Ferinject100 mg

Ferinject 100 mg is an intravenous (IV) iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in the following settings:

Established / Approved Uses

• Iron deficiency anemia in adult and pediatric patients (1 year of age and older) who have intolerance to oral iron or who have had an unsatisfactory response to oral iron.
• Iron deficiency anemia in adult patients with non-dialysis-dependent chronic kidney disease (CKD).

Guideline-Supported Use

• Iron deficiency in adult patients with chronic heart failure (New York Heart Association Class II/III) to improve exercise capacity, used as an adjunct alongside standard heart failure therapy rather than as monotherapy.

Ferinject 100 mg is not indicated for anemias not caused by iron deficiency and should not be used when iron deficiency has not been confirmed.

Ferinject 100 mg is a colloidal iron(III)-hydroxide carbohydrate complex formulated as a dark brown, sterile, aqueous solution for intravenous use. It is supplied in single-dose vials in strengths such as 500 mg iron/10 mL and 750 mg iron/15 mL (50 mg elemental iron per mL), depending on the manufacturer and market.

Ferinject 100 mg is a non-dextran, iron-carbohydrate complex designed for intravenous administration. Its carbohydrate shell allows controlled release of iron into the reticuloendothelial system, which permits administration of larger single doses of iron than many older parenteral iron products, reducing the number of infusions needed to replenish iron stores.

Ferinject 100 mg is used specifically for iron deficiency anemia when oral iron therapy is not tolerated, is ineffective, or when rapid iron repletion is clinically necessary. It is administered only by, or under the supervision of, a qualified healthcare professional in a setting equipped to monitor for and manage hypersensitivity reactions.

Ferinject 100 mg belongs to the therapeutic class of parenteral (intravenous) iron replacement agents, used in the management of iron deficiency anemia.

Ferinject 100 mg is a complex that makes iron available for incorporation into hemoglobin and iron storage proteins. Following intravenous administration, the carbohydrate shell is taken up by cells of the reticuloendothelial system (mainly in the liver, spleen, and bone marrow), where iron is released from the complex.

The released iron either binds to transferrin for transport to erythroid precursor cells for incorporation into hemoglobin, or is stored as ferritin, primarily in the liver. This mechanism allows Ferinject 100 mg to correct iron deficiency and support erythropoiesis (red blood cell production) more rapidly than oral iron in patients who cannot absorb or tolerate oral iron adequately.

Ferinject 100 mg must be administered only by a healthcare professional trained to manage anaphylaxis, in a setting with resuscitation equipment and trained staff immediately available, because of the risk of serious hypersensitivity reactions.

• May be given by slow intravenous injection (push) undiluted, at a rate of approximately 100 mg/minute for doses up to 750 mg (or per approved rate for higher single doses).
• May alternatively be given by intravenous infusion after dilution in a maximum of 250 mL of sterile 0.9% sodium chloride solution, infused over at least 15 minutes.
• Do not administer by any route other than intravenous.
• Monitor the patient for signs and symptoms of hypersensitivity during and for at least 30 minutes after each administration.
• Avoid extravasation, as leakage into surrounding tissue can cause long-lasting brown discoloration of the skin at the injection site.

Oral iron products: Concomitant administration of oral iron with Ferinject 100 mg may reduce the absorption of the oral iron. Oral iron therapy should generally not be restarted until at least several days after the last dose of Ferinject 100 mg, per clinical judgment.

Diagnostic imaging (MRI): Ferinject 100 mg can cause magnetic resonance imaging (MRI) artifacts by transiently altering the appearance of tissues, particularly the liver, spleen, kidney, and lymph nodes. If MRI is planned, clinicians should be informed of recent Ferinject 100 mg administration, as image distortion may persist for up to several months after dosing.

No clinically significant interactions with other medications have been well established for Ferinject 100 mg beyond those described above.

The most common side effects of Ferinject 100 mg include:

• Nausea
• Headache
• Dizziness
• Transient hypertension and flushing (see Precautions and Warnings for details)
• Injection site reactions (discoloration, pain, bruising)
• Hypophosphatemia (see Precautions and Warnings for full explanation)

Less common effects include altered taste (dysgeusia), tachycardia, hypotension, dyspnea, rash, and myalgia.

Rare but serious effects include hypersensitivity reactions up to and including anaphylaxis (see Contraindications and Precautions and Warnings), and, with repeated high cumulative dosing, symptomatic hypophosphatemic osteomalacia.

Pregnancy: Ferinject 100 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother, and generally should be avoided during the first trimester. Hypersensitivity reactions during infusion, if they occur, may have serious consequences for the fetus, including fetal bradycardia, particularly when reactions occur in the second or third trimester. Untreated iron deficiency anemia in pregnancy carries its own risks (e.g., preterm delivery, low birth weight), so the decision to treat should be individualized and made in consultation with a physician.

Lactation: Small amounts of iron from Ferinject 100 mg may pass into breast milk. Available data have not shown clear evidence of harm to breastfed infants, but a physician should weigh the benefits of breastfeeding against the mother's clinical need for Ferinject 100 mg and monitor the infant.

Hypersensitivity Reactions

Ferinject 100 mg can cause serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal. Ferinject 100 mg should only be administered in a setting where personnel and resuscitation equipment (including medications) are immediately available to manage anaphylaxis. Patients should be monitored for signs and symptoms of hypersensitivity during and for at least 30 minutes after each administration.

Hypophosphatemia

Ferinject 100 mg can cause symptomatic hypophosphatemia, which in some cases has led to osteomalacia and fractures requiring medical intervention, particularly with repeated dosing and prolonged treatment. Risk is higher in patients with malabsorption disorders, inflammatory bowel disease, vitamin D deficiency, hyperparathyroidism, or those on chronic medications affecting phosphate. Serum phosphate should be monitored, especially in patients requiring repeat courses, and levels should be assessed prior to repeat dosing within a 3-month period.

Hypertension

Transient elevations in blood pressure, sometimes with facial flushing, dizziness, or nausea, can occur following administration of Ferinject 100 mg. These typically resolve within 30 minutes. Blood pressure should be monitored following each administration.

Iron Overload

Ferinject 100 mg should not be given to patients with evidence of iron overload (see Contraindications). Excessive cumulative dosing beyond what is needed to correct iron deficiency and replenish iron stores can lead to accumulation of iron in tissues (hemosiderosis).

Laboratory Interference

Ferinject 100 mg may interfere with certain laboratory tests (e.g., serum iron and transferrin-based assays) for a period after administration, and can also affect MRI imaging (see Interactions).

Administration of Ferinject 100 mg in excess of the amount needed to correct iron deficiency and replenish iron stores may lead to accumulation of iron in storage sites, potentially resulting in iron overload (hemosiderosis) and, with repeated excessive dosing, hypophosphatemic osteomalacia. There is no specific antidote for Ferinject 100 mg overdosage.

If overdosage or a serious adverse reaction is suspected, seek immediate medical attention or contact emergency services/a poison control center. Management is supportive and should be directed by a physician based on the patient's clinical status; this may include monitoring of iron indices, phosphate, and symptomatic treatment as clinically indicated.

Store at room temperature (20°C to 25°C; brief excursions between 15°C and 30°C are permitted), away from light. Do not freeze. Keep out of reach of children. Discard any unused portion of a single-dose vial.

Renal Impairment

Ferinject 100 mg is indicated for iron deficiency anemia in adults with non-dialysis-dependent chronic kidney disease, and no dose adjustment is required based on renal function; however, patients with renal impairment should be monitored appropriately.

Hepatic Impairment

Ferinject 100 mg has not been well studied in patients with hepatic impairment. Use with caution and avoid in patients with significant hepatic dysfunction where iron accumulation could worsen liver injury, unless benefit clearly outweighs risk.

Elderly

No overall differences in safety or effectiveness have been observed between elderly and younger patients, though greater sensitivity in some older individuals cannot be ruled out; use with routine monitoring.

Pediatric Patients

See Pediatric Uses section.

A standard course of Ferinject 100 mg typically consists of two doses given at least 7 days apart (or a single higher dose, depending on product and indication), rather than continuous or open-ended therapy. Ferinject 100 mg is not intended for long-term maintenance iron supplementation outside of the specific repeat-dosing schedules described in the approved labeling (e.g., heart failure maintenance dosing).

Hemoglobin response should be reassessed no sooner than 4 weeks after completing a course. A repeat course may be considered only if iron deficiency anemia recurs, and serum phosphate should be checked before any repeat course given within 3 months of a prior course.

Intravenous iron replacement agents; Hematinics / antianemic parenteral iron preparations.

Ferinject 100 mg works by delivering bioavailable iron directly into the bloodstream, bypassing the gastrointestinal absorption step required by oral iron. The iron-carbohydrate complex is engineered to release iron in a controlled manner, minimizing free (unbound) iron and reducing the risk of iron-related oxidative toxicity while still allowing rapid replenishment of body iron stores.

The safety and effectiveness of Ferinject 100 mg for the treatment of iron deficiency anemia in patients who have intolerance to oral iron or an unsatisfactory response to oral iron have been established in pediatric patients 1 year of age and older. Dosing in this population is weight-based (see Dosage).

The safety and effectiveness of Ferinject 100 mg have not been established in children younger than 1 year of age, and have not been established for the heart failure indication in pediatric patients. Ferinject 100 mg should not be used in these populations outside of the studied and approved settings.