WHAT IS FERCAYL?
Fercayl is an iron replacement product that is used to treat iron deficiency, such as anemia (not enough iron in the blood) or blood loss in patients with certain conditions (eg, hemophilia, gastrointestinal bleeding).
Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.
Fercayl is to be given only by or under the direct supervision of your doctor.
For adults only.
Fercayl is indicated for the treatment of iron deficiency in the following
Indications: When oral iron preparations cannot be used, e.g. due to intolerance, or in case of demonstrated lack of effect of oral iron therapy.
Where there is a clinical need to deliver iron rapidly to iron stores. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Serum ferritin, serum iron, transferrin saturation and hypochromic red cells).
How should I use Fercayl?
Use Fercayl as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Fercayl is usually administered as an injection at your doctor’s office or clinic. Ask your doctor or pharmacist any questions you may have about Fercayl.
Do not use Fercayl if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Fercayl, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Fercayl.
Uses of Fercayl in details
This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.
How to use Fercayl
Follow all directions on the product package, or take as directed by your doctor. Do not take more than the recommended dosage. If you have any questions, ask your doctor or pharmacist.
Iron is best absorbed on an empty stomach (usually if taken 1 hour before or 2 hours after meals). If stomach upset occurs, you may take this medication with food. See the instructions below for the liquid drops for infants/children. Avoid taking antacids, dairy products, tea, or coffee within 2 hours before or after this medication because they will decrease its effectiveness.
Take tablets or capsules with a full glass of water (8 ounces or 240 milliliters) unless otherwise directed by your doctor. Do not lie down for 10 minutes after taking your tablet or capsule dose.
Swallow extended-release capsules whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
If you are taking chewable tablets, chew the medication thoroughly, then swallow.
If you are taking a liquid suspension form of this medication, shake the bottle well before each dose.
If you are taking the liquid form for adults, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Mix the dose in a glass of water or juice, and drink the mixture through a straw to prevent staining the teeth.
If you are giving the liquid drops to an infant or child, use the dropper provided to carefully measure the dose. The dose may be placed directly into the mouth (towards the back of the tongue) or it may be mixed in formula (not milk), fruit juice, cereal, or other food as directed to increase your child’s acceptance. It is best to give this medication right after a meal. Follow the directions on the product package for the brand that you use.
Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.
Fercayl is a dark brown, slightly viscous liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Fercayl is used for the treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible.
Test Dose: (All routes of administration).
Before administering the first dose to a new patient, a test dose of Fercayl corresponding to 25 mg iron or equal to 0.5 mL solution must be administered. If no adverse reactions are seen after 60 minutes, the remaining dose can be given.
Anaphylactoid reactions to Fercayl are usually evident within a few minutes, and close observation is necessary to ensure recognition. If at any time during the intravenous administration of Fercayl, any signs of a hypersensitivity reaction or intolerance are detected, administration must be stopped immediately.
Resuscitative medication and personnel trained to evaluate and resuscitate anaphylaxis should be available whenever a dose of Fercayl is administered.
Elderly: The total cumulative dose of Fercayl is determined by haemoglobin level and body weight. The dose and dosage schedule for Fercayl must be individually estimated for each patient based on a calculation of the total iron deficit.
Children (Under 14 Years): Fercayl should not be used for children. There is no documentation for efficacy and safety.
Dosage: The normal recommended dosage schedule is 100-200 mg iron corresponding to 2-4 mL, two or three times a week depending on the haemoglobin level. However, if clinical circumstances require rapid delivery of iron to the body iron stores Fercayl may be administered as a total dose infusion up to a total replacement dose corresponding to 20 mg iron/kg body weight.
The Fercayl injection should not be administered concomitantly with oral iron preparations as the absorption of oral iron will be reduced.
Intravenous Drip Infusion:
Fercayl must be diluted only in 0.9% sodium chloride solution (normal saline) or in 5% glucose solution. Fercayl in a dose of 100-200 mg iron (2-4 mL) may be diluted in 100 mL. On each occasion the first 25 mg of iron should be infused over a period of 15 minutes. If no adverse reactions occur during this time the remaining portion of the infusion should be given at an infusion rate of not more than 100 mL in 30 minutes.
Fercayl may be administered in a dose of 100-200 mg iron (2-4 mL) by slow intravenous injection (0.2 mL/min) preferably diluted in 10-20 mL 0.9% sodium chloride or 5% glucose solution. On each occasion before administering a slow intravenous injection, 25 mg of iron should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes, the remaining portion of the injection may be given.
Total Dose Infusion: Immediately before administration the total amount of Fercayl required, determined from the dosage table or by calculation, is added aseptically to the required volume, usually 500 mL of sterile normal sodium chloride or 5% glucose solutions. The total amount of Fercayl, up to 20 mg/kg bodyweight, is infused intravenously over 4-6 hours. The first 25 mg of iron should be infused over a period of 15 minutes. The patient must be kept under close medical observation during this period. If no adverse reactions occur during this time, then the remaining portion of the infusion should be given. The rate of infusion may be increased progressively to 45-60 drops per minute. Patients should be observed carefully during the infusion and for at least 1 hour after completion.
Total Dose Infusion (TDI) has been associated with an increased incidence of adverse reactions, in particular delayed hypersensitivity-like reactions. The intravenous administration of Fercayl by the total dose infusion method should be restricted to hospital use only.
Injection into Dialyser: Fercayl may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as outlined for intravenous administration.
Following a test dose prior to the first injection the entire dose is administered at once for subsequent intramuscular injections. The total amount of Fercayl required is determined either from the dosage table or by calculation. It is administered as a series of undiluted injections of up to 100 mg iron (2.0 mL) each determined by the patient’s body weight. If the patient is moderately active, injections may be given daily into alternate buttocks. In inactive or bedridden patients, the frequency of injections should be reduced to once or twice weekly.
Fercayl must be given by deep intramuscular injection to minimise the risk of subcutaneous staining.
It should be injected only into the muscle mass of the upper outer quadrant of the buttock – never into the arm or other exposed areas. A 20 – 21 gauge needle at least 50 mm long should be used for normal adults. For obese patients the length should be 80 – 100 mm whereas for small adults a shorter and smaller needle (23 gauge x 32 mm) is used. The patient should be lying in the lateral position with the injection site uppermost, or standing bearing their weight on the leg opposite the injection site. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Fercayl is injected slowly and smoothly. It is important to wait for a few seconds before withdrawing the needle to allow the muscle mass to accommodate the injection volume. To minimise leakage up the injection track, the patient should be encouraged not to rub the injection site.
Calculation of Dose: Iron Replacement in Patients with Iron Deficiency Anaemia: Factors contributing to the formula are shown below. The required dose has to be individually adapted according to the total iron deficit calculated by the following formula-haemoglobin in g/L or mmol/L.
Total Dose (mg Fe)-Hb in g/L: (Body weight (kg) x (target Hb – actual Hb) (g/L) x 0.24) + mg iron for iron stores.
The Factor 0.24 is Derived from the Following Assumptions: Blood volume 70 mL/kg of body weight ≈ 7% of body weight; Iron content of haemoglobin 0.34%.
Factor 0.24=0.0034 x 0.07 x 1000 (conversion from g to mg).
Total Dose (mg Fe)-Hb in mmol/L: Body weight in kg x (target Hb in mmol/L – actual Hb in mmol/L) x 3.84 + mg iron for iron stores.
The Factor 3.84 is Derived from the Following Assumptions: Blood volume 70 mL/kg of body weight ≈ 7% body weight; Iron content of haemoglobin 0.34%; Factor for conversion from haemoglobin g/L to mmol/L is 0.06205.
Factor 3.84 = 0.0034 x 0.07 x 1000 / 0.06205.
The Table shows the number of millilitres of Fercayl injection solution to be used at various degrees of iron deficiency anaemia.
The figures in the table below are based on a target haemoglobin of 150 g/L or 9.3 mmol/L and iron stores of 500 mg which apply to a body weight exceeding 35 kg.
Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. This total iron requirement reflects the amount of iron needed to restore haemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of haemoglobin. It should be remembered that iron deficiency anaemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of haemoglobin iron but of iron stores as well.
If the total necessary dose exceeds the maximum allowed daily dose, the administration has to be split. Evidence of a therapeutic response can be seen within a few days of administration of Fercayl as an increase in the reticulocyte count. Serum ferritin levels usually provide a good guide to the replenishment of iron stores. In renal dialysis patients receiving Fercayl, this correlation may not be valid.
Iron Replacement for Blood Loss: Iron therapy in patients with blood loss should be directed toward replacement of an amount of iron equivalent to the amount of iron represented in the blood loss. The table and formula described are not applicable for simple iron replacement values. Quantitative estimates of the individual’s periodic blood loss and hematocrit during the bleeding episode provide a convenient method of calculation of the required iron dose.
The required Fercayl dose to compensate the iron deficit is calculated according to the following formulas: If the volume of blood lost is unknown: The administration of 200 mg i.v. iron [4 mL Fercayl] results in an increase of haemoglobin which is equivalent to 1 unit blood (= 400 mL with 150 g/L Hb content or 9.3 mmol Hb/L – equivalent to 0.34% of 0.4 x 150 or 204 mg iron).
Iron to be replaced [mg] = number of blood units lost x 200.
Millilitres of Fercayl needed = number of blood units lost x 4.
If the Hb level is reduced: Use the previous formula considering that the depot iron does not need to be restored.
Mg iron to be replaced = body weight (kg) x 0.24 x (target Hb in g/L – actual Hb in g/L).
Mg iron to be replaced = body weight (kg) x 3.84 x (target Hb in mmol/L – actual Hb in mmol/L).
E.g.: body weight 60 kg, Hb deficit = 10 g/L or 0.62 mmol/L: Iron to be replaced = 60 x 0.24 x 10 = 60 x 3.84 x 0.62 = 143 mg [≈ 3 millilitres Fercayl]
Administration: Fercayl solution for infusion and injection can be administered by an intravenous drip infusion or by a slow intravenous injection of which the intravenous drip infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes. However, Fercayl may also be administered as undiluted solution intramuscularly.
Drug/Laboratory Test Interactions
Large doses of Fercayl (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration.
The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Fercayl.
Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Fercayl and slowly returns to baseline after about 3 weeks.
Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following Fercayl therapy because residual Fercayl may remain in the reticuloendothelial cells.
Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of Fercayl.
Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following Fercayl infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.
Fercayl side effects
Severe/Fatal: Anaphylactic reactions have been reported with the use of Fercayl injection; on occasions these reactions have been fatal. Such reactions, which occur most often within the first several minutes of administration, have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. Because fatal anaphylactic reactions have been reported after administration of Fercayl injection, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.
Cardiovascular: Chest pain, chest tightness, shock, cardiac arrest, hypotension, hypertension, tachycardia, bradycardia, flushing, arrhythmias. (Flushing and hypotension may occur from too rapid injections by the intravenous route.)
Dermatologic: Urticaria, pruritus, purpura, rash, cyanosis.
Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea.
Hematologic/lymphatic: Leucocytosis, lymphadenopathy.
Musculoskeletal/soft tissue: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis – See PRECAUTIONS: General), myalgia; backache; sterile abscess, atrophy/fibrosis (intramuscular injection site); brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites; cellulitis; swelling; inflammation; local phlebitis at or near intravenous injection site.
Neurologic: Convulsions, seizures, syncope, headache, weakness, unresponsiveness, paresthesia, febrile episodes, chills, dizziness, disorientation, numbness, unconsciousness.
Respiratory: Respiratory arrest, dyspnea, bronchospasm, wheezing.
Delayed reactions: Arthralgia, backache, chills, dizziness, fever, headache, malaise, myalgia, nausea, vomiting.
Miscellaneous: Febrile episodes, sweating, shivering, chills, malaise, altered taste.
Cases of severe, sometimes fatal, allergic reactions (loss of consciousness, collapse, difficulty breathing, hives, swelling, or convulsions) and severe low blood pressure (hypotension) have been reported with the use of Fercayl. This medication should be administered under the supervision of a healthcare professional.