Ferisen

Carbofer injection is indicated for the treatment of iron deficiency anemia in adult patients:
who have intolerance to oral iron or have had unsatisfactory response to oral iron.
who have non-dialysis dependent chronic kidney disease.

Dosage & Administration

The posology of Ferric Carboxymaltose follows a stepwise approach:
determination of the individual iron need
calculation and administration of the iron dose(s)
post-iron repletion assessments.
Step 1: Determination of the iron need:
The individual iron need for repletion using Fematos is determined based on the patient's body weight and haemoglobin (Hb) level. The following list for determination of the iron need:
Hb <10 g/dl
below 35 kg: 500 mg
35 kg to <70 kg: 1500 mg
70 kg and over: 2000 mg
Hb 10 to 14 g/dl
below 35 kg: 500 mg
35 kg to <70 kg: 1000 mg
70 kg and over: 1500 mg
Hb >14 g/dl
below 35 kg: 500 mg
35 kg to <70 kg: 500 mg
70 kg and over: 500 mg
Step 2: Calculation and administration of the maximum individual iron dose(s)
: Based on the iron need determined above the appropriate dose(s) of Ferric Carboxymaltose should be administered taking into consideration the following:
A single Ferric Carboxymaltose administration should not exceed:
15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
1,000 mg of iron (20 ml Ferric Carboxymaltose)
The maximum recommended cumulative dose of Ferric Carboxymaltose is 1000 mg of iron per week.
Step 3: Post-iron repletion assessments
: Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Ferric Carboxymaltose administration to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using above list.

The side effects of Carbofer are infrequent, usually mild & generally do not cause patients to stop treatment.
The most common side effect
: nausea, followed by headache, dizziness, and hypertension, injection site reactions, nausea, alanine aminotransferase increased, hypophosphataemia.
Uncommon side effects
: hypersensitivit, dysgeusia, tachycardia, hypotension, flushing, dyspnoea, dyspepsia, abdominal pain, constipation, diarrhea, Pruritus, urticaria, erythema, rash, myalgia, back pain, arthralgia, muscle spasms, Pyrexia, fatigue, chest pain, oedema peripheral, chills, aspartate aminotransferase increased, gamma glutamyl transferase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased.
Rare side effects
: anaphylactoid reactions, loss of consciousness, anxiety, phlebitis, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise, influenza like illness.

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Carbofer. Patients may present with shock, clinically significant hypotension, loss of consciousness and collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Carbofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Carbofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus,rash, urticaria, wheezing, or hypotension may occur.
Hypertension
: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea may be occured. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Carbofer administration.
Laboratory Test Alterations
: In the 24 hours following administration of Carbofer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Carbofer.