Sodium Ferric Gluconate Complex (intravenous route)

Sodium Ferric Gluconate Complex replaces iron in children and adults who are currently receiving dialysis for an underlying kidney disease.

Overview

Sodium Ferric Gluconate Complex helps to prevent and resolve anemia caused by iron deficiency, particularly in patients undergoing dialysis with supplemental epoetin therapy. These treatments deplete iron levels as a result of blood loss or excessive use of iron reserves. To resolve, doctors prescribe Sodium Ferric Gluconate Complex.

Ferrlecit is available by prescription only and via an intravenous route of application – completed by a nurse in most cases within a clinical or hospital setting. When prescribed, healthcare specialists run a number of tests to determine if the treatment is working as it should.

Why Is Iron Important?

We rely on iron to maintain a healthy supply of red blood cells, which are responsible for transporting oxygen to vital organs throughout the body, including the liver, bone marrow, and spleen. The process of iron regeneration is called hemoglobin synthesis.

More Insight on Iron

Most healthy adults, on average, store 2-4 grams of iron, according to the FDA. In healthy adults, the iron levels diminish slowly over time at a rate of 0.03% per day. During the course of a dialysis treatment with epoetin therapy, the reserves are depleted expeditiously.

Every patient is different, and as a result, the treatment amounts vary depending on blood tests results taken before and after treatments with Sodium Ferric Gluconate Complex.

Some treatments are single-dose only while others are scheduled for each session of dialysis, depending on the patient’s unique medical needs.

Conditions Treated

  • Anemia
  • Iron Deficiency
  • Iron Shortage

Type Of Medicine

  • Iron Replacement

Side Effects

As with all medicines, Ferrlecit may cause unwanted side effects, some more serious than others. In most cases, however, adverse side effects subside with time and the most commonly reported include:

  • Diarrhea
  • Feeling Dizzy or Faint
  • Feeling Nauseous
  • Headache
  • High Blood Pressure
  • Leg Cramps
  • Low Blood Pressure
  • Pain at the Site of the Injection
  • Upset Stomach
  • Vomiting

If these or any other symptoms are noticeable, inform your medical provider. An altered dose may be required to ensure the medicine is better tolerated.

Some of the Less Common Side Effects of Ferrlecit Include:

  • An Overall Feeling of Sickness
  • A Reduction in Urinary Output
  • Abnormal Heartbeat - Too Fast or Too Slow
  • Appetite Changes
  • Bleeding
  • Blue Lips or Nails
  • Bruising Easily
  • Changes in the Color of the Urine
  • Changes in the Voice
  • Chills
  • Cold-to-Touch Skin That Is Pale
  • Color Changes in Stools
  • Coma or Loss of Consciousness
  • Cramping In the Legs
  • Cravings or Feeling Hungry All the Time
  • Dehydration
  • Diarrhea
  • Edema or Swelling throughout the Body
  • Fainting or Dizzy Spells
  • Feeling Confused
  • Feeling Nervous or Anxious
  • Feeling Shivery or Shaky
  • Fluctuations in Body Weight
  • Hallucinations
  • Hot Flashes
  • Insomnia
  • Loud or Labored Breathing
  • Lower Belly Pain
  • Mental Health Issues, including Depression
  • Migraines or Headaches
  • Mood Changes
  • Muscle Pain and Swelling
  • Pain and Discomfort in the Stomach
  • Pain in the Joints
  • Pain or Burning While Urinating
  • Pain or Discomfort in the Eyes
  • Parched Lips or Excessive Thirst
  • Red-Colored Skin (Aka Flushing)
  • Ringing or Pounding Sensations in the Ears
  • Seizures or Convulsions
  • Spikes in Temperature
  • Sweating Profusely At Night
  • Tenderness and Pain in the Veins or Lymph Glands
  • Tingling or Numb Sensation
  • Trouble Breathing
  • Vision Changes

As can be seen, Ferrlecit is potent enough to trigger a wide range of adverse side effects. Patients should, therefore, be informed of all the possible side effects of the replacement therapy. In particular, medical practitioners should educate patients on when it’s absolutely necessary to seek medical help right away.

Low Blood Pressure

This medicine could potentially cause sudden drops in blood pressure. Hypotension or low blood pressure comes with the following symptoms:

  • Extreme Fatigue or Weakness
  • Chest Pain
  • Back Pain
  • Pain in the Groin

When hypotension occurs, the symptoms generally dissipate over the course of a few hours. It is otherwise known as transient vs. persistent hypotension; and in these cases, the patient should be monitored closely until the symptoms subside.

Dosage

Ferrlecit is administered into the vein in a hospital setting by a trained and qualified medical worker. The dosage amounts vary according to a patient’s age, weight, medical history, and other factors.

The following table provides approximate amounts of the medicine that are generally prescribed by a healthcare professional:

  • Adults: 10 mL (125 mg elemental iron) | Mixed Into 100 ML of (0.9%) Sodium Chloride
  • Children: 0.12 mL (1.5 mg elemental iron)| per kg Weight | Mixed Into 25 ML of (0.9%) Sodium

Medical workers on duty should verify the individualized dosage before mixing and administering this medicine.

Chloride

The dosage is moreover administered during the course of dialysis treatments. In most cases, the length of treatment is via a slow-drip method lasting up to one hour.

Original vials of Ferrlecit are intended for single use only and are dispensed with 62.5 mg of elemental iron or 5 ML under the U.S. trade name Ferrlecit .

The max dose for each treatment session in both children and adults should not exceed 125 mg of elemental iron.

How to Administer

Some key notes about administering Ferrlecit include:

  • Unlike other trace elements that may be diluted into Trans Parenteral Nutrition IV bags, Ferrlecit differs in that it is given alone (without combining with other medicines).
  • Currently, the concentrations of elemental iron are diluted into (0.9%) Sodium Chloride and no other liquids at this time – as safety has not been established.
  • Medical workers on duty should inspect the mixed solution for quality before administering the IV treatment. Some checkpoints include looking for discoloration or uneven solutions. In these cases, the IV bag should be replaced with a new one.
  • Once the formula has been diluted, it should be used instantly. Any longstanding mixtures should be disposed of and a new one prepared once the patient is ready for treatment.
  • Test assessments are suggested by some medical groups for new patients, which entails giving 2.5 mL (125 mg elemental iron) | Mixed Into 50 ML of (0.9%) Sodium Chloride | for 1 Hour.

Repeat Treatments

Some patients require reoccurring treatments with Sodium Ferric Gluconate Complex. In these events, the recommended dose for adults is:

  • 1000 mg (elemental iron) | 8 sessions of dialysis

Overdose

To measure iron levels accumulated by the patient, lab work is done before and after treatment. Follow-up checks may be necessary to determine this as the treatment provides residual benefits for months at a time – in most cases.

Interactions

Some medicines should not be used with Ferrlecit unless completely necessary. In these circumstances, the dose is typically adjusted or reduced. The most widely reported negative drug interactions with Ferrlecit are:

  • Chloramphenicol
  • Vitamin E

Important Note for Patients: Inform your doctor of any prescriptions you may be taking, not excluding herbal supplements or vitamins, for example.

Food Interactions

Ferrlecit should not be taken with foods or substances that contain Phytic Acid, as contraindications have been found.

Warnings

Ferrlecit comes with a number of warnings, including:

Anaphylaxis Shock

Ferrlecit could trigger a serious allergic reaction or anaphylaxis shock. Be sure to tell your doctor if you have had any past allergies. Medical workers on duty, too, will check patients’ progress and look for warning signs of anaphylaxis shock.

Some telltale signs of anaphylaxis shock include when patients:

  • Feel Dizzy, Lightheaded, or Faint
  • Have Difficulty Breathing or Swallowing
  • Have Sudden Rashes or Hives
  • Look Swollen in One or More Area
  • Coma or Loss of Consciousness

Special Note for Medical Workers: If any of these symptoms occur, the treatment should be immediately stopped and appropriate measures must be taken to treat anaphylaxis shock.

Special Note for Patients: Anaphylaxis shock is a serious and potentially fatal condition that requires immediate medical intervention. Alert your medical provider if you experience any of the above symptoms. A call button is usually on hand during dialysis treatment for alerting medical workers on duty.

Safety Protocols

As this treatment requires injecting a needle into the vein and setting up an IV infusion bag, it is essential for medical staff to follow all safety protocols outlined by the healthcare facility. Some include:

  • Safety Gear: Wearing gloves and other protective gear when handling needles. Doing so reduces the risk of transmission of infectious diseases.
  • Dispose of Used Needles: All needles are for single use only and should be discarded after use into a biohazard container.
  • Adhere to Label Instructions: Dilution of the solution should be completed as prescribed. If unsure, check with a supervisor for help.
  • Prep for Emergencies: In the event that anaphylaxis shock occurs, equipment and counteractive medicines should be available on hand to treat the condition in a timely manner.

After Treatment

Ferrlecit labels explicitly state that patients should be closely monitored for up to a half of an hour following treatment to determine if any hypersensitivities to the treatment happen.

Anemia

Ferrlecit is only intended for anemia caused by iron deficiency. It is not suggested for other types of anemias, which could benefit from more appropriate treatments.

Use in Minors

Ferrlecit is not intended for children who are under the age of 6. In particular, infants under the age of 6 months old may be adversely affected by the benzyl alcohol contents. This is known to cause gasping syndrome in minors.

Use in Pregnant and Nursing Mothers

Ferrlecit should only be prescribed when there is an urgent need to do so and no other safer alternatives are established. This is because the medicine contains benzyl alcohol, which could affect fetuses. Medical studies moreover show that this medicine crosses the placental barrier. The main concern to neonates is the risk of gasping syndrome – one of the primary reasons it is not recommended for children under the age of 6 years old.

Use in Seniors

Senior patients with certain underlying medical conditions may require a reduced dose of Ferrlecit to prevent the condition from worsening. Examples include:

  • Heart Health Issues
  • Liver Disease
  • Renal Impairment

Before commencing this medicine, disclose any underlying health conditions to your medical provider.

Other Preexisting Conditions

Senior patients with underlying medical conditions aren’t the only ones who could experience negative symptoms with the use of Sodium Ferric Gluconate Complex. Individuals who are diagnosed with iron overload or low blood pressure, for example, should be carefully monitored when provided with Sodium Ferric Gluconate Complex.

To prevent adverse side effects, all patients should be screened for underlying conditions that may require changes in dosage. In particular, patients with a demonstrated history of sensitivities or iron overload generally required an altered amount of the medicine.

About Iron Overload

Iron overload happens when the body stores too much of the element, resulting in toxicity. This condition is otherwise known as iatrogenic hemosiderosis and some patients are more susceptible to it than others.

Storage

The vials containing Ferrlecit should always be stored in controlled room temperatures. Read the package insert clearly to ensure the quality of the medicine is preserved.

The average room temperature recommended for storage is 20 – 25°C (68 – 77°F).

Summary

When patients with kidney disease undergo dialysis coupled with epoetin therapy, one of the side effects is iron shortage. A quick way to replace lost iron is with IV infusions of Ferrlecit or Ferrlecit.

Ferrlecit is generally well-tolerated by pediatric, adult, and senior patients. However, it is not recommended for use in infants and children under 6.

As is the case with most medicines, patients should be carefully monitored for any adverse side effects that could occur following treatment. In particular, some of the warning signs to watch for include drops in blood pressure (hypotension) or hypersensitivities. In these events, medical intervention is usually required.

In the end, this therapy replenishes lost iron and aids in the proper functioning of hemoglobin, which is necessary for supplying oxygen to important organs throughout the body.

 

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Last Reviewed:
January 31, 2018
Last Updated:
January 27, 2018
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