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VENOFER is a brand name for Iron, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VENOFER® (Iron Sucrose Injection) is indicated in the treatment of iron deficiency anemia in the following patients: • non-dialysis-dependent chronic kidney disease (NDD-CKD) patients receiving an erythropoietin • non-dialysis-dependent chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin •…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The dosage of VENOFER® is expressed in terms of mg of elemental iron. Each 5 mL vial contains 100 mg of elemental iron (20 mg/mL). • Most CKD patients will require a minimum cumulative dose of 1000 mg of elemental iron, administered over sequential sessions, to achieve a favourable hemoglobin or hematocrit response.
Patients may then continue to require therapy at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit and iron storage parameters within acceptable limits (ferritin, TSAT). • Should hypersensitivity reactions or signs of intolerance occur, stop VENOFER immediately.
Monitor patients for signs and symptoms of hypersensitivity during and after VENOFER administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer VENOFER when personnel and resuscitative interventions are immediately available for the treatment of serious hypersensitivity reactions (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Recommended Adult Dosage: • Non-Dialysis-Dependent Chronic Kidney Disease Patients (NDD-CKD): VENOFER is administered as a total cumulative dose of 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
5 - 4 hours on day 1 and day 14; hypotension occurred in 2 of 30 patients treated. Patients weighing less than 70 kg may require a longer infusion time. 9% NaCl over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1000 mg.
5 hours 14 days later. 9% NaCl. 4 Administration VENOFER must only be administered intravenously by slow injection or infusion. 9% NaCl is used). 9% NaCl is used). 9% NaCl is used). 9% NaCl is used). 9% NaCl When prepared as an infusion, use immediately.
Do not store. 2 Recommended Dosage and Dosage Adjustment. Do not mix VENOFER with other medications or add to parenteral nutrient solutions for intravenous infusion. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Discard unused portion (see 11 STORAGE, STABILITY AND DISPOSAL). 5 Missed Dose If a planned dose of VENOFER is missed, it should be administered as soon as possible.
). Should hypersensitivity reactions or signs of intolerance occur, stop VENOFER immediately. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion. Monitor patients for signs and symptoms of hypersensitivity during and after VENOFER administration for at least 30 minutes and until clinically stable following completion of the infusion.
Only administer VENOFER when personnel and resuscitative interventions are immediately available for the treatment of serious hypersensitivity reactions (see 4 DOSAGE AND ADMINISTRATION).
Reproductive Health:
Female and Male Potential • Fertility VENOFER at IV doses up to 15 mg iron/kg/dose (about 10 times the maximum recommended human dose for a 70 kg person) given three times a week was found to have no effect on fertility and reproductive performance of male and female rats.
1 Pregnant Women There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, VENOFER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Teratology studies performed in rats at IV doses up to 13 mg iron/kg/day (more than 9 times the maximum recommended human dose for a 70 kg person) and rabbits at IV doses up to 13 mg iron/kg on alternate days (approximately 9 times the maximum recommended human dose for a 70 kg person) PrVENOFER® Iron Sucrose Injection Page 9 of 31 have not revealed definitive evidence of impaired fertility.
Fetal growth effects at these doses appeared related to low maternal food consumption and low body weight gain. When iron sucrose was administered at deliberate overdoses to rabbit dams (up to 215 mg/kg/day) marked fetal/placental iron overload was noted.
). 2 Recommended Dose and Dosage Adjustment Recommended Adult Dosage: • Non-Dialysis-Dependent Chronic Kidney Disease Patients (NDD-CKD): VENOFER is administered as a total cumulative dose of 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
5 - 4 hours on day 1 and day 14; hypotension occurred in 2 of 30 patients treated. Patients weighing less than 70 kg may require a longer infusion time. 9% NaCl over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1000 mg.
5 hours 14 days later. 9% NaCl. 4 Administration VENOFER must only be administered intravenously by slow injection or infusion. 9% NaCl is used). 9% NaCl is used). 9% NaCl is used). 9% NaCl is used). 9% NaCl When prepared as an infusion, use immediately.
Do not store. 2 Recommended Dosage and Dosage Adjustment. Do not mix VENOFER with other medications or add to parenteral nutrient solutions for intravenous infusion. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Discard unused portion (see 11 STORAGE, STABILITY AND DISPOSAL). 5 Missed Dose If a planned dose of VENOFER is missed, it should be administered as soon as possible.
The schedule of administration should be adjusted to maintain the prescribed dosing interval. 5 OVERDOSAGE In case of drug overdose, seek emergency medical attention, even if there are no symptoms. Dosages of VENOFER in excess of iron needs may lead to the accumulation of iron in storage sites, resulting in hemosiderosis.
Periodic monitoring of iron parameters such as serum ferritin and PrVENOFER® Iron Sucrose Injection Page 7 of 31 transferrin saturation may assist in recognizing iron accumulation. VENOFER should not be administered to patients with iron overload and should be discontinued when serum ferritin levels exceed usual norms (see 7 WARNINGS AND PRECAUTIONS – General).
• The use of VENOFER® is contraindicated in patients with evidence of iron overload and patients with anemia not caused by iron deficiency. • VENOFER is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Iron in Canada.
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The schedule of administration should be adjusted to maintain the prescribed dosing interval.
It is unlikely that significant fetal iron overload would occur in iron deficient pregnant women receiving therapeutic doses of VENOFER to correct iron deficiency (see 7 WARNINGS AND PRECAUTIONS – General). Fetal bradycardia may occur following administration of parenteral irons.
It is usually transient and a consequence of a hypersensitivity reaction in the mother. Patients should be advised of the potential risk to the fetus. If intravenous administration of parenteral irons to pregnant women is considered, the unborn baby should be carefully monitored.
2 Breast-feeding VENOFER is excreted in the milk of rats. It is not known whether VENOFER is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VENOFER is administered to nursing women.
3 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. In a country where VENOFER is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five expired during or following a period when they received VENOFER, several other medications and erythropoietin.
Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to VENOFER or any other drugs could be established. 4 Geriatrics (> 65 years of age) Clinical studies with VENOFER have not identified differences in unintended responses between elderly and younger patients.
Nevertheless, dose selection for an elderly patient should be cautious, usually starting with lower doses, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
1 Adverse Reaction Overview The most common treatment-related adverse events were dysgeusia, hypotension [not otherwise specified (NOS)], nausea, and dizziness. In the HDD-CKD clinical indication group, the most common treatment-related adverse event was hypotension NOS.
In the NDD-CKD clinical indication group, the most common treatment-related adverse event was dysgeusia in the VENOFER® group. In the PDD-CKD clinical indication group, the most common event in the VENOFER group was diarrhea. The most common treatment-emergent adverse events related to study drug were hypotension NOS in the 100 mg dose group, dysgeusia in the 200 mg dose group, diarrhea NOS in the 300 mg and 400 mg dose groups, and peripheral edema, dizziness, and hypotension NOS in the 500 mg dose group.
No dose-related trends were noted for serious adverse events or premature discontinuations due to PrVENOFER® Iron Sucrose Injection Page 10 of 31 adverse events. No clinically important incidence of hypersensitivity/allergic reaction was observed in the clinical studies.
Hypotension has been reported frequently in hemodialysis patients receiving IV iron.
Hypersensitivity Reactions:
See 7 WARNINGS AND PRECAUTIONS. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Serious episodes of hypotension occurred in 2 patients treated with VENOFER at a dose of 500 mg.
S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had other prior intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with VENOFER there were no occurrences of adverse events that precluded further use of VENOFER.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse Events observed […]
Particular caution should be exercised to avoid iron overload where anemia unresponsive to treatment has been incorrectly diagnosed as iron deficiency anemia. Symptoms associated with overdosage or infusing VENOFER too rapidly include hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse.
Most symptoms have been successfully treated with IV fluids, corticosteroids and/or antihistamines. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, Composition and Packaging VENOFER® is a brown, viscous, sterile, nonpyrogenic, aqueous solution containing 20 mg elemental iron per mL in the form of an iron (III)-hydroxide sucrose complex as the active ingredient, and water for injection.
1. The sterile solution has an osmolarity of 1250 mOsmol/L. The product does not contain preservatives or dextran polysaccharides. VENOFER is available in 5 mL single dose vials, sold in boxes of 10. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Because body iron excretion is limited and excess tissue iron can be hazardous, caution should be exercised in the administration of parenteral iron formulations, and treatment should be withheld when there is evidence of tissue iron overload.
Patients receiving VENOFER require periodic monitoring of hematologic parameters, including hemoglobin, hematocrit, serum ferritin and transferrin saturation. Generally accepted guidelines recommend withholding administration of intravenous iron formulations from patients demonstrating a transferrin saturation > 50% and or serum ferritin > 800 ng/mL (see 4 DOSAGE AND ADMINISTRATION and 5 OVERDOSAGE).
Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus, serum iron values may be reliably obtained 48 hours after IV dosing. Local Reactions Care must be taken to avoid paravenous infiltration. If this occurs, the infusion of VENOFER should be discontinued immediately.
Ice may be applied to cause local vasoconstriction and decrease fluid Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous […]