Orofer FCM 1K Injection (Ferric Carboxymaltose 50mg)

INTRODUCTION

OROFER FCM contains Ferric carboxymaltose which belongs to the group of medicines called anti-anemic agents. It is an iron replacement medicine used in the treatment of iron deficiency anemia among adult patients who have intolerance or unsatisfactory response to oral iron or in adult patients who have non-dialysis dependent chronic kidney disease. Iron deficiency anemia is a condition in which the body lacks enough amount iron which is responsible for the formation of healthy red blood cells and oxygen transport in the body.

Ferric carboxymaltose 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 hemoglobin and red blood cells, leading to correction of iron-deficiency anemia. OROFER FCM should be given only when your doctor decides that your body needs iron very quickly to build up your iron stores.

The most common side effects of this medicine are injection site irritation, headache, dizziness, high blood pressure and nausea. Before taking this medicine, inform your doctor if you have hypophosphatemia, infection, allergic reactions or liver disease. It is highly contraindicated in patients having an iron-independent anemia or iron overload disorders. It is not recommended for use in children aged under 14 years. It should be used with caution in pregnant or breastfeeding women. Contact your doctor before taking.

USES OF OROFER FCM

Treats iron deficiency anemia in adult patients

HOW OROFER FCM WORKS

Iron is an important mineral ion responsible for the formation of new red blood cells and hemoglobin and transport of oxygen in the body. Lack of iron may lead to iron deficiency and impairment in the synthesis of red blood cells and hemoglobin and transport of oxygen in the body.

Systemic administration of ferric carboxymaltose effectively replenishes and restores iron in the body. It enhances the formation of hemoglobin and red blood cells and increases the supply of oxygen to the body, leading to correction of iron-deficiency anemia.

DIRECTIONS FOR USE

OROFER FCM will be given to you only by a doctor or nurse into the vein (intravenously) either as an injection or infusion. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF OROFER FCM

SERIOUS
Signs of Kounis syndrome (such as skin rash, itching, difficulty in breathing, swelling of the lips, tongue, throat or body, and chest pain)
Signs of hypophosphatemia (such as muscle or bone pain and worsening of tiredness)
COMMON
Injection site reactions (such as irritation)
Headache, dizziness
Flushing (feeling hot)
High blood pressure
Nausea
RARE
Inflammation of a vein
Feeling discomfort, anxious or faint
Flatulence
Rapid swelling of the face, mouth, tongue or throat which lead to difficulty in breathing and paleness

HOW TO MANAGE SIDE EFFECTS

Nausea:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

Flatulence:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If the symptoms get worse, contact your doctor straight away.

Headache:

Rest and drink plenty of fluids. Do not drink too much alcohol.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid traveling, driving or operating any tools or machines while you are feeling dizzy. If the symptom still persists, contact your doctor for advice.

WARNING & PRECAUTIONS

PREGNANCY
OROFER FCM should be used with caution in pregnant women. Consult your doctor before taking.

BREASTFEEDING
OROFER FCM should be used with caution in breastfeeding women. Consult your doctor before taking.

LIVER
OROFER FCM should be taken with caution in patients with severe liver disease. Consult your doctor for advice.

ALLERGY
Do not take this medicine if you are allergic to ferric carboxymaltose or other iron preparations.

LUNGS
OROFER FCM should be taken with caution in patients with asthma. Consult your doctor for advice.

OTHERS

Before taking this medicine, inform your doctor if you have:

A history of medicine allergy
Systemic lupus erythematosus (an allergic skin reaction)
Rheumatoid arthritis (joint pain)
Eczema or other allergies
An infection
Or had hypophosphatemia (low blood phosphate levels)

INTERACTIONS

Talk to your doctor, if you are taking,

Oral iron preparations (e.g. ferrous ascorbate, ferrous sulphate, ferric citrate)