Venofer 20mg/ml Inj, 2.5ml

Iron sucrose is a complex of polynuclear iron (III)-hydroxide in sucrose. Following intravenous administration, the iron sucrose complex is thought to be taken up by the reticuloendothelial system (RES), which then releases iron. The iron is then transported to the bone marrow for erythropoiesis, where it is incorporated into hemoglobin. It replenishes body iron stores and is used to treat iron deficiency anemia.

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain
Swelling in the arms or legs
Pain in the arms or legs
Irritation at the injection site

Your doctor may monitor you closely for a period of time after administering this medication. If you experience any of the following symptoms, contact your doctor immediately:

Chest pain
Cough or the need to cough
Dizziness
Passing out
Shortness of breath
Sweating
Throat tightness

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
Dizziness or headache
Muscle cramps
Change in taste
Joint pain
Back pain
Nose or throat irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Having too much iron in your body
+ Anemia caused by a factor other than low iron levels

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood tests and other laboratory examinations as directed by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Oral iron preparations (concurrent administration may reduce absorption of oral iron)

• Signs of hypersensitivity/anaphylaxis (e.g., rash, itching, hives, shortness of breath, wheezing, chest tightness, swelling of face/lips/tongue/throat)
• Hypotension (dizziness, lightheadedness, fainting)
• Headache
• Nausea, vomiting, diarrhea, abdominal pain
• Muscle cramps, back pain, joint pain
• Peripheral edema
• Injection site reactions (e.g., pain, swelling, redness)

Venofer is used in pregnant women with iron deficiency anemia when oral iron is ineffective or not tolerated. Available data from postmarketing reports are insufficient to assess a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies show no evidence of harm to the fetus. Clinical considerations suggest that untreated iron deficiency anemia in pregnancy can lead to adverse maternal and fetal outcomes.

Limited data suggest that iron sucrose is excreted in human milk. However, the amount of iron transferred to breast milk is likely low and unlikely to cause adverse effects in a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Venofer and any potential adverse effects on the breastfed child from Venofer or from the underlying maternal condition.

Safety and efficacy have been established in pediatric patients 2 years of age and older with iron deficiency anemia and CKD. Dosing is weight-based. Safety and efficacy in pediatric patients less than 2 years of age have not been established.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, caution should be exercised when administering the drug to elderly patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Administer slowly to minimize risk of hypotension and hypersensitivity reactions. For 100 mg dose, infuse over at least 15 minutes.
• Monitor patients for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following each Venofer infusion.
• Do not mix Venofer with other medications or add to parenteral nutrition solutions.
• Venofer should only be administered intravenously; do not administer intramuscularly or subcutaneously.
• Patients should be advised that iron sucrose may cause a temporary brown discoloration of the urine.

• Oral iron supplements (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate)
• Other intravenous iron preparations (e.g., ferric carboxymaltose, ferumoxytol, iron dextran, ferric derisomaltose, ferric pyrophosphate citrate)
• Erythropoiesis-stimulating agents (ESAs) in combination with iron, for anemia of CKD.

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs; your pharmacist can provide information on these programs. Some medications may have additional patient information leaflets; consult your pharmacist if you have questions. If you have any concerns or questions about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it happened to ensure prompt and effective treatment.