Elinjec 10ml Iv Inj/Inf

Description

Elinjec 500mg/10mL IV Injection

Description:

Elinjec is an intravenous formulation of ferric carboxymaltose, a colloidal iron complex used for the rapid treatment of iron deficiency anemia in adults who cannot tolerate or have not responded adequately to oral iron supplements. It is particularly beneficial for patients with chronic kidney disease (non-dialysis dependent), postpartum women, those with heavy uterine bleeding, or individuals with anemia associated with inflammatory bowel disease or chemotherapy without concurrent erythropoiesis-stimulating agents.

Dosage and Administration:

• Dosage Calculation: The required dose is determined based on the patient’s body weight and hemoglobin levels.
• Administration Routes:
  • Intravenous Injection: Administered undiluted. The maximum single dose is 15 mg iron/kg body weight, not exceeding 1,000 mg iron.
  • Intravenous Infusion: Diluted in 0.9% sodium chloride solution. The maximum single dose is 20 mg iron/kg body weight, not exceeding 1,000 mg iron.
• Administration Rates:
  • Injection: For doses up to 200 mg, administer at a rate of 100 mg iron per minute. For doses between 200 mg and 500 mg, administer at a rate of 100 mg iron per minute. For doses between 500 mg and 1,000 mg, administer over 15 minutes.
  • Infusion: Dilute as per the recommended guidelines and administer at the prescribed rate.

Indications:

• Iron deficiency anemia in adults who cannot tolerate or have not responded to oral iron supplements.
• Chronic kidney disease (non-dialysis dependent).
• Postpartum women with iron deficiency anemia.
• Anemia associated with heavy uterine bleeding.
• Anemia related to inflammatory bowel disease.
• Chemotherapy-induced anemia without concurrent use of erythropoiesis-stimulating agents.

Contraindications:

• Hypersensitivity to ferric carboxymaltose or any component of the formulation.
• Anemia not attributed to iron deficiency (e.g., anemia of chronic disease).
• Evidence of iron overload or disturbances in iron utilization.

Warnings and Precautions:

• Hypersensitivity Reactions: Parenteral iron preparations can cause hypersensitivity reactions, including serious and potentially fatal anaphylactic/anaphylactoid reactions. Patients should be monitored for at least 30 minutes following each administration.
• Paravenous Leakage: Avoid extravasation during administration, as leakage can lead to skin irritation and long-lasting discoloration.
• Iron Overload: Use with caution in patients with conditions that predispose to iron overload.
• Liver Dysfunction: In patients with hepatic dysfunction, parenteral iron should only be administered after careful benefit/risk assessment.

Side Effects:

• Common: Nausea, dizziness, headache, hypertension, injection site reactions, hypophosphatemia.
• Uncommon: Anaphylaxis, arthralgia, back pain, chest pain, fatigue, flushing, hypotension, malaise, tachycardia, myalgia, paraesthesia, dysgeusia, peripheral edema, chills, pruritus, pyrexia, rigors, urticaria.
• Rare: Dyspnea, loss of consciousness, anxiety, phlebitis, syncope, flatulence, pallor.

Drug Interactions:

• Oral Iron: The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, oral iron therapy should not be started for at least 5 days after the last administration of ferric carboxymaltose.

Pregnancy and Lactation:

• Pregnancy: Limited data are available. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus.
• Lactation: Limited data suggest that ferric carboxymaltose is excreted in human milk in negligible amounts. The effect on the breastfed infant is unknown.

Storage:

• Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F).
• Protect from light; do not freeze.
• Keep out of reach of children.

Conclusion:

Elinjec 500mg/10mL IV Injection is an effective intravenous iron therapy for the treatment of iron deficiency anemia in adults who cannot tolerate or have not responded to oral iron supplements. It offers a rapid and efficient means of replenishing iron stores, improving hemoglobin levels, and alleviating symptoms associated with anemia. Healthcare providers should assess each patient’s individual needs and monitor for potential adverse reactions during and after administration.