Venofer 20mg/ml Inj, 10ml
It is used to treat anemia caused by low iron levels.
Drug Class
Antianemic agent
Pharmacologic Class
Iron replacement product
Pregnancy Category
Category B
FDA Approved
Oct 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Venofer is an iron medication given directly into your vein (intravenously) to treat iron deficiency anemia, especially if you have kidney disease and cannot take iron by mouth, or if oral iron doesn't work well for you. It helps your body make more red blood cells and carry oxygen.
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 guidelines provided. This drug 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.
In the event that 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.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Report any side effects immediately during or after the infusion.
- Do not take oral iron supplements unless directed by your doctor, as this medication provides sufficient iron.
- Maintain regular follow-up appointments for blood tests to monitor your iron levels and anemia.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg elemental iron (5 mL) administered as a slow intravenous infusion over 15 minutes, 1 to 3 times per week, for a total cumulative dose of 1000 mg. For hemodialysis patients, 100 mg after each dialysis session for 10 consecutive sessions.
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
Chronic Kidney Disease (CKD) on Hemodialysis:
100 mg slow IV infusion after each dialysis session for 10 consecutive sessions (cumulative 1000 mg).
CKD Not on Dialysis:
200 mg slow IV infusion on 5 different occasions over a 14-day period (cumulative 1000 mg).
CKD on Peritoneal Dialysis:
300 mg slow IV infusion on Day 1 and Day 15, then 400 mg slow IV infusion on Day 29 (cumulative 1000 mg).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants < 2 years of age.
Child:
For iron deficiency anemia in CKD patients 2 years of age and older: 0.5 mg/kg elemental iron administered as a slow IV infusion over 5-10 minutes, 3 times per week for 4 weeks (cumulative 600 mg). Maximum single dose 100 mg.
Adolescent:
Same as adult dosing for CKD patients (100 mg or 200 mg doses, cumulative 1000 mg).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, as it is commonly used in CKD patients.
Moderate:
No specific adjustment needed, as it is commonly used in CKD patients.
Severe:
No specific adjustment needed, as it is commonly used in CKD patients.
Dialysis:
Specific dosing protocols exist for hemodialysis and peritoneal dialysis patients (see adult dosing).
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution. Iron overload may exacerbate liver disease.
Pharmacology
Mechanism of Action
Iron sucrose is an aqueous complex of polynuclear iron (III)-hydroxide in sucrose. Following intravenous administration, iron sucrose dissociates into iron and sucrose. The iron component is transported to the bone marrow for erythropoiesis, where it is incorporated into hemoglobin. Iron is also stored in the reticuloendothelial system (e.g., liver, spleen, bone marrow) as ferritin or hemosiderin.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Peak serum iron levels are observed shortly after the end of infusion (e.g., 10 minutes after a 100 mg dose).
FoodEffect:
Not applicable for intravenous administration.
Distribution:
Vd:
Approximately 7.9 L (for the iron component)
ProteinBinding:
High, primarily to transferrin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6 hours (for the iron component of the complex); sucrose component has a half-life of approximately 3 hours.
Clearance:
Not readily quantifiable for iron as it is conserved in the body. Sucrose clearance is renal.
ExcretionRoute:
Iron is primarily conserved and recycled in the body. Small amounts are lost through shedding of cells (e.g., skin, GI tract). Sucrose is excreted renally.
Unchanged:
Not applicable for iron; sucrose is excreted largely unchanged.
Pharmacodynamics
OnsetOfAction:
Hemoglobin response typically observed within 2-4 weeks, with full effect over several weeks to months.
PeakEffect:
Peak increase in hemoglobin and iron stores occurs gradually over weeks to months.
DurationOfAction:
Iron stores can be replenished for several months, depending on ongoing iron loss and erythropoiesis.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Diarrhea
Upset stomach or vomiting
Dizziness or headache
Muscle cramps
Change in taste
Joint pain
Back pain
Nose or throat irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Diarrhea
Upset stomach or vomiting
Dizziness or headache
Muscle cramps
Change in taste
Joint pain
Back pain
Nose or throat irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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:
- Severe dizziness or lightheadedness
- Difficulty breathing, wheezing, or chest tightness
- Swelling of the face, lips, tongue, or throat
- Severe rash, itching, or hives
- Sudden severe back or chest pain
- Fever or chills
- Unusual weakness or fatigue
- Yellowing of the skin or eyes (jaundice)
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, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All 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 for you 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, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All 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 for you to do so.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and other laboratory tests should be conducted as directed by your doctor to monitor your condition. 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 to make an informed decision.
Overdose Information
Overdose Symptoms:
- Acute iron overload (e.g., hypotension, collapse, headache, vomiting, abdominal pain, diarrhea, metabolic acidosis, liver damage)
- Chronic iron overload (hemochromatosis) leading to organ damage (e.g., liver, heart, pancreas, joints, skin)
What to Do:
Immediately discontinue Venofer. Supportive measures should be instituted. Iron chelating agents (e.g., deferoxamine) may be considered in severe cases. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Oral iron preparations
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To assess the severity of anemia and monitor treatment response.
Timing: Prior to initiation of therapy.
Hematocrit (Hct)
Rationale: To assess the severity of anemia and monitor treatment response.
Timing: Prior to initiation of therapy.
Ferritin
Rationale: To assess body iron stores.
Timing: Prior to initiation of therapy.
Transferrin Saturation (TSAT)
Rationale: To assess the availability of iron for erythropoiesis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Vital Signs (blood pressure, heart rate)
Frequency: During and immediately after each infusion.
Target: Within patient's normal limits.
Action Threshold: Significant changes (e.g., hypotension, tachycardia) may indicate an infusion reaction; stop infusion and manage.
Hemoglobin (Hb)
Frequency: At least 4 weeks after the last dose of the cumulative course, or as clinically indicated.
Target: Individualized, aiming for improvement in anemia.
Action Threshold: Lack of response may indicate other causes of anemia or need for further iron.
Ferritin
Frequency: At least 4 weeks after the last dose of the cumulative course, or as clinically indicated.
Target: Individualized, often aiming for 200-500 ng/mL in CKD.
Action Threshold: Levels > 800 ng/mL or TSAT > 50% may indicate iron overload; consider withholding further iron.
Transferrin Saturation (TSAT)
Frequency: At least 4 weeks after the last dose of the cumulative course, or as clinically indicated.
Target: Individualized, often aiming for 20-50% in CKD.
Action Threshold: Levels > 50% may indicate iron overload; consider withholding further iron.
Symptom Monitoring
- Signs of hypersensitivity/anaphylaxis (e.g., rash, pruritus, urticaria, dyspnea, wheezing, hypotension, dizziness, loss of consciousness, angioedema)
- Signs of infusion reactions (e.g., headache, nausea, vomiting, muscle cramps, back pain, chest pain, chills, fever, flushing)
- Symptoms of iron overload (e.g., fatigue, joint pain, abdominal pain, liver dysfunction, heart problems, skin discoloration)
Special Patient Groups
Pregnancy
Category B. Studies in pregnant animals have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Iron deficiency anemia is common in pregnancy, and IV iron may be necessary for severe cases.
Trimester-Specific Risks:
First Trimester:
Generally avoided unless absolutely necessary due to limited data.
Second Trimester:
May be considered if oral iron is ineffective or not tolerated, and severe iron deficiency anemia persists.
Third Trimester:
May be considered if oral iron is ineffective or not tolerated, and severe iron deficiency anemia persists, especially if close to delivery.
Lactation
L3 (Moderately safe). Iron sucrose is minimally excreted into breast milk. The benefits of breastfeeding should be weighed against the potential risks. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the breastfed infant. Monitor for any unusual symptoms.
Pediatric Use
Safety and efficacy established for iron deficiency anemia in CKD patients 2 years of age and older. Dosing is weight-based. Not established for children younger than 2 years.
Geriatric Use
No specific dose adjustment is required. Elderly patients may be more susceptible to adverse reactions, particularly hypotension. Monitor for comorbidities and concomitant medications.
Clinical Information
Clinical Pearls
- Administer Venofer as a slow IV infusion to minimize the risk of hypotension and infusion-related reactions. Rapid infusion can increase the risk of adverse events.
- Monitor patients for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes after each infusion. Resuscitation equipment and personnel should be immediately available.
- Hypophosphatemia has been reported with IV iron products, particularly with high doses or frequent administration. Monitor phosphate levels if clinically indicated.
- Oral iron should be withheld during Venofer treatment to avoid potential interactions and ensure optimal iron utilization from the IV route.
- Iron sucrose is generally better tolerated than high molecular weight iron dextran, with a lower risk of anaphylaxis.
Alternative Therapies
- Oral iron supplements (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate)
- Other intravenous iron preparations (e.g., ferric carboxymaltose, ferumoxytol, iron dextran, ferric derisomaltose)
- Erythropoiesis-stimulating agents (ESAs) in combination with iron, for anemia of chronic kidney disease.
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300 per 100 mg vial per 100 mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require prior authorization)
General Drug Facts
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.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is recommended that you consult 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 emergency medical attention. Be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion, to facilitate prompt and effective treatment.
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.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is recommended that you consult 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 emergency medical attention. Be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion, to facilitate prompt and effective treatment.