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INTRODUCTION
FERINJECT 500MG contains Ferric carboxymaltose which belongs to the group of medicines called Iron replacement medicines. It is used to treat iron deficiency anaemia (IDA) in adults and in children (above 14 years of age), who are unable to take iron supplements orally, have an intolerance to oral iron supplements, need a rapid iron supplement in the body, have non-dialysis dependent chronic kidney disease. Iron deficiency anaemia is a condition in which the body lacks enough amount of iron, which is essential for the production of red blood cells and transport of oxygen in the body.
Your doctor may advise you to take relevant tests to understand your existing condition. Before receiving FERINJECT 500MG inform your doctor if you are pregnant or planning to get pregnant or breast-feeding. FERINJECT 500MG is not recommended for use in children and adolescents (under 14 years of age) and it should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before receiving FERINJECT 500MG.
The most common side effects of receiving FERINJECT 500MG may include headache, dizziness, flushing, high blood pressure, nausea and injection or infusion site reactions. Consult your physician if any of the symptom worsens.
USES OF FERINJECT 500MG
- Treats iron deficiency anaemia
HOW FERINJECT 500MG WORKS
FERINJECT 500MG contains iron (III) hydroxide complexed with a carbohydrate polymer called carboxymaltose, which is capable of releasing iron. The iron released from the complex helps in the synthesis of haemoglobin and increases red blood cell count. As a result, it treats iron deficiency anaemia.
DIRECTIONS FOR USE
FERINJECT 500MG will be given to you only by a doctor or a nurse into a vein as an intravenous injection or infusion. Your physician will decide the correct dose and duration for you depending upon your age, body weight and severity of the condition.
SIDE EFFECTS OF FERINJECT 500MG
COMMON
- headache
- dizziness
- flushing
- high blood pressure
- nausea
- injection/infusion site reactions
- low levels of phosphorous in the blood
UNCOMMON
- numbness
- prickling or tingling sensation of the skin
- change in taste sensation
- increased heart rate
- low blood pressure
- difficulty in breathing
- vomiting
- indigestion
- stomach pain
- constipation
- diarrhoea
- itching
- redness of the skin
- skin rash
- muscle or joint pain
- back pain
- pain in the arms or the legs
- muscle spasms
- fever
- tiredness
- chest pain
- swelling of the hands and feet, and chills
RARE
- inflammation of the vein
- general feeling of discomfort
- anxiety
- fainting or feeling faint
- wheezing
- flatulence
- rapid swelling of the face, mouth, tongue or throat which may cause difficulty in breathing
- paleness and discoloration of the skin in other areas of the body than the injected site
Contact your doctor immediately if you experience any of the following side effects:
- symptoms of serious allergic reaction or kounis syndrome (such as rashes, itching, swelling of the face, lips, mouth, tongue, throat or body causing difficulty in breathing or wheezing and chest pain)
- severe or life-threatening allergic reactions called anaphylactic reactions which can be associated with heart, circulation problems (low blood pressure) and loss of consciousness
- sign of a decrease in blood phosphorus causing softening of bones (osteomalacia) symptoms include worsening of tiredness, muscle or bone pain (pain in arms or legs, joints or back) and may lead to fractures
- signs of high blood pressure (such as facial flushing, dizziness or nausea)
- skin irritation and brownish discolouration of the skin at the injected site
HOW TO MANAGE SIDE EFFECTS
Headache:
Take rest and relax. Drink plenty of fluids such as water. Apply a pain-relieving balm on the forehead if necessary. Consult your doctor if your headache does not improve.
Nausea or vomiting:
Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Stomach pain:
Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.
Diarrhoea:
Drink lot of fluids, such as water or fruit juices to keep yourself hydrated. Avoid eating high-fat or spicy foods. If the symptom does not improve, consult your doctor.
Constipation:
Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
FERINJECT 500MG should be used with caution in pregnant women only if considered clearly necessary. Inform your doctor if you are pregnant, think you may be pregnant, or planning to have a baby. Consult your doctor before receiving FERINJECT 500MG.
BREASTFEEDING
If you are breastfeeding, consult your doctor for advice before receiving FERINJECT 500MG. It is unlikely that FERINJECT 500MG represents a risk to the breast-fed child.
DRIVING AND USING MACHINES
FERINJECT 500MG is unlikely to impair the ability to drive or operate machines.
KIDNEY
FERINJECT 500MG should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving FERINJECT 500MG.
LIVER
FERINJECT 500MG should be used with caution in patients with liver disease. Consult your doctor before receiving FERINJECT 500MG.
ALLERGY
Do not receive FERINJECT 500MG if you are allergic to ferric carboxymaltose or any of the other ingredients of this medicine or if you have experienced serious allergic reactions to other injectable iron preparations.
LUNGS
FERINJECT 500MG should be used with caution in patients with severe asthma. Consult your doctor before receiving FERINJECT 500MG.
OTHERS
FERINJECT 500MG is not recommended for use if you have:
- anaemia not caused by iron deficiency
- iron overload (too much iron in your body) or disturbances in the utilisation of iron
Before receiving FERINJECT 500MG inform your doctor if you have:
- systemic lupus erythematosus
- rheumatoid arthritis
- eczema or other allergies
- an infection
- low levels of phosphate in the blood
- high blood pressure
Use in paediatrics:
FERINJECT 500MG is not recommended for use in children (under 14 years of age). Consult child’s doctor for advice to treat the condition.
Use in geriatrics:
FERINJECT 500MG should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before receiving FERINJECT 500MG.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving FERINJECT 500MG, inform your doctor if you are using or have recently taken any other medicines including prescription, non-prescription medicines and vitamins or herbal supplements.
- oral iron preparations such as ferrous ascorbate, ferrous sulphate, ferric citrate (used to prevent or treat low levels of iron in the body)
Overdosage:
FERINJECT 500MG will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms.
SYNOPSIS
| Drug | : | Ferric carboxymaltose |
| Pharmacological Category | : | Iron replacement medicines |
| Therapeutic Indication | : | Iron Deficiency Anemia (IDA) |
| Dosage Forms | : | Injection |
MORE INFORMATION
- Keep FERINJECT 500MG out of reach in children
- Store at room temperature
FAQs ABOUT FERINJECT 500MG
How does FERINJECT 500MG work?
FERINJECT 500MG contains iron (III) hydroxide complexed with a carbohydrate polymer called carboxymaltose, which is capable of releasing iron. The iron released from the complex helps in the synthesis of haemoglobin and increases red blood cell count. As a result, it treats iron deficiency anaemia.
Is FERINJECT 500MG safe to use in patients with kidney problems?
FERINJECT 500MG should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving FERINJECT 500MG.
Who should avoid receiving FERINJECT 500MG?
FERINJECT 500MG is not recommended for use in patients with evidence of iron overload or disturbances in the utilisation of iron, anaemia not attributed to iron deficiency (microcytic anaemia) and with known allergic to ferric carboxymaltose or serious allergic to other parenteral iron products.
Is FERINJECT 500MG safe to use in elderly patients?
FERINJECT 500MG should be used with caution in elderly patients (aged 65 years or above). Your doctor may monitor you carefully during administration and certain time after administration of FERINJECT 500MG. Consult your doctor before receiving FERINJECT 500MG.
Can FERINJECT 500MG be used during pregnancy?
FERINJECT 500MG should be used with caution in pregnant women only if clearly advised by your doctor. Inform your doctor if you are pregnant, think you may be pregnant, or planning to have a baby. Consult your doctor before receiving FERINJECT 500MG.
REFERENCES
1. KD. Tripathi. Haematinics and Erythropoietin. Essentials of medical pharmacology. Seventh edition. 2013. Page – 605.
2. Joao Ricardo Friedrischa and Rodolfo Delfini Cancadob. Intravenous ferric carboxymaltose for the treatment of iron deficiency anemia. NIH. National Library of Medicine, National Center for Biotechnology Information. PMC PubMed Central. October 2015. [Accessed on 1st July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678908/
3. American Regent, Inc. Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia. NIH. U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in February 2018] [Accessed on 1st July 2022] https://clinicaltrials.gov/ct2/show/NCT00703937
4. Vifor France. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 1st July 2022] https://www.medicines.org.uk/emc/files/pil.5910.pdf
5. Vifor (International) Inc. U.S. Food & Drug Administration. [Revised in April 2021] [Accessed on 1st July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565s014lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Ferritin
- Iron Serum
- Total Iron Binding Capacity
- Transferrin Saturation
- Complete blood count
PRODUCT DETAILS
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