Venofer 20mg/ml Inj, 5ml
It is used to treat anemia caused by low iron levels.
Drug Class
Antianemic agent
Pharmacologic Class
Iron replacement product, Parenteral iron
Pregnancy Category
Category B
FDA Approved
Oct 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iron sucrose is an iron medicine given directly into your vein (intravenously) to treat low iron levels (iron deficiency anemia). It helps your body make more red blood cells, which carry oxygen throughout your body. It is commonly used in people with kidney disease.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all provided guidelines. This medication is administered intravenously over a specified period.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Maintain a balanced diet, but understand that dietary iron alone is often insufficient to correct severe iron deficiency.
- Report any side effects or allergic reactions immediately during or after the infusion.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Total cumulative dose of 1000 mg of iron, administered in divided doses. For hemodialysis-dependent CKD patients: 100 mg IV undiluted or diluted in 100 mL NS over 2-5 minutes or 15 minutes respectively, administered during a dialysis session, 3 times per week for 10 sessions.
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
CKD on Hemodialysis:
100 mg IV during dialysis session, 3 times per week for 10 sessions (total 1000 mg).
CKD Not on Dialysis:
200 mg IV over 2-5 minutes on 5 different occasions within a 14-day period (total 1000 mg).
CKD on Peritoneal Dialysis:
300 mg IV over 1.5 hours on days 1 and 15, then 400 mg IV over 2.5 hours on day 29 (total 1000 mg).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For iron deficiency anemia in CKD patients 2-12 years of age: 0.5 mg/kg (maximum 100 mg) IV 3 times per week for 10 doses (total 500 mg).
Adolescent:
For iron deficiency anemia in CKD patients 12-16 years of age: 100 mg IV 3 times per week for 10 doses (total 1000 mg).
Dose Adjustments
Renal Impairment:
Mild:
Dosing is specifically for CKD patients; no additional adjustment needed beyond standard CKD dosing regimens.
Moderate:
Dosing is specifically for CKD patients; no additional adjustment needed beyond standard CKD dosing regimens.
Severe:
Dosing is specifically for CKD patients; no additional adjustment needed beyond standard CKD dosing regimens.
Dialysis:
Specific dosing regimens provided for hemodialysis and peritoneal dialysis patients.
Hepatic Impairment:
Mild:
No specific dose adjustment provided; use with caution.
Moderate:
No specific dose adjustment provided; use with caution.
Severe:
No specific dose adjustment provided; use with caution.
Pharmacology
Mechanism of Action
Iron sucrose dissociates into iron and sucrose. The iron component is then transported to the bone marrow for erythropoiesis, incorporated into hemoglobin, or stored as ferritin. It replenishes iron stores necessary for red blood cell formation and oxygen transport.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediately after infusion (for serum iron levels)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 3 L (similar to plasma volume)
ProteinBinding:
High (primarily to transferrin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6 hours (for iron component in plasma)
Clearance:
Not readily quantifiable as iron is incorporated into physiological processes; sucrose is renally cleared.
ExcretionRoute:
Primarily via incorporation into red blood cells and iron stores; minimal renal excretion of iron.
Unchanged:
Not applicable for iron; sucrose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid increase in serum iron levels immediately after infusion; clinical effect (hemoglobin increase) typically observed within weeks.
PeakEffect:
Hemoglobin increase typically seen within 2-4 weeks after initiation of therapy.
DurationOfAction:
Effect on iron stores can last for several months, depending on the patient's iron status and ongoing losses.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with 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 list is not exhaustive, and you may experience other 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with 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 list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Signs of a severe allergic reaction: rash, itching, hives, swelling of your face, lips, tongue, or throat, difficulty breathing, dizziness, lightheadedness, chest pain, shortness of breath, or feeling like you might pass out.
- Severe pain, swelling, or discoloration at the injection site.
- Headache, nausea, diarrhea, muscle cramps.
Before Using This Medicine
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 symptoms you experienced as a result of the allergy.
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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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 symptoms you experienced as a result of the allergy.
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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. As directed by your doctor, regularly have your blood work and other laboratory tests monitored. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute iron toxicity: hypotension, circulatory collapse, abdominal pain, vomiting, diarrhea, metabolic acidosis, liver damage, coma.
What to Do:
Supportive care, monitoring of vital signs and iron levels. In severe cases, chelation therapy (e.g., deferoxamine) may be considered. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
- Oral iron preparations (should be discontinued before IV iron administration to avoid decreased absorption of oral iron and potential for iron overload)
Moderate Interactions
- ACE inhibitors (potential for increased risk of hypersensitivity reactions, though evidence is limited)
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To assess the severity of anemia and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Hematocrit (Hct)
Rationale: To assess the severity of anemia and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Serum Ferritin
Rationale: To assess body iron stores and confirm iron deficiency.
Timing: Prior to initiation of therapy.
Transferrin Saturation (TSAT)
Rationale: To assess the amount of iron available for erythropoiesis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: At least 1 week after the last dose of the course, then periodically (e.g., monthly or every 3 months) as clinically indicated.
Target: > 11 g/dL (target may vary based on guidelines and patient condition)
Action Threshold: If Hb is not improving or remains below target, consider further investigation or repeat course.
Serum Ferritin
Frequency: At least 1 week after the last dose of the course, then periodically as clinically indicated.
Target: > 100 ng/mL (target may vary based on guidelines and patient condition)
Action Threshold: If ferritin remains low, consider repeat course or alternative therapy.
Transferrin Saturation (TSAT)
Frequency: At least 1 week after the last dose of the course, then periodically as clinically indicated.
Target: > 20% (target may vary based on guidelines and patient condition)
Action Threshold: If TSAT remains low, consider repeat course or alternative therapy.
Vital signs (Blood Pressure, Heart Rate)
Frequency: During and immediately after infusion (monitor for at least 30 minutes post-infusion).
Target: Stable
Action Threshold: Significant changes (e.g., hypotension, tachycardia) or signs of allergic reaction require immediate intervention.
Symptom Monitoring
- Signs of hypersensitivity/allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing, dizziness, lightheadedness, chest pain, shortness of breath, collapse)
- Injection site reactions (e.g., pain, swelling, discoloration)
- Headache
- Nausea
- Diarrhea
- Muscle cramps
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Limited human data suggest no increased risk of major birth defects. Use if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified.
Lactation
Iron is naturally present in breast milk. Excretion of iron sucrose into breast milk is minimal. Considered compatible with breastfeeding, as the amount transferred to the infant is unlikely to cause adverse effects.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Safety and efficacy have been established for children 2 years of age and older with CKD. Dosing is weight-based for younger children. Safety and efficacy not established in children younger than 2 years of age.
Geriatric Use
No specific dose adjustment is generally required for elderly patients. However, use with caution due to the higher likelihood of concomitant diseases and polypharmacy. Monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Administer slowly to minimize the risk of hypersensitivity reactions. Observe patients for at least 30 minutes after infusion for signs of hypersensitivity.
- Do not mix iron sucrose with other medications or add to parenteral nutrition solutions.
- Not for intramuscular use; intramuscular administration can cause pain, staining of the skin, and poor absorption.
- Oral iron preparations should be discontinued before initiating IV iron sucrose therapy.
- Ensure adequate iron stores are depleted before initiating therapy; do not administer to patients with iron overload.
Alternative Therapies
- Other intravenous iron preparations (e.g., ferric carboxymaltose, ferumoxytol, iron dextran, ferric derisomaltose)
- Oral iron supplements (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate)
- Erythropoiesis-stimulating agents (ESAs) in combination with iron therapy (for specific indications like anemia of CKD)
Cost & Coverage
Average Cost:
Varies widely per 100 mg/5 mL vial
Generic Available:
Yes
Insurance Coverage:
Often covered under medical benefit for specific indications (e.g., CKD). May be Tier 2 or 3 for pharmacy benefit.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.