs related to Venofer whole dosage or infusing too quickly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, belly and muscle ache, edema and cardiovascular collapse. These opposed reactions have occurred as much as half-hour after the administration of Venofer injection. Reactions have occurred following the primary dose or subsequent doses of Venofer. Slowing the infusion fee might alleviate signs.
Injection web site discoloration has been reported following extravasation. Guarantee secure intravenous entry to keep away from extravasation.
Venofer might scale back the absorption of concomitantly administered oral iron preparations.
USE IN SPECIFIC POPULATIONS
Being pregnant: Danger Abstract-Medical Issues
Untreated IDA in being pregnant is related to opposed maternal outcomes corresponding to post-partum anemia. Antagonistic being pregnant outcomes related to IDA embrace elevated danger for preterm supply and low start weight.
Extreme opposed reactions together with circulatory failure (extreme hypotension, shock together with within the context of anaphylactic response) might happen in pregnant ladies with parenteral iron merchandise (corresponding to Venofer) which can trigger fetal bradycardia, particularly in the course of the second and third trimester.
Dose administration to an aged affected person ought to be cautious, reflecting the better frequency of decreased hepatic, renal or cardiac operate, and of concomitant illness or different drug remedy.
No information can be found concerning overdosage of Venofer in people. Extreme dosages of Venofer might result in accumulation of iron in storage websites probably resulting in hemosiderosis. Don’t administer Venofer to sufferers with iron overload.
For added Security Data, please see Full Prescribing Data.
You’re inspired to report Antagonistic Drug Occasions to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.