Ferisen

Approved Indications:

• Iron Deficiency Anemia (IDA) in adults and children ≥14 years when:
• Oral iron preparations are ineffective or cannot be used
• There is a clinical need for rapid iron supply
• Iron Deficiency in Chronic Kidney Disease (CKD)
• Non-dialysis-dependent CKD: when oral iron is unsuitable or ineffective
• Dialysis-dependent CKD: as part of total iron therapy
• Iron Deficiency associated with Chronic Inflammatory Conditions such as:
• Inflammatory Bowel Disease (IBD)
• Congestive Heart Failure (CHF)
• Cancer-related anemia (especially in patients receiving erythropoiesis-stimulating agents)
• Postpartum Iron Deficiency
• Pre-operative Iron Deficiency Anemia in patients undergoing elective surgery to reduce transfusion requirements

Important Off-label Uses:

• Iron deficiency in bariatric surgery patients
• Iron-deficiency anemia in heart failure with preserved ejection fraction (HFpEF)

General Principles:

• Ferric Carboxymaltose is administered intravenously (IV) only.
• Maximum single dose: 1,000 mg of elemental iron
• May be repeated based on total iron deficit and patient’s response.

Adult Dosage:

• <50 kg: 15 mg/kg per infusion (maximum 500 mg/week)
• ≥50 kg: 15 mg/kg per infusion (maximum 1,000 mg/week)
• Total cumulative dose based on Ganzoni’s formula or clinical estimation of iron deficit.

Pediatric Use:

• Approved in adolescents ≥14 years.
• Same dose calculation based on weight and hemoglobin deficit.

Renal Impairment:

• No dose adjustment needed.
• Frequently used in CKD patients, including dialysis populations.

Hepatic Impairment:

• Use with caution in patients with elevated liver enzymes (ALT/AST >3x ULN)
• Avoid in severe hepatic dysfunction with iron overload.

Administration:

• IV push (undiluted) over 15 minutes OR
• Diluted infusion in 100–250 mL 0.9% sodium chloride over 15–30 minutes
• Monitor for hypersensitivity reactions during and 30 minutes post-infusion.

Ferric Carboxymaltose is a stable iron-carbohydrate complex. After IV administration, it is taken up by the reticuloendothelial system, primarily in the liver, spleen, and bone marrow. The complex is gradually broken down, releasing bioavailable iron that binds to transferrin and is subsequently utilized for hemoglobin synthesis in erythroid precursor cells. Its stability allows high doses to be administered without excessive free iron release, minimizing oxidative stress and toxicity.

• Absorption: Not applicable (IV route)
• Distribution:
• Rapid uptake by the reticuloendothelial system
• Distributed primarily to liver, spleen, and bone marrow
• Metabolism:
• Slowly metabolized within macrophages
• Iron incorporated into ferritin or transferrin-bound pools
• Elimination:
• Elemental iron is reutilized in erythropoiesis
• Carbohydrate moiety eliminated renally
• Half-life: ~7–12 hours (distribution phase)
• Bioavailability: 100% (IV use)
• Onset of effect: Increase in hemoglobin typically seen within 1–2 weeks

• Pregnancy:
• FDA Pregnancy Category: Not assigned (formerly Category C)
• Use only if clearly needed; no controlled studies in pregnant women
• Animal studies have shown no teratogenicity but some fetal toxicity at high doses
• Lactation:
• Very limited human data available
• Likely low risk due to minimal excretion into breast milk
• Caution advised, especially in neonates or preterm infants

• Primary Class: Parenteral Iron Preparation
• Subclass: Ferric iron complex – carbohydrate-based
• Generation: New-generation IV iron (non-dextran based)

• Known hypersensitivity to Ferric Carboxymaltose or any component
• Evidence of iron overload (e.g., hemochromatosis, hemosiderosis)
• Anemia not caused by iron deficiency
• First trimester of pregnancy (unless absolutely necessary)
• Active systemic infections (may exacerbate infection due to increased iron availability)

• Hypersensitivity Reactions: Rare but serious anaphylactic reactions may occur. Monitor patients closely during and post-infusion.
• Hypophosphatemia: May cause prolonged, symptomatic hypophosphatemia; monitor phosphate levels in high-risk individuals.
• Iron Overload: Avoid repeated administration without confirmed iron deficiency.
• Liver Dysfunction: Use caution in patients with hepatic impairment or elevated LFTs.
• Infection Risk: Iron may promote bacterial growth; defer use in acute infections.
• Blood Pressure Changes: Transient hypertension may occur during or immediately after infusion.
• Monitoring: Check hemoglobin, ferritin, transferrin saturation (TSAT), and phosphate levels periodically.

Common Adverse Effects (≥1%):

• Gastrointestinal: Nausea, constipation
• Musculoskeletal: Arthralgia, back pain, myalgia
• General: Headache, dizziness, fatigue
• Injection Site: Pain, discoloration, swelling

Serious Adverse Effects:

• Anaphylaxis or severe hypersensitivity
• Symptomatic hypophosphatemia (e.g., muscle weakness, confusion)
• Hypotension or hypertension during infusion

Rare Adverse Effects:

• Skin rash or itching
• Transient increases in liver enzymes
• Chest discomfort

Onset & Severity:

• Most adverse effects occur during or shortly after infusion
• Hypophosphatemia may develop after multiple doses and persist for weeks

• Oral Iron Supplements: Avoid concurrent use – may cause iron overload
• Phosphate Binders: May increase risk of hypophosphatemia
• ACE Inhibitors or ARBs: Increased risk of hypotension during infusion
• No significant CYP450 interactions: Ferric Carboxymaltose is not metabolized via hepatic enzymes

Food & Alcohol Interactions: Not applicable due to IV administration

• Hypophosphatemia Risk: Highlighted in recent guidelines and updated safety communications, especially in repeated high-dose use.
• Label Changes (EMA/FDA):
• Increased emphasis on monitoring phosphate in at-risk populations
• Guidance on avoiding use in first-trimester pregnancy
• Guidelines: KDIGO and European Society of Cardiology recommend IV iron (including Ferric Carboxymaltose) for iron deficiency in chronic kidney disease and heart failure when oral therapy is inadequate.

• Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Excursions allowed: 15°C to 30°C (59°F to 86°F)
• Protection: Do not freeze; protect from light
• Handling Precautions:
• Use immediately after opening vial
• Do not use if solution is cloudy or contains particles
• Shake gently if sedimentation occurs
• Dilution: If diluted, use within 12 hours at room temperature
• Packaging: Comes in single-use glass vials or pre-filled syringes