Anefer100 mg/5 ml

Anefer is a parenteral (intravenous) iron replacement product used to treat iron-deficiency anemia in patients for whom oral iron is inadequate, not tolerated, or clinically inappropriate.

Established / Guideline-Supported Uses

• Iron-deficiency anemia in chronic kidney disease (CKD): The primary, well-established indication is treatment of iron-deficiency anemia in adult and pediatric patients (2 years and older) with chronic kidney disease, including patients on hemodialysis, peritoneal dialysis, and those who are not yet dialysis-dependent.

Other Guideline-Supported / Adjunct Uses

• Iron-deficiency anemia associated with inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) when oral iron is not tolerated or ineffective.
• Correction of iron deficiency in patients with intolerance, malabsorption, or non-compliance with oral iron therapy.
• As an adjunct to erythropoiesis-stimulating agents (ESAs) in CKD-related anemia, where iron replacement supports an adequate response to ESA therapy.
• Selected pre-operative, post-partum, or heavy uterine bleeding-associated iron-deficiency states where rapid iron repletion is clinically indicated, per local (Bangladesh) prescribing practice.

Anefer is not indicated for anemias not caused by iron deficiency (e.g. hemolytic anemia, anemia of chronic disease without proven iron deficiency).

Each mL of Iron Sucrose Injection [Elemental Iron] contains iron in the form of iron sucrose complex equivalent to 20 mg of elemental iron (commonly supplied as ampoules/vials providing 100 mg elemental iron per 5 mL). The exact strength and pack size should be confirmed on the product label.

Anefer is a sterile, brown, colloidal solution of polynuclear iron (III)-hydroxide in complex with sucrose, given by slow intravenous injection or infusion. It is used to replenish iron stores and correct iron-deficiency anemia when oral iron therapy is insufficient, poorly tolerated, or clinically unsuitable, most commonly in patients with chronic kidney disease.

As a parenteral iron product, Anefer is a prescription-only medicine that must be administered by a qualified healthcare professional in a clinical setting equipped to monitor for and manage hypersensitivity reactions.

Hematinic agent — parenteral (intravenous) iron replacement therapy. Anefer belongs to the iron-carbohydrate complex class of injectable iron preparations.

Iron Sucrose Injection [Elemental Iron] supplies iron in a form that closely resembles physiological ferritin, allowing it to be released to iron-binding and iron-transport proteins in the body. Following intravenous administration, the iron-sucrose complex is taken up predominantly by the reticuloendothelial system (liver, spleen, bone marrow), where iron is cleaved from the sucrose carrier.

The released iron is either stored as ferritin or transported by transferrin to erythroid precursor cells in the bone marrow, where it is incorporated into hemoglobin, correcting iron-deficiency anemia and replenishing depleted iron stores. The sucrose component is eliminated primarily via the kidneys.

Anefer must be administered only by a healthcare professional in a facility equipped with resuscitation equipment and trained staff, because of the risk of serious hypersensitivity reactions.

• Administer by slow intravenous injection (undiluted) at a rate not exceeding the labeled recommendation, or as an intravenous infusion after dilution in sterile 0.9% sodium chloride solution.
• Do not administer by intramuscular injection.
• Observe the patient for signs of hypersensitivity during administration and for at least 30 minutes after each dose, with resuscitation facilities (including oxygen, epinephrine, and airway support) immediately available.
• Do not mix with other medications or add to parenteral nutrition solutions for direct injection.
• Each vial/ampoule is intended for single use; discard any unused portion.

Oral iron preparations: Anefer may reduce the absorption of concomitantly administered oral iron supplements. Oral iron therapy should generally not be started until at least several days after the last dose of Anefer, or as directed by the prescribing physician.

Other parenteral iron products: Concurrent use with other IV iron formulations is not recommended due to the risk of cumulative iron overload.

No other well-established, clinically significant drug-drug interactions have been identified for Anefer. Inform the physician of all other medicines being used, including erythropoiesis-stimulating agents, which are often co-prescribed rather than interacting adversely.

Adverse effects associated with Anefer range from common, mild infusion-related symptoms to rare but serious hypersensitivity reactions.

Common

• Hypotension (transient, during or shortly after administration)
• Nausea, vomiting, diarrhea
• Headache, dizziness
• Muscle or leg cramps
• Injection-site reactions (pain, discoloration, swelling)
• Altered/metallic taste

Serious (Uncommon to Rare)

• Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions with hypotension, bronchospasm, loss of consciousness, or collapse — see Precautions and Warnings.
• Significant hypotension requiring monitoring/intervention.
• Arthralgia, myalgia, chest pain (uncommon).

Patients should seek immediate medical attention for symptoms such as difficulty breathing, swelling of the face/throat, rash, or fainting.

Pregnancy: Data on the use of Anefer during pregnancy, particularly in the first trimester, are limited. Anefer should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and generally only after the first trimester when treatment of iron-deficiency anemia is clearly needed and oral iron is inadequate or not tolerated. Use should be under direct physician supervision.

Lactation: Small amounts of iron from Anefer may pass into breast milk; available data have not shown adverse effects in breastfed infants, but a nursing mother should use Anefer only on the advice of her physician, who will weigh the clinical need for maternal iron therapy against any potential infant exposure.

Hypersensitivity Reactions

Anefer can cause serious, potentially life-threatening hypersensitivity reactions, including anaphylaxis. It must only be administered in settings where personnel and resuscitation equipment (including oxygen and epinephrine) are immediately available. Patients should be monitored closely during each administration and for at least 30 minutes afterward for signs and symptoms of a reaction (e.g. rash, itching, wheezing, hypotension, dizziness).

Hypotension

Rapid administration may cause hypotension. Administer slowly, at the recommended rate, and monitor vital signs.

Iron Overload

Excessive or inappropriate use of Anefer can lead to iron overload, with accumulation in the liver and other organs. Dosing must be based on the individually calculated total iron deficit; periodic monitoring of iron parameters (e.g. serum ferritin, transferrin saturation) is recommended, particularly with repeated courses.

Active Infection

Iron may theoretically worsen certain bacterial or fungal infections by supporting pathogen growth. Use Anefer with caution in patients with active systemic infection; treatment should generally be deferred until the infection resolves unless the clinical need for iron repletion is urgent, as judged by the treating physician.

Not for Self-Administration

Anefer is a prescription-only, hospital/clinic-administered intravenous therapy. It is not intended for home or self-administration by patients.

Excessive dosing or infusion rate of Anefer may cause acute toxicity, including hypotension, and can lead to iron overload with accumulation in the liver, heart, and other organs (hemosiderosis) if administered in doses exceeding what is required to correct the iron deficit.

There is no specific antidote routinely used at the bedside; management is supportive. If overdosage or a severe reaction is suspected, seek immediate medical attention or contact emergency services / a poison control center right away. Iron chelation therapy may be considered by treating physicians in cases of significant iron overload, based on clinical and laboratory assessment.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze. Each vial/ampoule is for single use only; discard any unused portion. Keep out of reach of children.

Renal impairment: Anefer is specifically indicated for iron-deficiency anemia associated with chronic kidney disease, including hemodialysis- and peritoneal dialysis-dependent patients; dosing is stratified by dialysis status (see Dosage and Administration).

Hepatic impairment: Use with caution; monitor closely for iron overload, as data on dosing adjustment in significant hepatic disease are limited.

Elderly: No overall differences in safety or efficacy have been established compared with younger adults; dose selection should still consider the individually calculated iron deficit and any comorbid renal/hepatic disease.

Active infection: Use with caution — see Precautions and Warnings.

Pediatric and pregnant/lactating patients: See Pediatric Uses and Pregnancy and Lactation sections.

Duration of treatment with Anefer is individualized and based on the total calculated iron deficit, the indication being treated, and the patient's hemoglobin and iron-parameter response. Courses are typically given as a defined series of doses over one to several weeks (e.g. up to 14 days for non-dialysis CKD, or a 28-day course for peritoneal dialysis patients); a hemodialysis patient may receive maintenance doses over an extended period as clinically required. The prescribing physician determines when the calculated iron deficit has been corrected and further doses are no longer needed.

Parenteral (intravenous) iron replacement agents; hematinics; iron-carbohydrate (iron-sucrose) complexes.

Iron Sucrose Injection [Elemental Iron] is a complex of polynuclear iron (III)-hydroxide with sucrose that mimics the structure of natural ferritin. After intravenous administration, it is taken up by cells of the reticuloendothelial system, where iron is released from the sucrose carrier, bound to transferrin, and delivered to the bone marrow for incorporation into hemoglobin during erythropoiesis, or stored as ferritin in tissue iron stores.

Anefer is approved for use in children 2 years of age and older for iron-deficiency anemia associated with chronic kidney disease, at a dose of 0.5 mg/kg by slow IV injection or infusion, not to exceed 100 mg per dose, with dosing individualized to the calculated iron deficit.

Safety and efficacy of Anefer in children younger than 2 years of age have not been established. Use in this age group should only occur under specialist supervision when no suitable alternative exists and the potential benefit is judged to outweigh the risk.