If the first infusion is tolerated, administer subsequent infusions. Apr 01, 1978 2 full prescribing information 1 indications and usage mmr ii is a vaccine indicated for active immunization for the prevention of measles, mumps, and. Venofer iron sucrose fda labels, warnings, reactions fda. Feraheme package insert, amag pharmaceuticals, lexington, mass, usa, 2015.
The safety and effectiveness of venofer in pediatric patients has not been established. This will allow quick identification of new safety information. For your adult patients with iron deficiency anemia ida, injectafer is the only fdaapproved intravenous iv iron that provides up to 1500 mg of iron in 2 administrations, separated by at least 7 days. For adult patients weighing less than 50 kg 110 lb, give each dose as 15 mgkg body weight for a total cumulative dose not to exceed 1500 mg of iron per course of. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. These highlights do not include all the information needed to use vimpat safely and effectively.
Usually 300 mg in 250ml ns by iv infusion over 2 h. It was designed to gradually release iron once inside the body, which may decrease the potential for some side effects and conveniently give you more iron in just 2 administrations. Published studies on intravenous iron sucrose treatment after first trimester of pregnancy not shown adverse maternal or fetal outcomes. Venofer iron sucrose injection, usp rx only description venofer iron sucrose injection, usp is a brown, sterile, aqueous, complex of polynuclear iron iiihydroxide in sucrose for intravenous use. Venofer is indicated for the treatment of iron deficiency anemia ida in patients with chronic. Highlights of prescribing information vaginal atrophy. Venofer iron sucrose injection, usp, an iron replacement product, is an aqueous. Information for the user venofer 20 mg iron ml solution for injection or concentrate for solution for infusion iron sucrose this medicine is subject to additional monitoring. The usual total treatment course of venofer is mg. Intravenous iron therapy venofer or feraheme or iron dextran.
Parenteral iron safety and the special article just the faqs. Iron sucrose injection has a molecular weight of approximately 34,000 60,000 daltons and a proposed structural formula. Venofer has not been studied in patients younger than 2 years of age. Gamunexc is a sterile solution for injection supplied in 1 g 10 ml, 2. It is important to understand the etiology of the reduced number of circulating red blood cells to treat the anemia appropriately. Trade names infed sanofi aventis venofer american regent inc ferrlecit sanofi aventis us feraheme amag pharmaceuticals injectafer american regent inc fda approved indication iron deficiency in patients whom oral administration is unsatisfactory or impossible. Highlights of prescribing information qt prolongation has. Parenteral iron safety and the special article just the. Blood transfusion reduction with intravenous iron in gynecologic cancer patients receiving chemotherapy.
Physicians have trusted venofer to treat 20 million patientsand counting. Adult patients with nondialysis dependentchronic kidney disease nddckd administer venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 ml of 0. Venofer injection fda prescribing information, side effects. Monoferrictm product monograph page 1 of 37 product monograph including patient medication information prmonoferrictm iron isomaltoside for injection 100 mg elemental ironml as iron isomaltoside. See important safety information and prescribing information. Venofer may cause clinically significant hypotension. General information about the safe and effective use of orencia. Only administer venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Venofer iron sucrose injection, usp is indicated in the treatment of iron deficiency. Chronic anemia and the role of the infusion therapy nurse.
Venofer iron sucrose 20 mg iron ml, solution for injection or concentrate for solution for infusion summary of product characteristics smpc by vifor pharma. Benzyl alcohol is an irritant and may cause hypersensitivity reactions, including local irritation and skin reactions. Product monograph ferrlecit sodium ferric gluconate complex. Venofer injection fda prescribing information, side. Page 5 of 27 hypotension also has been reported in nondialysisdependent nddck and peritoneal dialysis. Upliznatm inebilizumabcdon injection, for intravenous use. Refer to package insert for additional information.
Iron sucrose venofer injection is an iron replacement product. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs and monkeys at doses of 50 mg. Venofer should only be administered where the indication is confirmed by appropriate investigations e. Various studies involving intravenously administered 59fe iron dextran to iron deficient subjects, some of whom had coexisting diseases, have yielded halflife values ranging from 5 hours to more than 20 hours. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. Jan 02, 2019 trade names infed sanofi aventis venofer american regent inc ferrlecit sanofi aventis us feraheme amag pharmaceuticals injectafer american regent inc fda approved indication iron deficiency in patients whom oral administration is unsatisfactory or impossible. Highlights of prescribing information these highlights do not. You can help by reporting any side effects you may get. For additional safety information, please see full prescribing information. Dilute injectafer in up to 250 ml but not more of sterile 0. Brief patient counseling information can be found in the iron sucrose venofer package insert. Hypotension has been reported frequently in hemodialysis dependent chronic kidney disease patients receiving intravenous iron.
Venofer iron sucrose injection, usp is an established and effective treatment for chronic kidney disease ckd patients experiencing iron deficiency anemia ida. If you have an infection when taking orencia, you may have a higher. The dosing for iron replacement treatment in pediatric patients with peritonealdialysisdependent ckd, hemodialysisdependent ckd, or nondialysisdependent ckd has not been established. A wealth of experience in treating iron deficiency. Sep 01, 2020 the usual total treatment course of venofer is mg.
The summary of product characteristics for venofer describes. Injectafer treatment may be repeated if iron deficiency anemia reoccurs. Chronic anemia develops over a course of weeks to months and is usually mild to moderate in nature. The dosage of venofer is expressed in mg of elemental iron.
This leaflet is part iii of a threepart product monograph. Sep 03, 2017 do not mix venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Dose modifications for vectibix concerning dermatologic toxicity are provided see dosage and administration 2. Solution for injection or concentrate for solution for infusion.
The recent special article on iron therapy in dialysis by van wyck, bailie, and aronoff1 contains statements comparing the relative safety of the iron dextran, ferric gluconate, and iron sucrose. Venofer can be given as a maximum of 200mg not more than 3 times per week. Protocol for the use of intravenous iron sucrose venofer. Venofer iron sucrose 20 mg iron ml, solution for injection or. Iron deficiency anemia in adult and pediatric patients with. The prevention of nausea andor vomiting associated with initial and repeat courses of emetogenic cancer. Product monograph ferrlecit sodium ferric gluconate. Fda approved for the treatment of iron deficiency anemia in patients with chronic kidney disease ckd. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion.
Venofer treatment may be repeated if iron deficiency reoccurs. Indication of any immediate medical attention and special treatment needed if you feel unwell, seek medical advice show the label where possible. Injectafer is an iron replacement product indicated for the treatment of iron deficiency. The dosing for iron replacement treatment in pediatric patients with peritonealdialysisdependent ckd, hemodialysis. The active ingredient in famotidine injection is a histamine h 2receptor antagonist. Injectafer is a dextranfree iron replacement product that is administered directly into the vein. Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose.
Eribulin mesylate is a synthetic analogue of halichondrin b, a product isolated from the marine sponge halichondria okadai. Learn about feraheme ferumoxytol injection, an effective iv iron treatment for eligible iron deficiency anemia ida patients. Safely throw away medicine that is out of date or no longer needed. Venofer provides iv iron therapy for the treatment of ida in adult and pediatric patients.
In the presence of such factors and particularly in the presence. Mgpcipi medication guidepatient counseling informationpackage insert. Venofer provides iv iron therapy for the treatment of ida in adult and pediatric patients 2 years and older with ckd. Intravenous iron therapy in patients with iron deficiency. Full prescribing information 1 indications and usage zofran is indicated for the prevention of nausea and vomiting associated with. Venofer guidelines for use 2011 university health system.
Keep orencia and all medicines out of the reach of children. Parenteral iron therapy is associated with a characteristic pattern. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment see important safety information. Venofer iron sucrose injection, for intravenous use. They compare a retrospective study of iron dextran reactions to a combination of prospective trials of ferric gluconate to the iron sucrose reactions from a spontaneous reporting system. Total cumulative venofer dose number of 100mg ampoules for hb increase. Keep orencia in the original package and out of the light. Highlights of prescribing information ii these highlights do. Venofer must only be administered intravenously either by slow injection or by infusion.
Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. 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. Highlights of prescribing information these highlights do not include all the information needed to use zofran tablets, zofran odt, and zofran oral solution. Fax prescription for 1 dose of iron sucrose venofer 200mg x 1 to patients community.
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