Ferivate Fcm Injection 10ml

Ferivate FCM Injection is an intravenous (IV) iron therapy designed to treat iron deficiency anemia (IDA) in patients where oral iron supplements are ineffective, not tolerated, or when a rapid iron replenishment is required. It contains ferric carboxymaltose, a colloidal complex of iron (III) hydroxide and carboxymaltose, a carbohydrate polymer. This formulation allows for controlled release of iron to the body’s transport and storage proteins (transferrin and ferritin), minimizing the release of free iron, which reduces the risk of toxicity. The solution is a dark brown, non-transparent, aqueous dispersion, typically administered by healthcare professionals in a clinical setting

Uses:

• Treatment of iron deficiency anemia in adults and children (≥1 year) who are intolerant to or have an unsatisfactory response to oral iron.
• Management of IDA in patients with non-dialysis-dependent chronic kidney disease (CKD).
• Improvement of exercise capacity in adults with heart failure and iron deficiency.
• Off-label uses may include postpartum anemia, inflammatory bowel disease, or chemotherapy-associated anemia.

Dosage and Administration:

• Dosage (expressed as elemental iron):
  • Patients ≥50 kg: Typically, 750 mg IV in two doses separated by at least 7 days (total cumulative dose: 1,500 mg per course). Alternatively, a single dose of 15 mg/kg (max 1,000 mg).
  • Patients <50 kg: 15 mg/kg IV in two doses separated by at least 7 days.
• • Heart failure: May be administered every 6 weeks for up to 5 doses, or 500 mg at 12, 24, and 36 weeks if serum ferritin <100 ng/mL or 100–300 ng/mL with transferrin saturation <20%.
  • Pediatric (≥1 year): 15 mg/kg IV in two doses separated by at least 7 days.
  • Treatment may be repeated if IDA recurs.
• Administration:
  • Administered by IV injection (slow push at 100 mg/min) or IV infusion (diluted in sterile 0.9% sodium chloride solution, minimum concentration 2 mg/mL, over ≥15 minutes).
  • Can be given undiluted directly into a vein or via a dialyzer in dialysis patients.
  • Not to be administered subcutaneously or intramuscularly.
  • Patients must be monitored for at least 30 minutes post-administration for hypersensitivity reactions.
• Must be given in a setting with staff trained to manage anaphylactic reactions and full resuscitation facilities available.
• Dosage Calculation:
• Iron deficit may be calculated using the Ganzoni formula:
  Cumulative iron deficit (mg) = body weight (kg) × (target Hb – actual Hb [g/dL]) × 2.4 + iron storage depot (500 mg for lactation/postpartum).
• Maximum single dose: 1,000 mg (20 mL) per week by infusion, or 15 mg iron/kg by injection.

• Storage:

• Store at 20–25°C (68–77°F); excursions permitted between 15–30°C (59–86°F).
• Do not freeze or refrigerate.
• Use immediately after dilution or opening; discard any unused portion.
• Inspect vials for sediment or damage before use; use only sediment-free, homogeneous solutions.

• Packaging:

• Supplied in a 10 mL Type I glass vial with a bromobutyl rubber stopper and aluminum cap.
• Pack sizes: Typically 1, 2, or 5 vials (not all sizes may be marketed).
• The vial label includes: “Ferivate FCM Injection,” “Ferric Carboxymaltose 50 mg/mL,” “For Intravenous Use Only,” and manufacturer details (Leeford Healthcare Ltd.)

• Side Effects:

• Common: Nausea, flushing, dizziness, hypertension, injection site reactions (pain, swelling, redness, bruising), hypophosphatemia (low phosphate levels), headache, dark-colored stools (normal and harmless).
• Serious: Hypersensitivity reactions (including anaphylaxis), persistent high blood pressure, bone pain, symptoms of low phosphate (muscle weakness, mental/mood changes), iron overload.

Precautions:

• Contraindications: Hypersensitivity to ferric carboxymaltose or other parenteral iron products, anemia not caused by iron deficiency (e.g., microcytic anemia), iron overload, or disturbances in iron utilization.
• Warnings:
  • Monitor for hypersensitivity during and 30 minutes after administration.
  • Check serum phosphate levels in patients requiring repeat courses within 3 months or those at risk for hypophosphatemia.
  • Avoid in patients with liver disease, systemic lupus erythematosus, rheumatoid arthritis, severe asthma, eczema, or infections unless benefits outweigh risks.
• Pregnancy and Breastfeeding: Limited data; use only if clearly needed (typically in 2nd/3rd trimester). Ferric carboxymaltose is excreted in breast milk; consult a doctor for risks and benefits.
• Drug Interactions: Oral iron preparations are less effective when taken with Ferivate FCM. Avoid alcohol, as it may worsen side effects.