IMPORTANT SAFETY INFORMATION
Venofer® (iron sucrose injection, USP) is available by prescription only. Ask your doctor or healthcare provider if Venofer is the right choice for you.
What is Venofer? Venofer® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric (2 years of age and older) patients with chronic kidney disease (CKD), and is administered only by or under the supervision of your healthcare provider. The dosing for iron replacement treatment in pediatric patients less than 2 years old with Peritoneal or Hemodialysis-Dependent CKD or Non-Dialysis-Dependent CKD have not been established.
You should not receive Venofer if you have known allergies to iron sucrose. Notify your healthcare provider of all medical conditions and any medications, including supplements you are taking.
WARNINGS/CAUTIONS: Serious hypersensitivity reactions, including anaphylactic-type reactions (itching, hives, swelling, wheezing, difficulty breathing, fainting and/or other allergy symptoms), some of which have been life threatening and fatal, have happened in patients receiving Venofer. Venofer may cause significant hypotension (decreased blood pressure). Your healthcare provider will watch you closely for 30 minutes after each dose.
Call your healthcare provider or get medical help right away if you have symptoms of an allergic reaction, including but not limited to rash, chest pain, cough, dizziness, passing out, shortness of breath, sweating or throat tightness.
Excessive amounts of Venofer may lead to a condition called iron overload, which may be harmful.
All patients receiving Venofer require periodic blood tests to monitor the amount of iron in the blood. Venofer may reduce the absorption of iron preparations taken by mouth.
Notify your healthcare provider if you are pregnant, or planning to get pregnant or breastfeeding. There may be risks to the mother and fetus associated with untreated IDA in pregnancy.
SIDE EFFECTS: In adult patients, the most common side effects (≥2%) include diarrhea, upset stomach, throwing up, headache, dizziness, hypotension, pruritus (itching), pain in extremity, arthralgia (joint pain), back pain, muscle cramp, injection site reactions, chest pain and peripheral edema (swelling).
In pediatric patients the most common side effects (>2%) are headache, viral respiratory tract infection, peritonitis, upset stomach, throwing up, fever, dizziness, cough, arteriovenous fistula thrombosis, hypotension and hypertension (increased blood pressure).
These are not all the side effects that may occur; contact your healthcare provider if you have questions.
Potential injection site discoloration has happened. Notify your healthcare provider of any irritation at the injection site.
The information provided is not intended to replace your healthcare provider's medical advice. For additional information, contact your healthcare provider.
You are encouraged to report side effects 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.