INTRODUCTION
LARINJECT 50MG 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 LARINJECT 50MG inform your doctor if you are pregnant or planning to get pregnant or breast-feeding. LARINJECT 50MG 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 LARINJECT 50MG.
The most common side effects of receiving LARINJECT 50MG 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 LARINJECT 50MG
Treats iron deficiency anaemia
HOW LARINJECT 50MG WORKS
LARINJECT 50MG 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
LARINJECT 50MG 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 LARINJECT 50MG
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
LARINJECT 50MG 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 LARINJECT 50MG.
BREASTFEEDING
If you are breastfeeding, consult your doctor for advice before receiving LARINJECT 50MG. It is unlikely that LARINJECT 50MG represents a risk to the breast-fed child.
DRIVING AND USING MACHINES
LARINJECT 50MG is unlikely to impair the ability to drive or operate machines.
KIDNEY
LARINJECT 50MG should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving LARINJECT 50MG.
LIVER
LARINJECT 50MG should be used with caution in patients with liver disease. Consult your doctor before receiving LARINJECT 50MG.
ALLERGY
Do not receive LARINJECT 50MG 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
LARINJECT 50MG should be used with caution in patients with severe asthma. Consult your doctor before receiving LARINJECT 50MG.
OTHERS
LARINJECT 50MG 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 LARINJECT 50MG 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:
LARINJECT 50MG 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:
LARINJECT 50MG should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before receiving LARINJECT 50MG.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving LARINJECT 50MG, 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:
LARINJECT 50MG 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 LARINJECT 50MG out of reach in children
Store at room temperature
FAQs ABOUT LARINJECT 50MG
How does LARINJECT 50MG work?
LARINJECT 50MG 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 LARINJECT 50MG safe to use in patients with kidney problems?
LARINJECT 50MG should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving LARINJECT 50MG.
Who should avoid receiving LARINJECT 50MG?
LARINJECT 50MG 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 LARINJECT 50MG safe to use in elderly patients?
LARINJECT 50MG 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 LARINJECT 50MG. Consult your doctor before receiving LARINJECT 50MG.
Can LARINJECT 50MG be used during pregnancy?
LARINJECT 50MG 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 LARINJECT 50MG.
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
Country Of Origin
India
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