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FERRLECIT 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: FERRLECIT (sodium ferric gluconate complex in sucrose injection) is indicated for: • the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. 1.1 Pediatrics Pediatrics (˂ 18 years old): No data are available to Health Canada; therefore,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The dosage of FERRLECIT is expressed in terms of mg of elemental iron. 5 mg/mL). • Do not mix FERRLECIT with other medications, or add to parenteral nutrition solutions for intravenous infusion. 9% sodium chloride for injection has not been evaluated.
2 Recommended Dose and Dosage Adjustment The recommended dosage of FERRLECIT for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of FERRLECIT (125 mg of elemental iron). 0 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favourable hemoglobin or hematocrit response.
Patients may continue to require therapy with FERRLECIT at the lowest dose necessary to maintain the target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits. FERRLECIT has been administered at sequential dialysis sessions by infusion or by slow IV injection during the dialysis session itself.
1 Pediatrics). 9% sodium chloride for injection, administered by intravenous infusion over 1 hour. 5 mg/min). In case of intramuscular or paravenous injection, the administration of FERRLECIT should be stopped immediately. Should hypersensitivity reactions or signs of intolerance occur, stop FERRLECIT immediately.
Monitor patients for signs and symptoms of hypersensitivity during and after FERRLECIT administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer FERRLECIT when personnel and resuscitative interventions are immediately available for the treatment of serious hypersensitivity reactions.
). Monitor patients for signs and symptoms of hypotension following FERRLECIT administration.
Immune Hypersensitivity and Anaphylactic Reactions:
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life- threatening and fatal, have been reported in patients receiving FERRLECIT. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
Several cases of mild to moderate hypersensitivity reactions characterized by wheezing, dyspnea, hypotension, rash and/or pruritus were observed in pivotal and post-market studies. Although very rare, anaphylactic(oid) reactions have been reported in worldwide clinical safety studies and spontaneous post-marketing reports (see 8 ADVERSE REACTIONS).
Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to iron containing medicinal products for IV administration.
In patients with present coronary disease or risk factors for coronary disease, Kounis syndrome may be more severe. In those patients, iron containing medicinal products for intravenous administration, such as FERRLECIT, should be used only after careful risk/ benefit evaluation.
The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy. g. rheumatoid arthritis, systemic lupus erythematosus, Crohn’s disease).
Should hypersensitivity reactions or signs of intolerance occur, stop FERRLECIT immediately. Most reactions associated with intravenous iron preparation occur within 30 minutes of the completion of the infusion. Monitor patients for signs and symptoms of hypersensitivity during and after FERRLECIT administration for at least 30 minutes and until clinically stable following completion of the infusion.
1 Pregnant Women 12/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics.................................................................................................................. 2 Geriatrics ..................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 4 4 DOSAGE AND ADMINISTRATION................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................
5 5 OVERDOSAGE............................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations .................................................................................................. 1 Pregnant Women ...............................................................................................
, sideroblastic anemia, lead anemia). • known or suspected hypersensitivity 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.
• known serious hypersensitivity to other parenteral iron products. • severe inflammatory diseases of the liver. • severe inflammatory diseases of the kidneys. 3 Pediatrics).
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Only administer FERRLECIT when personnel and resuscitative interventions are immediately available for the treatment of serious hypersensitivity reactions. Neurologic There have been post-marketing reports of seizures in patients receiving FERRLECIT.
5 Post-Market Adverse Reactions).
Reproductive Health:
Female and Male Potential • Fertility Studies to assess the effect of FERRLECIT on fertility were not conducted. Skin FERRLECIT should be administered with caution to avoid accidental intramuscular or paravenous injection. In addition, accidental intramuscular or paravenous administration can lead to reddish-brown FERRLECIT (sodium ferric gluconate complex in sucrose injection) Page 8 of 38 discolouration of the skin.
In case of intramuscular or paravenous injection, the administration of FERRLECIT should be stopped immediately. 1 Pregnant Women There were no adequate and well-controlled trials of FERRLECIT in pregnant women. FERRLECIT should not be used during pregnancy unless the benefits outweigh the risks including those to the fetus.
Treatment with FERRLECIT should be confined to second and third trimester, only if the benefit is judged to outweigh the potential risk for both the mother and the fetus. FERRLECIT was not teratogenic in animal studies but has shown reproductive toxicity (see 16 NON- CLINICAL TOXICOLOGY).
The fetus should be monitored during IV infusion of FERRLECIT in pregnant women. Severe adverse drug reactions in the mother and the fetus, including fetal bradycardia resulting from maternal anaphylactic reaction, severe hypotension and/or shock (outside the context of anaphylactic reaction), have been reported in women treated with FERRLECIT during the second and third trimester.
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. 5 Post-Market Adverse Reactions).
3 Pediatrics). 2 Breast-feeding It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FERRLECIT is administered to a nursing woman. FERRLECIT should therefore be used during lactation only after a careful weighing up of the benefits and risks.
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. FERRLECIT contains benzyl alcohol. Benzyl alcohol has been associated with a “gasping syndrome” that can be fatal in preterm newborn infants of low birth weight.
The syndrome is characterized by neurologic deterioration, metabolic acidosis, a striking onset of gasping respiration, hematologic abnormalities, skin breakdown, hepatic and renal failure, bradycardia, hypotension and cardiovascular collapse.
FERRLECIT must not be used in preterm or term newborn infants (see 2 CONTRAINDICATIONS). 4 Geriatrics Clinical studies of FERRLECIT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience FERRLECIT (sodium ferric gluconate complex in sucrose injection) Page 9 of 38 has not identified differences in responses between the elderly and younger patients. In particular, 51/159 hemodialysis patients in North American clinical studies were […]
2 Breast-feeding .................................................................................................... 3 Pediatrics............................................................................................................
4 Geriatrics ............................................................................................................ 8 8 ADVERSE REACTIONS.................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions............................................................................. 13 FERRLECIT (sodium ferric gluconate complex in sucrose injection) Page 3 of 38 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interaction Overview..................................................................................... 4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions ..........................................................................................
6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions......................................................................... 14 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ....................................................................................... 3 Pharmacokinetics ............................................................................................. 14 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
15 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 15 PART II: SCIENTIFIC INFORMATION ..................................................................................... 16 13 PHARMACEUTICAL INFORMATION ..........................................................................
16 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ..............................................................................
16 15 MICROBIOLOGY ...................................................................................................... 24 16 NON-CLINICAL TOXICOLOGY ....................................................................................
24 PATIENT MEDICATION INFORMATION ................................................................................ 32 FERRLECIT (sodium ferric gluconate complex in sucrose injection) Page 4 of 38 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS FERRLECIT (sodium ferric gluconate complex in sucrose injection) is indicated for: • the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.
1 Pediatrics Pediatrics (˂ 18 years old): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
2 CONTRAINDICATIONS FERRLECIT is contraindicated […]