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Iron /Ferric Carboxymaltose; Uses, Dosage, Side Effects

Iron /Ferric Carboxymaltose /Iron (III)-hydroxide polymaltose complex is a medication used to treat iron deficiency/iron deficiency anemia and belongs to the group of oral iron preparations. The preparation is a macromolecular complex, consisting of iron(III)-hydroxide (trivalent iron, Fe³⁺) and the carrier polymaltose and is available in solid form as a film-coated or chewable tablet and in liquid form as a syrup, drinkable solution, or drops. It is used for treating iron deficiency without anemia (latent iron deficiency) or with anemia (apparent iron deficiency). Prior to administration, the iron deficiency should be diagnostically established and verified via laboratory tests (e.g., low ferritin concentration, low transferrin saturation).

Mechanism of action of Iron /Ferric Carboxymaltose

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Normal erythropoiesis is dependent on the concentration of iron and erythropoietin available in the plasma. Administration of iron does not stimulate the production of red blood cells, nor does it correct abnormalities not caused by iron deficiency. A therapeutic response to treatment with iron products is dependent on the patient’s ability to absorb and use the iron, and it is influenced by the cause of the deficiency as well as other illnesses that can affect normal erythropoiesis.

Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Iron is a component of myoglobin and several heme-enzymes, including the cytochromes, catalase, and peroxidase. Iron is an essential component of the metalloflavoprotein enzymes and the mitochondrial enzyme alpha-glycerophosphate oxidase. Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Furthermore, iron is a cofactor for enzymes such as aconitase and tryptophan pyrrolase. Iron deficiency not only causes anemia and decreased oxygen delivery, but it also reduces the metabolism of muscle and decreases mitochondrial activity. Iron deficiency can also lead to defects in learning or thermoregulation. Thus iron is important to several metabolic functions which are independent of its importance to erythropoiesis.

Indications of Iron /Ferric Carboxymaltose

Maltofer in oral dosage forms (solution and drops for oral administration, chewing tablets, syrup) is prescribed for the following conditions/diseases

Latent and clinically pronounced iron deficiency (treatment);
Iron deficiency in nursing and pregnant women, children and adolescents, adults (for example, elderly people and vegetarians), women of childbearing age (prevention).
Iron deficiency due to aging or major surgery
Pregnancy & Lactation
Adult men, Adolescent males, and Postmenopausal women
Adolescent menstruating, premenopausal women
To restore hemoglobin and replenish iron stores in iron-deficiency anemia due to causes other than blood loss.
Iron is an important part of your red blood cells and is needed to transport oxygen in the body. Many patients with kidney disease cannot get enough iron from food and require injections.
It is used to replenish body iron stores in Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) patients receiving or not receiving erythropoietin and in Hemodialysis Dependent (HDD-CKD) and Peritoneal Dialysis Dependent (PDD-CKD) – Chronic Kidney Disease patients receiving an erythropoietin

Contraindications of Iron /Ferric Carboxymaltose

Excess of iron (hemosiderosis, hemochromatosis);
Non-iron deficiency anemia (eg, erythropoiesis, hemolytic anemia due to a deficiency in the body of vitamin B12, megaloblastic anemia, bone marrow hypoplasia);
Impaired iron utilization (eg, thalassemia, sideroachrastic anemia, late porphyria of the skin, lead anemia);
Hypersensitivity to the components of the drug.
Infectious hepatitis;
Osler-Randu-Weber Syndrome;
Chronic polyarthritis;
Uncontrolled hyperparathyroidism;
Infectious diseases of the kidneys (in the acute course);
Bronchial asthma;
Decompensated hepatic cirrhosis;
Intravenous introduction;
The first trimester of pregnancy.

When taking the drug inside, because of the need to assign smaller doses, premature infants Maltofer is recommended to use in the form of drops, children under 12 years of age – in the form of syrup. The drug in the form of a solution for injection is not recommended for children up to 4 months (due to lack of data on safety and efficacy of its use in this category of patients).

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A form of issue and composition

Maltofer is produced in the following dosage forms

The solution for ingestion: dark brown (5 ml in glass bottles, 10 bottles in a cardboard bundle);
Drops for ingestion: dark brown (30 ml in dark glass bottles with a dispenser, 1 bottle per carton);
Syrup: dark brown color (150 ml each in dark glass bottles, 1 bottle in a cardboard bundle complete with a measuring cap);
Chewing tablets: flat-cylindrical, with a risk, brown with inclusions of white color (10 pcs in blisters, 3 blisters each in a cardboard bundle);
The solution for injection: brown (2 ml in colorless glass ampoules, 5 ampoules in a cardboard bundle).

The composition of 1 ml solution for oral administration includes

Active substance: iron – 20 mg (in the form of iron (III) hydroxide polymaltose);
Auxiliary components: sucrose, 70% sorbitol solution, sodium methyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate, cream flavor, sodium hydroxide, purified water.

The composition of 1 ml (20 drops) drops for oral administration includes

Active substance: iron – 50 mg (in the form of iron (III) hydroxide polymaltose);
Auxiliary components: sucrose, sodium methyl p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate, cream flavor, sodium hydroxide, purified water.

The composition of 1 ml of syrup is

Active substance: iron – 10 mg (in the form of iron (III) hydroxide polymaltose);
Auxiliary components: sucrose, 70% sorbitol solution, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, 96% ethanol, cream flavors, sodium hydroxide, purified water.

The composition of 1 tablet chewing is

Active substance: iron – 103 mg (in the form of iron (III) hydroxide polymaltose);
Auxiliary components: dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor, microcrystalline cellulose.

The composition of 1 ml solution for injection includes

Active substance: iron – 50 mg (in the form of iron (III) hydroxide polymaltose);
Auxiliary components: sodium hydroxide / hydrochloric acid, water for injection.

Dosages of Iron /Ferric Carboxymaltose

Maltofer in the form of a solution, drops, chewable tablets and syrup are taken orally during or immediately after a meal.

Before taking a drop, the solution and syrup can be mixed with soft drinks or vegetable or fruit juices. Chewable tablets can be swallowed whole or chewed.

The daily dose of the drug is determined by the degree of iron deficiency.

In iron deficiency anemia, the drug is administered in the following dosages

Premature babies: 1-2 drops of solution / kg;
Children under 1 year of age: 25-50 mg of iron – 10-20 drops of the solution or 2.5-5 ml of syrup;
Children 1-12 years: 50-100 mg of iron – 20-40 drops of the solution or 5-10 ml of syrup;
Children from 12 years: 100-300 mg of iron – 40-120 drops of the solution or 10-30 ml of syrup;
Adults (including lactating women): 100-300 mg of iron – 40-120 drops of solution, 10-30 ml of syrup or 1-3 chewable tablets;
Pregnant women: 200-300 mg of iron – 80-120 drops of solution, 20-30 ml of syrup or 2-3 chewable tablets.

With a latent iron deficiency, Maltofer is prescribed

Children under 1 year: 15-25 mg of iron – 6-10 drops of a solution;
Children 1-12 years: 25-50 mg of iron – 10-20 drops of a solution or 2.5-5 ml of syrup;
Children from 12 years: 50-100 mg of iron – 20-40 drops of a solution or 5-10 ml of syrup;
Adults (including lactating women): 50-100 mg of iron – 20-40 drops of solution, 5-10 ml of syrup or 1 chewable tablet;
Pregnant women: 100 mg of iron – 40 drops of solution, 10 ml of syrup or 1 chewable tablet.

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For prophylaxis, the drug is prescribed in the following dosages

Children under 1 year: 15-25 mg of iron – 6-10 drops of the solution;
Children 1-12 years: 25-50 mg of iron – 10-20 drops of a solution or 2.5-5 ml of syrup;
Children from 12 years: 50-100 mg of iron – 20-40 drops of the solution or 5-10 ml of syrup;
Adults (including lactating women): 50-100 mg of iron – 20-40 drops of the solution or 5-10 ml of syrup;
Pregnant women: 100 mg of iron – 40 drops of solution, 10 ml of syrup or 1 chewable tablet.

The daily dose of Maltopher in the form of a solution for oral administration can be taken all at once. In the treatment of iron deficiency anemia adults, children 12 years and nursing mothers are prescribed 1 vial 1-3 times a day, pregnant women 2-3 times a day. For the prevention of iron deficiency and the therapy of latent iron deficiency, adults (including nursing and pregnant women) and children from 12 years should take 1 bottle per day.

Side Effects of Iron /Ferric Carboxymaltose

Most common

Abdominal or stomach discomfort
low blood pressure,
difficult, burning, or painful urination
increased potassium blood levels (hyperkalemia),
low blood sugar (hypoglycemia), and
diarrhea
symptoms of weakness, muscle pain (myalgia)
abdominal pain (GI complaints), lactic acidosis (rare)
low blood levels of vitamin B-12
nausea, vomiting
chest discomfort
chills, dizziness
bloating/abdominal distention
constipation
heartburn

More common

chest pain;
Abdominal or stomach discomfort
a cough or hoarseness
decreased appetite
diarrhea
fast or shallow breathing
feeling like you might pass out;
swelling in your hands, ankles, or feet;
trouble breathing; or
dangerously high blood pressure (a severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure)
lower back or side pain
muscle pain or cramping
painful or difficult urination

Less common

muscle cramps;
weakness, tired feeling;
dizziness, anxiety, headache;
nausea, vomiting, stomach pain;
diarrhea, constipation;
ear pain;
sore throat, sinus pain or congestion;
decreased sense of taste;
joint pain; or
pain, swelling, burning, or irritation around the IV needle.
Bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
chest pain or tightness in the chest
confusion
difficult or labored breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
nervousness
pounding in the ears
rapid weight gain

Drug Interactions of Iron /Ferric Carboxymaltose

Large doses of iron carboxymaltose 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 iron carboxymaltose. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of INFeD 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 iron dextran therapy because residual iron carboxy maltose 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 iron. Bone scans with 99m Tc-labeled bone-seeking agents, in the presence of high serum ferritin levels or following iron carboxymaltose, infusions have been reported to show the reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.
This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
ferrous fumarate
ferrous gluconate or
ferrous sulfate, and others.
Darbepoetin Alfa-(Minor) It is important that iron stores be replete before beginning therapy with either epoetin alfa or darbepoetin alfa due to increased iron utilization. Inadequate iron stores will interfere with the therapeutic response to these agents (e.g., red blood cell production).
Deferasirox- (Major) Deferasirox chelates iron and is indicated as a treatment of iron toxicity or overdose. It would be illogical for a patient to receive both iron supplementation and deferasirox simultaneously.
Deferiprone –(Major) Deferiprone chelates iron.
Deferoxamine -(Severe) Deferoxamine chelates iron from ferritin or hemosiderin. A stable complex is formed that prevents iron from entering into further chemical reactions.
Epoetin Alfa –(Minor) Inadequate iron stores will interfere with the therapeutic response to epoetin alfa (e.g., red blood cell production).
Ferric Citrate- (Major) Concurrent use of ferric citrate with other iron preparations (e.g., iron dextran; iron salts; iron sucrose, sucroferric oxyhydroxide; polysaccharide-iron complex; sodium ferric gluconate complex; iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may result in excessive elevations in iron stores.
Iron-(Severe) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory.
Methoxy polyethylene glycol-epoetin beta– (Minor) Iron stores should be replete before and during treatment with an ESA.

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Pregnancy & Lactation

FDA Pregnancy Category B

Pregnancy

Studies of ferric carboxymaltose use in pregnant women have not reported an association with ferric carboxymaltose and adverse developmental outcomes; however, available data cannot establish or exclude the absence of any drug-related risks during pregnancy because the studies were not designed to assess the risk of major birth defects. In animal studies, administration of ferric carboxymaltose during organogenesis caused adverse developmental outcomes, including malformations and increased implantation loss, at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area).

Lactation

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ferric carboxymaltose and any potential adverse effects on the breastfed infant from ferric carboxymaltose or the underlying maternal condition. Monitor breast-fed infants for gastrointestinal adverse effects (i.e., constipation, diarrhea) during exposure to ferric carboxymaltose. Ferric carboxymaltose is excreted into breast milk; however, the full potential exposure of iron to the nursing infant is unknown.