|Company:||Incepta Pharmaceuticals Ltd.|
Maltofer is an iron replacement medicine. It is used to treat a type of anemia where you have fewer amount of red blood cells due to insufficient iron in your body (iron-deficiency anemia). Iron is needed to produce the red blood cells that carry oxygen around your body. Maltofer is given by injection or infusion (saline drip) into a vein by your doctor or nurse. You will be watched carefully to make sure you do not have an allergic reaction. It is usually given in two doses, seven days apart. Your doctor will decide how much and how often you may need injections to improve your anemia. Eating a well-balanced diet that has enough iron, vitamins, and minerals can help to replenish your iron reserves. Good sources of iron include meat, eggs, raisins, broccoli, and lentils.
The most common side effects include vomiting, headache, dizziness, feeling hot (flushing) or sick, high blood pressure, and pain or irritation at the site of injection. Most of these usually go away within a short time of the injection. If you are bothered by them or they go on for longer, talk to your doctor or nurse. You should not have this medicine if your anemia is not caused by a lack of iron. Before taking it, tell your doctor if you have rheumatoid arthritis, asthma or other allergies, high blood pressure, or liver problems. This may affect your treatment. It is not known whether this medicine is safe for use if you are pregnant or breastfeeding so please take advice from your doctor. You will have tests to check your blood cells and iron levels, monitor your progress and check for side effects. It may be advisable to limit alcohol during treatment.
Uses of Maltofer
- Iron deficiency anemia
Side effects of Maltofer
- Injection site reactions (pain, swelling, redness)
- Dark colored stool
How to use Maltofer
Your doctor or nurse will give you this medicine. Kindly do not self-administer.
How Maltofer works
Maltofer is an anti-anemic medication. It replenishes the iron stores in your body. Iron is vital for the formation of new red blood cells and hemoglobin, a substance that gives these cells the ability to transport oxygen.
What if you forget to take Maltofer?
If you miss a dose of Maltofer, please consult your doctor.
- Maltofer is used for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.
- Your doctor or nurse will administer it by injection. You will be observed for at least 30 minutes after each injection as it may cause an allergic reaction.
- Your blood pressure and blood iron levels will be regularly monitored during treatment with this medication.
- Inform your doctor if you are taking any iron-containing products by mouth.
- Do not consume alcohol when on treatment with this medicine as it may worsen its side effects.
- It may cause your stools to become black or dark in color. This is normal and harmless.
Iron deficiency anemia
IV Preparation For IV infusion, dilute in up to 250 mL 0.9% NaCl; resulting concentration should be >2 mg/mL IV Administration IV push: May administer undiluted at a rate of 100 mg/minute IV infusion: Dilute dose in up to 250 mL 0.9% NaCl and infuse over at least 15 minutes
Injection Iron-deficiency Anemia Indicated for treatment of iron deficiency anemia (IDA) in adults who have an intolerance or unsatisfactory response to oral iron; also indicated for IDA in adults with nondialysis dependent chronic kidney disease >50 kg: 750 mg IV once, follow 7 days later with second 750 mg dose; not to exceed the cumulative dose of 1500 mg per course <50 kg: 15 mg/kg IV once, follow 7 days later with second dose; not to exceed 1500 cumulative dose per course
Safety and efficacy not established
Hypersensitivity to any of its components.
Mode of Action
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulfs FCM from blood and controls iron release. Transferrin saturates and, Iron into the liver, spleen, and Bone marrow.
Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.
Other severe adverse reactions potentially associated with hypersensitivity which included, but are 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 were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration. Lactation Clinical studies showed that the transfer of iron from Ferric Carboxymaltose to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that Ferric Carboxymaltose represents a risk to the breast-fed child.
1-10% Nausea (7.2%), Hypertension (3.8%), Flushing (3.6%), Decreased blood phosphorus (2.1%), Dizziness (2%), Vomiting (1.7%), Pruritus (1.5%), Rash (1.5%), Urticaria (1.5%), Wheezing (1.5%), Injection site discoloration (1.4%), Headache (1.2%), Increased alanine aminotransferase (1.1%), Dysgeusia (1.1%), Hypotension 1%) <1% Constipation (0.5%), Serious anaphylactic/anaphylactoid reactions (0.1%)
Pregnancy Category Note
Pregnancy Studies on use in pregnant women have not reported adverse developmental outcomes; however, these studies cannot establish or exclude absence of any drug-related risk during pregnancy because studies were not designed to assess for risk of major birth defects; there are risks to mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight Lactation Available published data on use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk; however, the data do not inform the full potential exposure of iron for breastfed infant; among breastfed infants, there were no adverse events reported that were considered related to ferric carboxymaltose exposure through breastmilk; there is no information on effects of ferric carboxymaltose on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy in addition to any potential adverse effects on breastfed child from drug or from underlying maternal condition