OROFER FCM INJ

Product Description

OROFER FCM 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 OROFER FCM inform your doctor if you are pregnant or planning to get pregnant or breast-feeding. OROFER FCM 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 OROFER FCM.

The most common side effects of receiving OROFER FCM 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 OROFER FCM

Treats iron deficiency anaemia   

HOW OROFER FCM WORKS

OROFER FCM 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

OROFER FCM 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 OROFER FCM

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 EFFECT

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

OROFER FCM 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 OROFER FCM.      

BREASTFEEDING

If you are breastfeeding, consult your doctor for advice before receiving OROFER FCM. It is unlikely that OROFER FCM represents a risk to the breast-fed child.   

DRIVING AND USING MACHINES

OROFER FCM is unlikely to impair the ability to drive or operate machines.

KIDNEY

OROFER FCM should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving OROFER FCM.  

LIVER

OROFER FCM should be used with caution in patients with liver disease. Consult your doctor before receiving OROFER FCM.                     

ALLERGY

Do not receive OROFER FCM 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

OROFER FCM should be used with caution in patients with severe asthma. Consult your doctor before receiving OROFER FCM.

OTHERS

OROFER FCM 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 OROFER FCM 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:

OROFER FCM 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:

OROFER FCM should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before receiving OROFER FCM.