Injectafer (ferric carboxymaltose) drug profile, 2024?

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Injectafer® (Ferric Carboxymaltose)
Drug profile – 2024 update

Feature	Detail
Brand & Trade Names	Injectafer® (United States & Canada) – also sold as Ferinject® in the European Union, Canada, Japan, and many other markets.
Active Ingredient	Ferric carboxymaltose (iron (III) carboxymaltose) 1 g (100 mg/mL).
Class	Intravenous iron replacement therapy.

1. Indications

Condition	Recommended Use
Iron‑deficiency anemia (IDA) – in adults, pediatric patients (≥ 3 months), and infants (≥ 6 months) when oral iron therapy is ineffective, contraindicated, or not tolerated.	One 1‑g infusion per 15 min; repeat up to 6 infusions per month (maximum 6 g per month).
Chronic kidney disease (CKD) – both dialysis‑dependent and non‑dialysis patients who require iron supplementation.	1 g per 15 min; repeat per ESA protocol (usually 1–2 g per month).
Inflammatory bowel disease (IBD) – Crohn’s disease or ulcerative colitis with IDA.	Same dosing schedule as above.
Other chronic diseases – cancer, HIV/AIDS, and other chronic inflammatory states associated with IDA when oral iron is inadequate.	Same dosing schedule.

Key point: Injectafer delivers 1 g of elemental iron in a single infusion, a major advantage over older preparations that required multiple 200 mg doses.

2. Dosage & Administration

Population	Dose	Administration Time	Frequency	Notes
Adults & Adolescents (≥ 13 yrs)	1 g (100 mg/mL)	15 min infusion	Up to 6 times/month	Pre‑infusion: assess baseline hemoglobin, ferritin, transferrin saturation.
Children (3 months–12 yrs)	0.5–1 g (based on weight)	15 min infusion	Up to 6 times/month	Weight‑based dosing: 20 mg iron/kg (max 1 g).
Infants (≤ 3 months)	0.5 g (50 mg/mL)	15 min infusion	1–2 times/month	Follow pediatric label.
Pregnant/Lactating Women	1 g	15 min infusion	Up to 6 times/month	Use only if benefits outweigh risks; monitor fetal growth.
Patients with CKD	1 g	15 min infusion	As per ESA schedule	Consider ESA (erythropoiesis‑stimulating agent) combination.

Premedication – Not routinely required. Use antihistamine, acetaminophen, or corticosteroid only if a history of hypersensitivity reactions.

Infusion Rate – 100 mg/mL (10 mL) over 1 min, then 90 mL over 14 min. Total 15 min.

3. Pharmacology

Property	Detail
Mechanism of Action	Ferric carboxymaltose is a highly stable iron‑polysaccharide complex. The carboxymaltose matrix protects iron from premature release, enabling slow, sustained delivery to the reticuloendothelial system. Iron is released intracellularly and incorporated into ferritin or transferrin.
Absorption & Distribution	Administered IV – 100 % bioavailability. Iron is primarily stored in the liver, spleen, and bone marrow.
Metabolism	Degraded in the reticuloendothelial system; iron is released to the circulation.
Elimination	Iron is eliminated via the reticuloendothelial system and excreted in feces; no renal clearance of the complex.
Half‑life	Not applicable for the complex; elemental iron has a half‑life of ~14 days when stored.

4. Contraindications & Precautions

Contraindication	Rationale
Known hypersensitivity to ferric carboxymaltose, polysaccharide components, or any excipients.	Risk of anaphylaxis or severe allergic reaction.
Severe iron overload (hemochromatosis, transfusional iron overload).	Excessive iron can be toxic.
Active infection where iron could fuel bacterial growth.	Not absolute but warrants caution.
Pregnancy & lactation – Use only if benefits outweigh risks.	Limited safety data; not contraindicated but cautious use advised.
Patients with severe renal impairment on dialysis – not a contraindication per se but dosing adjustments required.	Monitor serum creatinine and ESA response.

Precautions

Hypophosphatemia – Especially with repeated infusions (> 2 g/month) in CKD patients. Monitor serum phosphate after each infusion if clinically indicated.
Hypersensitivity – Although rare, anaphylactic reactions have been reported. Be prepared to manage with epinephrine, antihistamines, and steroids.
Hyperglycemia – A transient rise in blood glucose can occur; monitor glucose in patients with diabetes.
Drug interactions – No major interactions with oral or IV drugs; avoid concurrent use of iron chelators that may sequester iron.

5. Adverse Reactions (Clinical Trials & Post‑marketing)

Common	Incidence	Typical Dose/Infusion
Headache	1–2 %	1 g infusion
Injection‑site pain, erythema	1–2 %	1 g infusion
Nausea, dizziness	< 1 %	1 g infusion

Serious	Incidence	Typical Dose/Infusion
Hypersensitivity (anaphylaxis)	< 0.1 %	1 g infusion
Hypophosphatemia (serious)	< 1 % (more common in CKD)	> 2 g/month
Hyperglycemia requiring insulin	< 1 %	1 g infusion
Transient tachycardia	< 1 %	1 g infusion

Clinical note: The rate of serious hypersensitivity reactions is very low (< 0.1 %). Most mild reactions resolve with supportive care.

6. Drug Interactions

Antacids, H₂ blockers, PPIs – No clinically significant interaction; the IV route bypasses GI absorption.
Iron chelators (e.g., deferoxamine) – Should not be used concurrently because they can

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Injectafer (ferric carboxymaltose) drug profile, 2024?

1. Indications

2. Dosage & Administration

3. Pharmacology

4. Contraindications & Precautions

5. Adverse Reactions (Clinical Trials & Post‑marketing)

6. Drug Interactions