Manufacturer: Emcure Pharmaceuticals Ltd
Salt Composition : Ferric Carboxymaltose(50mg/ml)
Orofer FCM 1K Injection 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, 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.
Orofer FCM 1K Injection 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.
Ferric carboxymaltose injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.
Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them
Common side effects of Orofer FCM
Vomiting
Nausea
Dark colored stool
Headache
Dizziness
High blood pressure
Injection site reactions (pain, swelling, redness)
If you are suffering from any of the following diseases, you should not take Ferric Carboxymaltose unless your doctor advises you to do so -
Liver Disease
Allergy
Orofer FCM 1K Injection may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
It is not known whether it is safe to consume alcohol with Orofer FCM 1K Injection. Please consult your doctor.
Orofer FCM 1K Injection is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.
Use with caution
Below 9years: Contraindicated
Ferric carboxymaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in patients ≥1 year of age who have an intolerance to, or unsatisfactory response from, oral iron therapy. It is also indicated in adult patients who have non-dialysis-dependent chronic kidney disease.
FERRIC CARBOXYMALTOSE may have interactions with iron storage or absorption disease, high blood pressure, and hypophosphatemia.
Kindly do not self administer.
Store below 25°C
If you miss a dose of Orofer FCM 1K Injection, please consult your doctor.
Consult a doctor before taking any medicines.
Orofer FCM 1K Injection 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 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.
Your doctor or nurse will give you this medicine. Kindly do not self administer.
Q. What precautions are required while administering Orofer FCM 1K Injection?
Orofer FCM 1K Injection should be administered by staff that is trained in dealing with serious allergic reactions (anaphylactic reaction). Orofer FCM 1K Injection can be administered as an undiluted injection, directly into the vein or via a dialyzer if the patient is on dialysis. It can also be diluted with sodium chloride and given as infusion directly into the vein. The patient should be monitored for at least 30 minutes after each injection. Also, the injection should not be given below the skin (subcutaneous route) or in the muscle (intramuscular route).
Q. How should Orofer FCM 1K Injection vials be stored before use?
Orofer FCM 1K Injection vials should be stored at 20°C to 25°C (68°F to 77°F). Remember, these should not be freezed. The temperature should not deviate more than 15°C to 30°C (59°F to 86°F).
Q. How often can Orofer FCM 1K Injection be re-injected?
Usually, two doses of this medicine are given 7 days apart. The hemoglobin is then assessed at least 4 weeks after the final injection to allow time for the RBCs to form. If the reports still show deficiency of iron, it can be re-administered depending on individual need.
Q. Can Orofer FCM 1K Injection cause an increase in blood pressure?
Yes, Orofer FCM 1K Injection may cause a temporary increase in blood pressure accompanied with facial flushing, dizziness, and nausea. This may occur immediately after you take the medicine and generally disappears within 30 minutes.
Q. What should be done if leakage of Orofer FCM 1K Injection occurs?
Incorrect administration of Orofer FCM 1K Injection may cause leakage of the medicine at the administration site. The administration must be stopped immediately if there is some leakage. The leakage may cause skin irritation and long-lasting brown discoloration of skin at the administration site.
Q. Is Orofer FCM 1K Injection safe in pregnancy?
There is limited data on the use of Orofer FCM 1K Injection in pregnancy. It is important to tell your doctor if you are pregnant or are planning to have a baby. Consult your doctor if you become pregnant during treatment with Orofer FCM 1K Injection. Your doctor will decide whether you need to continue treatment or discontinue it.
