Ferric gluconate (Ferrlecit) is an intravenous formulation available for the treatment of iron deficiency anemia in patients with chronic kidney disease.

Ferric gluconate Uses:

• Iron deficiency anemia:

  • Used for the treatment of iron-deficiency anemia in patients 6 years and older with chronic kidney disease undergoing hemodialysis in conjunction with supplemental erythropoietin therapy

• Off Label Use of Ferric gluconate in Adults:

  • Used in iron deficiency anemia (in nondialysis patients unresponsive to or poorly tolerant of oral iron therapy).

Ferric gluconate (Ferrlecit) Dose in Adults

Note: A test dose of 2 mL diluted in NS 50 mL administered over 60 minutes was previously recommended (not in current manufacturer labeling.

Ferric gluconate (Ferrlecit) Dose in the treatment of Iron-deficiency anemia in hemodialysis patients:

• 125 mg (elemental iron) IV per dialysis session.
• For repletion treatment, the majority of the patients may require a cumulative dose of 1,000 mg (elemental iron) over ~8 dialysis sessions.
• Off-label dosing (based on limited data):
  • After establishing tolerance of the 125 mg dose (elemental iron), single doses of up to 250 mg (elemental iron) have been reported to be safe and well-tolerated in hemodialysis patients.

Ferric gluconate (Ferrlecit) Dose in the treatment of Iron-deficiency anemia (in non-dialysis patients unresponsive to or poorly tolerant of oral iron therapy) (off-label):

• IV: 125 to 250 mg elemental iron per dose;
• The treatment is repeated until hematologic parameters or total iron requirements are met.

Ferric gluconate (Ferrlecit) Dose in Chemotherapy-associated anemia (off-label):

• IV infusion: 125 mg one time per week for 6 doses OR for 8 doses.

Ferric gluconate (Ferrlecit) Dose in Children

Multiple forms of parenteral iron are available for use. The dosing and administration of each iron formulation differ. The dose and duration of each parenteral formulation should be appropriately selected to avoid overdosing or underdosing. Test dosages are advised prior to beginning the medication.

Note:

• According to the National Kidney Foundation DOQI Guidelines, the Hb level, the dose of the erythropoietin stimulating agent, and the results of the iron status tests should all be taken into consideration when deciding on the dose, starting the iron treatment, and the length of the therapy.
• If the ferritin level is greater than 500 ng/mL, there is not enough data to warrant IV iron. The doses listed below are represented in milligrams of elemental iron.

Ferric gluconate (Ferrlecit) Dose in the treatment of Iron-deficiency anemia in hemodialysis patients, repletion:

• Children ≥6 years and Adolescents:

  • 1.5 mg/kg (0.12 mL/kg) intravenously repeated at each of 8 sequential dialysis sessions;
  • The maximum dose: is 125 mg/dose

Ferric gluconate (Ferrlecit) Dose in the maintenance treatment of Iron-deficiency anemia in hemodialysis patients:

• Children ≥6 years and Adolescents <17 years:

  • Initial: 1 mg/kg/dose once weekly during the dialysis session.
  • Adjust dose to desired iron indices (reported range: 0.75 to 1.5 mg/kg/dose);
  • The maximum dose: 125 mg/dose.

Pregnancy Risk Factor B

• Anemia (Iron Deficiency Anemia) and iron deficiency (IDA), if left untreated in a pregnant woman, can lead to adverse events such as low birth weight, preterm births, or higher perinatal mortality.
• Treatment of iron deficiency (or IDA) in pregnancy is generally the same as for non-pregnant women.
• In animal reproduction studies, adverse events were not seen.
• During pregnancy, maternal iron requirements rise.
• Affective iron levels can be maintained for the foetus regardless of maternal iron status.
• Most studies show iron therapy improves maternal hemoglobin parameters. However, there is not much information on the clinical outcomes of iron therapy in neonates and mothers.
• Usually, oral iron supplements are adequate. Nonetheless, parenteral iron treatment can be utilized to treat females who are unable or unwilling to take oral iron in situations of severe iron shortage or malabsorption.
• Some preparations may contain benzyl Alcohol (to avoid pregnancy and the association with gasping syndrome in premature infants)
• Because of limited safety data, intravenous iron should not be started before the second or third trimester. The information regarding the use of ferric gluconate during pregnancy is not available.

Ferric gluconate use during breastfeeding:

• Breast milk contains iron.
• Preparations may contain benzyl alcohol, so it is important to be cautious when ferric gluconate has been given to nursing women.
• Iron levels in breast milk are maintained for women with mild to moderate iron deficiency (IDA). However, concentrations may drop if IDA becomes severe.
• It is unknown if breast milk concentrations are affected by maternal ferric gluconate use.

Dose in Kidney Disease:

• The manufacturer's labeling doesn't provide any dosage adjustments.
• The ferric gluconate iron complex is not dialyzable.

Dose in Liver disease:

The manufacturer's labeling doesn't provide any dosage adjustments.

Percentages reported in adults unless otherwise noted.

Common Side Effects of Ferric gluconate (Ferrlecit):

• Cardiovascular:

  • Hypertension
  • Tachycardia
  • Hypotension

• Central Nervous System:

  • Dizziness
  • Headache

• Gastrointestinal:

  • Nausea
  • Diarrhea
  • Vomiting

• Hematologic & Oncologic:

  • Abnormal Erythrocytes

• Local:

  • Injection Site Reaction

• Neuromuscular & Skeletal:

  • Muscle Cramps

• Respiratory:

  • Dyspnea

Less Common Side Effects Of Ferric Gluconate:

• Cardiovascular:

  • Chest Pain
  • Syncope
  • Thrombosis
  • Vasodilatation
  • Edema
  • Angina Pectoris
  • Bradycardia
  • Myocardial Infarction
  • Peripheral Edema

• Central Nervous System:

  • Pain
  • Fatigue
  • Impaired Consciousness
  • Malaise
  • Rigors
  • Paresthesia
  • Agitation
  • Chills
  • Drowsiness

• Dermatologic:

  • Diaphoresis
  • Skin Rash
  • Pruritus

• Endocrine & Metabolic:

  • Hypervolemia
  • Hypoglycemia
  • Hypokalemia
  • Hyperkalemia
  • Hypermenorrhea

• Gastrointestinal:

  • Abdominal Pain
  • Rectal Disease
  • Anorexia
  • Dyspepsia
  • Eructation
  • Flatulence
  • Gastrointestinal Disease
  • Melena

• Genitourinary:

  • Urinary Tract Infection

• Hematologic & Oncologic:

  • Leukocytosis
  • Lymphadenopathy
  • Anemia
  • Carcinoma

• Infection:

  • Infection
  • Sepsis
  • Abscess

• Neuromuscular & Skeletal:

  • Leg Cramps
  • Weakness
  • Myalgia
  • Arm Pain
  • Arthralgia
  • Back Pain

• Ophthalmic:

  • Conjunctivitis
  • Nystagmus
  • Watery Eyes
  • Corneal Changes
  • Diplopia
  • Eye Redness
  • Eyelid Edema

• Otic:

  • Deafness

• Respiratory:

  • Pharyngitis
  • Cough
  • Pulmonary Edema
  • Rhinitis
  • Upper Respiratory Tract Infection
  • Flu-Like Symptoms
  • Pneumonia

• Miscellaneous:

  • Fever

Contraindications to Ferric gluconate (Ferrlecit):

Hypersensitivity to ferricgluconate or any other component of the formulation

Warnings and precautions

• Hypotension

  • Hypotension can be clinically significant. Usually resolves in 1 to 2 hours. Hypotension may be increased by hemodialysis.

• Hypersensitivity reactions

  • Severe hypersensitivity reactions have been reported, including anaphylactic-type reactions. These reactions can be life-threatening.
  • Always have equipment for resuscitation available and personnel who are trained in handling medical emergencies.
  • You may experience shock, severe hypotension, loss of consciousness, or even collapse.
  • Monitor for at least 30 minutes during administration, and for more than 30 minutes following administration. Continue monitoring until the patient is stable.
  • Avoid rapid administration.

Ferric gluconate: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• Monitor hemoglobin and hematocrit, iron saturation, and serum ferritin;
• vital signs;
• monitor for signs and symptoms of hypersensitivity (monitor for at least 30 minutes following the end of the administration and until clinically stable)

Chronic kidney disease:

• Monitor transferrin saturation and ferritin more frequently following a course of IV iron.

Chemotherapy-linked anemia (off-label use):

• Levels of ferritin, total iron-binding capacity, transferrin saturation, or iron at baseline and on a regular basis.

How to administer Ferric gluconate (Ferrlecit)?

• It is administered intravenously diluted over one hour or undiluted (slowly) at a rate of up to 12.5 mg/minute per dialysis session.
• The 250 mg dose (off-label) has been infused (diluted) over 1 to 2 hours.

Mechanism of action of Ferric gluconate (Ferrlecit):

It provides a source of elemental iron that is required for the functioning of myoglobin and hemoglobin as well as specific enzyme systems. It allows for the transport of oxygen via hemoglobin

Half-life elimination:

• Bound iron: 1 hour

International Brand Names of Ferric gluconate:

• Ferrlecit
• Ladyline
• Efecient
• Ferritin Oti
• Fu-Iron

Ferric gluconate Brand Names in Pakistan:

Brands available in Pakistan will be updated later.

Read: Venofer (Iron sucrose) Injection