Iron Sucrose Injection: A Comprehensive Overview

Overview

Iron sucrose injection is primarily used in patients suffering from iron deficiency anemia (a condition where blood lacks enough healthy red blood cells) in chronic kidney disease or CKD (a longstanding kidney disease that causes kidney failure). The drug contains mineral ions, such as Iron sucrose, that are essentially needed by the body to perform various functions, such as oxygen transport. The drug is not recommended for treating any other type of anemia not caused by iron deficiency.

The drug was approved by the United States Food and Drug Administration (USFDA) in July 2000 for use in iron deficiency anemia in CKD.

Drug Group

The drug belongs to the iron replacement product’s class of medications. It is an organic compound, also called an o-glycosyl compound.

Indications

Iron sucrose injection treats iron deficiency anemia in CKD or chronic kidney disease cases.

Dose Form, Route, and Strength:

• The drug is available in three dosage forms and strengths: 50 mg or milligram/2.5 mL (milliliter) or 100 mg/5 mL (20 mg/mL) in single-dose vials.

• Route: Injection or infusion (intravenous (IV) or into the vein).

For Patients

What Is Iron Deficiency Anemia?

Iron deficiency anemia is a type of anemia in which the blood does not have enough healthy red blood cells that carry oxygen to the various tissues of the body. Due to iron deficiency, red blood cells cannot function properly and, thus, lack oxygen-carrying capacity.

What Is Chronic Kidney Disease or CKD?

Chronic kidney disease is a longstanding medical condition that damages the kidneys, making them unable to filter blood properly. This leads to the accumulation of waste and excess fluid in the body and causes other health conditions, such as stroke (lack of blood supply to the brain) and heart disease.

What Is Iron Sucrose Injection Prescribed For?

The drug is mainly prescribed for treating iron deficiency anemia (a lack of healthy red blood cells in the blood) in people suffering from CKD or chronic kidney disease. CKD is a prolonged kidney disease that eventually causes renal or kidney failure due to the kidneys' inability to filter blood.

How Should One Use Iron Sucrose Injection?

The drug is available as a liquid or solution for intravenous (into the vein) administration by a trained medical professional (a nurse or a doctor) in the hospital or clinical setting. Iron sucrose injection is injected for two to five minutes or may also be administered combined with other fluid and slowly infused for around 15 minutes to four hours, depending on the drug dosage. The doctor determines the number of doses required by the patient and the duration of the drug dosage based on the patient’s condition and how well one responds to the condition. If the patient’s iron levels in the body get low after the treatment, they may be prescribed an Iron sucrose injection again.

The drug can cause severe adverse reactions in a patient while receiving the drug, and the outcome can be life-threatening as well. Thus, the doctor monitors the patient carefully for over 30 minutes after receiving each drug dose. Therefore, one must inform the doctor in case they experience any symptoms, such as hoarseness, difficulty breathing, shortness of breath, swelling of the tongue, face, neck, eyes, lips, difficulty swallowing, dizziness, fainting, lightheadedness, stomach pain, muscle pain, hives, rash itching, slow, rapid, or weak heart rate, seizures, or loss of consciousness, swelling in hands, feet, or legs. In such cases, the doctor usually stops or slows down the drug infusion and begins with emergency medical treatment.

What Precautions Need to be Followed Before Using Iron Sucrose Injection?

• The doctor must be informed about any history of allergic reactions to Iron sucrose injection, its ingredients, or other drugs, such as Iron dextran, Ferumoxytol, sodium ferric gluconate, or any of the drug ingredients.

• The doctor should also be informed about any medical history or condition.

• The doctor must also know about all the non-prescription and prescription drugs that one is taking or planning to take, including nutritional supplements, herbal products, or vitamins that a person is taking or planning to consume. One must specifically mention iron supplements that they are taking orally. This is because a doctor might need to change the drug dosage or monitor the patient carefully for any adverse effects.

• One must inform the doctor if they are pregnant, planning to get pregnant, or breastfeeding. They should also inform the healthcare provider if they get pregnant while taking the treatment with an Iron sucrose injection.

What Are the Side Effects of Iron Sucrose Injection?

Common Side Effects:

• Muscle cramps.

• Constipation.

• Fever.

• Loss of energy.

• Pain in the back, arm, or leg.

• Pain in the ear.

• Injection site burning, soreness, and redness.

• Change in taste.

• Swelling, redness, or pain in the joints.

Serious Side Effects:

• Chest pain.

• Hypertension or high blood pressure.

• Hypotension or low blood pressure.

• Diarrhea (watery stools).

Drug Dosage and Administration

Administration:

Iron sucrose injection is only administered intravenously by slow injection or by infusion. The dosage of Iron sucrose injection is expressed in milligrams of elemental iron, where each milliliter contains 20 milligrams (mg) of elemental iron.

Adult Patients with Hemodialysis Dependent (HDD)-CKD:

The drug is administered 100 milligrams undiluted in the form of a slow intravenous (IV) injection over two to five minutes. It can also be administered as an infusion of 100 milligrams diluted in a maximum of 100 milligrams of 0.9 percent Sodium chloride over at least 15 minutes per consecutive hemodialysis (the process of filtering one’s blood when one's kidneys do not function) session. The injection should be administered early during the dialysis session within the first hour). The total treatment course for iron sucrose injection is 1000 milligrams. The doctor may repeat the treatment if iron deficiency reoccurs.

Adult Patients with Non-Dialysis Dependent (NDD)-CKD:

Administer Iron sucrose injection of 200 milligrams (undiluted) slowly through an intravenous route over two to five minutes or in an infusion form of 200 milligrams in a maximum of 100 mL of 0.9 percent sodium chloride over 15 minutes. Administer on five different occasions over 14 days. Also, experience administering an infusion of 500 milligrams of Iron sucrose, diluted in a maximum of 250 mL (milliliters) of 0.9 percent sodium chloride, is limited throughout 3.5 to four hours on the first day and Day 14. The doctor may repeat the treatment if iron deficiency reoccurs.

Adult Patients with Peritoneal Dialysis Dependent (PDD)-CKD:

The drug should be administered in three divided doses through slow intravenous infusion within 28 days: Two infusions each of 300 milligrams (mg) over 1.5 hours, approximately 14 days apart. The next dose is followed by a 400 mg infusion over 2.5 hours after 14 days. The drug is diluted in 250 mL of 0.9 percent sodium chloride. The Iron sucrose injection treatment may be repeated in case iron deficiency reoccurs.

Pediatric Patients with Hemodialysis Dependent (HDD)-CKD for Iron Maintenance Treatment (2 Years of Age and Older):

• Maintenance Dose - The drug is administered at 0.5 milligrams per kilogram (mg/kg). The dosage (undiluted) should be at most 100 milligrams (mg) per dose every two weeks for 12 weeks. It should be given slowly through intravenous injection over five minutes or diluted in 0.9 percent Sodium chloride at a concentration of one to two milligrams per milliliter (mg/mL) and administered over five to 60 minutes. The concentrations should not be diluted below one mg/mL. Treatment with Iron sucrose injection may be repeated if necessary.

• Iron Replacement Treatment - The dosage in pediatric HDD-CKD patients has yet to be established.

Pediatric Patients (Two Years of Age or Older) with NDD-CKD or PDD-CKD who are on Erythropoietin Therapy for Iron Maintenance Treatment -

• Iron Maintenance Treatment: The Iron sucrose injection is administered at a dose of 0.5 mg/kg, which should not exceed 100 milligrams per dose, every four weeks for about 12 weeks, given in an undiluted form by slow IV or intravenous injection over five minutes or in a diluted form in 0.9 percent Sodium chloride at a concentration of one to two milligram per milliliters (mg/mL), administered over five to 60 minutes. The concentration should not be diluted to concentrations below one mg/mL. Iron sucrose injection treatment may be repeated if necessary.

• Iron Replacement Treatment - The dosage in pediatric patients with NDD-CKD or PDD-CKD has yet to be established.

Missed Dose

If one misses an appointment with the doctor to receive the dose of Iron sucrose injection, they must contact the healthcare provider immediately.

Overdose

In case of an overdose from Iron sucrose injection, one must inform the poison control department immediately. Suppose a person has seizures (an uncontrollable electrical activity in the brain), collapses, or has trouble breathing. In that case, they must be rushed to the nearest hospital or healthcare center to avail of emergency medical services.

Drug Storage and Disposal

NOTE: Iron sucrose injections are given to patients in clinical or hospital settings; therefore, they should not be stored at home.

The drug is stored in its original carton at 25 degrees Celsius or 77 degrees Fahrenheit. Excursions are permitted to 15 to 30 degrees Celsius or 59 to 86 degrees Fahrenheit. Avoid freezing the drugs.

The hospital administration should safely discard the expired or unneeded drug vials to ensure they are not accidentally given to the patient. Hospital authorities usually discard these medications by contacting the local garbage or recycling department or disposing of them by following FDA (Food and Drug Administration) guidelines and protocols for safe drug disposal.

For Doctors

Clinical Pharmacology:

Mechanism of Action

Iron sucrose injection is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Thus, after intravenous (IV) administration, the drug is dissociated into iron and sucrose, and the iron is transported as a complex with transferrin to target cells, such as erythroid precursor cells. The iron in the precursor cells is further incorporated into hemoglobin as the cells start maturing into red blood cells.

Pharmacodynamics

After intravenous (IV) administration, the drug is dissociated into iron and sucrose. Studies show that patients undergoing hemodialysis and also receiving recombinant human erythropoietin therapy, after getting treated with Iron sucrose, containing 100 milligrams of iron, three times weekly for three weeks, show significant decreases in total iron binding capacity and significant increases in serum iron and serum ferritin in four weeks from the initiation of Iron sucrose treatment.

Pharmacokinetics

• Absorption: High serum iron levels are achieved following intravenous administration of Iron sucrose injection. The maximum levels are achieved after ten minutes of IV administration with an average of 30 milligrams per liter.

• Distribution: The drug's volume of distribution is 7.3 Liters. It is mainly distributed in the blood and extracellular fluids.

• Metabolism: After IV (intravenous) administration, the drug gets dissociated into iron and sucrose through the reticuloendothelial system.

• Elimination: The iron gets excreted in a very small portion via renal excretion, around five percent in four hours. Around 68 to 75 percent of sucrose is excreted via renal elimination in around 24 hours. The half-life of the Iron sucrose injection is approximately six hours, and the total body clearance rate is 20.5 milliliters per minute (mL/min).

Ingredients

Active Ingredients: Iron sucrose.

Inactive Ingredients: Water.

Contraindications

The drug is contraindicated in patients who have a history of hypersensitivity reactions to Iron sucrose injections.

Warnings and Precautions

• Hypersensitivity Reactions: The drug has a known history of increased hypersensitivity reactions, such as fatal or life-threatening anaphylactic-type reactions, reported in patients receiving Iron sucrose injections. Patients often present with loss of consciousness, shock, hypotension (low blood pressure), and collapse. Therefore, if signs or symptoms of intolerance or hypersensitivity reactions are witnessed during administration, the doctor should stop Iron sucrose injection immediately. They should be carefully monitored for any signs and symptoms of hypersensitivity during and after Iron sucrose injection administration for at least 30 minutes or until the patient stabilizes clinically following the completion of the drug dose infusion. Also, the doctor should ensure that they administer the drug to the patient only when therapies and adequate staff are immediately available in case of any serious hypersensitivity reactions. Healthcare providers should be careful as most adverse reactions related to IV or intravenous iron preparations usually occur within 30 minutes of drug infusion completion.

• Iron Overload: Iron overload can also occur due to excessive therapy with parenteral iron, leading to excess iron storage and the possibility of iatrogenic hemosiderosis. Therefore, patients (adult and pediatric) receiving Iron sucrose therapy need to be periodically monitored for hematologic and iron parameters, such as hemoglobin, serum ferritin, hematocrit, and transferrin saturation. Also, doctors should not administer the drug to patients with known evidence of iron overload as transferrin saturation (TSAT) values elevate rapidly after IV administration of Iron sucrose. Additionally, doctors should not perform serum iron measurements post-IV dosing for at least 48 hours.

• Hypotension: Iron sucrose injection may cause hypotension (low blood pressure). Therefore, doctors should carefully monitor the patient for signs and symptoms of hypotension after administering Iron sucrose injection (each dose). The hypotension following administration of the drug may be related to the total dose and rate of administration.

Drug Interactions

• Benazepril.

• Carbonyl iron.

• Captopril.

• Enalapril.

• Dimercaprol.

• Ferric maltol.

• Ferrous gluconate.

• Fosinopril.

• Heme iron polypeptide.

• Iron polysaccharide.

• Lisinopril.

• Multivitamin with iron.

• Multivitamin, prenatal.

• Perindopril.

• Ramipril.

• Vitamin E.

• Chloramphenicol

• Enalaprilat.

• Ferrous fumarate.

• Ferrous sulfate.

• Gallium citrate ga-67.

• Iron bis-glycinate.

• Iron protein succinylate.

• Moexipril.

• Multivitamins with iron and fluoride.

• Oxidronate.

• Quinapril.

• Trandolapril.

Uses in Specific Populations

Pregnancy

No adequate studies show the drug's effects in pregnancy. Animal studies have shown no evidence of harm to the fetus or impaired fertility. However, the safety and efficacy of the drug in animals are not always predictive of human response to any drug. Therefore, doctors should prescribe Iron sucrose injections carefully in such cases.

Breastfeeding

Animal studies reveal that drugs get excreted in their milk. However, whether the drug is excreted in human milk is not yet established. Therefore, doctors must prescribe the drug to nursing mothers carefully, as most of the drugs are found in human milk.

Pediatric Use

The safety and effectiveness of iron sucrose injection in the pediatric population are not yet known.

Geriatric Use

Clinical studies on Iron sucrose injection do not have enough volunteers 65 years and above to establish whether the drug works differently in this population. However, doctors are generally recommended to select drug dosage for this population cautiously, starting from a low dose first, depending on the patient’s hepatic, renal, and cardiac function and the drug therapy.