Ferinject 500mg Inj

FERINJECT 500MG INJ

Name

• Brand Name: FERINJECT 500MG INJ.
• Common Name: Ferric Carboxymaltose Injection.

Composition

• Active Ingredient: Ferric Carboxymaltose (50 mg of iron per mL).
• Other Ingredients: Sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection. It also contains sodium, which should be considered for patients on a controlled sodium diet.

Uses

FERINJECT is an intravenous iron preparation used for the treatment of iron deficiency. It is prescribed when:

• Oral iron preparations are ineffective or cannot be used.
• There is a clinical need to deliver iron rapidly.
• It helps to replenish body iron stores and remedy anemia, a reduced level of hemoglobin due to iron deficiency.
• It is also used in patients with chronic kidney disease or malabsorption.

Dosage and Administration

FERINJECT is administered intravenously (IV) by a doctor or nurse. The dosage is determined by a healthcare professional based on the patient's iron needs, body weight, and hemoglobin levels.

• Routes of Administration: Can be given undiluted by injection, diluted by infusion, or during a hemodialysis session.
• Intravenous Injection: Up to 1000 mg of iron (20 mL of Ferric Carboxymaltose) can be given once a week directly into the vein. For doses greater than 200 mg and up to 500 mg, administer at a rate of 100 mg iron/minute. For doses greater than 500 mg and up to 1000 mg, administer over 15 minutes.
• Intravenous Infusion: Up to 1000 mg of iron (20 mL of Ferric Carboxymaltose) can be given once a week. The solution is diluted with sodium chloride solution, typically to a volume of up to 250 mL, and appears as a brown solution. The concentration should not be less than 2 mg iron/mL for stability reasons.
• Maximum Dose: The maximum single dose is 20 mg iron/kg body weight, not exceeding 1000 mg of iron. The maximum recommended cumulative dose is 1000 mg of iron per week.
• Special Populations:
  • Children (1-13 years): Administered in two IV doses of 15 mg iron (0.3 mL) per kg body weight, with at least a 7-day interval. Maximum single dose not to exceed 750 mg iron, and maximum cumulative dose not to exceed 1500 mg iron. FERINJECT is not recommended for children under 1 year of age.
  • Hemodialysis Patients: A single maximum daily dose of 200 mg iron should not be exceeded.
• Patients are typically observed for at least 30 minutes after each administration due to the risk of allergic reactions.

Side Effects

• Common Side Effects: Headache, dizziness, high blood pressure (which may be temporary), flushing, nausea, injection/infusion site reactions (pain, swelling, redness), and low blood phosphate levels. Dark colored stool may also occur.
• Uncommon Side Effects: Allergic reaction, tingling or numbness, fast heart rate, low blood pressure, difficulty breathing, taste disturbance, vomiting, indigestion, wind, stomach pain, constipation, diarrhea, itchiness, hives, skin redness, rash, muscle pain, muscle spasm, back pain, joint pain, pain in extremity, fever, fatigue, chest pain, swelling of hands, ankles or feet, and chills. Long-lasting brown discoloration of the skin may occur due to leakage at the injection site.
• Serious Side Effects: Severe allergic reactions (anaphylactoid reactions), which can include chest pain, breathing difficulty, swelling, lightheadedness, fast heartbeat, and sweating, can be life-threatening. Rarely, influenza-like illness, hypophosphatemic osteomalacia (soft bones due to low blood phosphate), and skin discoloration distant from the injection site have been reported.

Precautions

• Allergic Reactions: Intravenous iron preparations can cause severe hypersensitivity reactions, including anaphylaxis. Facilities for cardiopulmonary resuscitation must be available. Patients should be monitored for allergic reactions for at least 30 minutes post-administration.
• Contraindications: Do not use if allergic to ferric carboxymaltose or other ingredients, if anemia is not caused by iron deficiency, or if there is iron overload or disturbances in iron utilization.
• Pregnancy and Breastfeeding: Limited data exist for use in pregnancy before 16 weeks' gestation. Oral iron is generally preferred during the first trimester. FERINJECT should only be used in pregnancy if the benefit outweighs the risk. It is considered safe during breastfeeding.
• Medical Conditions: Use with caution in patients with infections, asthma, eczemas, allergies, liver disorders, hypertension, rheumatoid arthritis, or systemic lupus erythematosus. In patients with liver disorders, iron status should be monitored to avoid iron overload.
• Drug Interactions: Oral iron preparations will be less effective if given concurrently with FERINJECT.
• Extravasation: Avoid leakage at the injection site as it can cause long-lasting brown skin discoloration and irritation.
• Dilution: Must only be mixed with sterile 0.9% sodium chloride solution. No other solutions or therapeutic agents should be used to avoid precipitation or interaction.
• Children: Not recommended for children under 1 year of age.

Storage

• Store in the original package.
• Do not store above 30°C (some sources say below 30°C or between 20°C to 25°C).
• Do not refrigerate or freeze.
• Once a vial has been opened, it should be given immediately.
• After dilution with sodium chloride solution, the diluted solution should be given as soon as possible. If storage is necessary, hold at 2-8°C for not more than 12 hours.
• Protect from light.
• Keep out of the reach and sight of children.
• Each vial is for single use only, and any unused portion should be discarded.

FERINJECT 500MG INJ, which contains ferric carboxymaltose, is an intravenous iron preparation used to treat iron deficiency when oral iron supplements are ineffective or cannot be used, or when there is a clinical need to rapidly deliver iron. It helps to replenish the body's iron stores and alleviate iron deficiency anemia.

Here are some frequently asked questions about FERINJECT 500MG INJ:

What is FERINJECT 500MG INJ used for?

FERINJECT is used for the treatment of iron deficiency in adults, adolescents aged 14 years and older, and children aged 1 to 13 years with iron deficiency anemia. It is specifically indicated when oral iron preparations are ineffective, cannot be used, or when there is a rapid need for iron delivery. This includes conditions like chronic kidney disease or inflammatory bowel disease.

How does FERINJECT 500MG INJ work?

FERINJECT contains iron in the form of ferric carboxymaltose, an iron carbohydrate compound. This complex is designed to provide usable iron in a controlled manner to the body's iron transport and storage proteins (transferrin and ferritin). Iron is crucial for the production of hemoglobin in red blood cells, which carry oxygen throughout the body. By replenishing iron stores, FERINJECT helps to increase red blood cell production, improve oxygen supply to tissues, and reduce symptoms like fatigue and weakness.

What is the usual dosage of FERINJECT 500MG INJ?

The dosage of FERINJECT is determined by your doctor based on your body weight and hemoglobin levels, as confirmed by laboratory tests. It is administered intravenously either as an undiluted injection, diluted infusion, or during hemodialysis. For adults and adolescents aged 14 years and older, a single administration should not exceed 15 mg iron/kg body weight, with a maximum of 1000 mg of iron per week. Doses for patients weighing 50 kg or more typically involve two doses of 750 mg separated by at least 7 days, up to a cumulative dose of 1500 mg per course. For those under 50 kg, each dose is 15 mg/kg body weight, also given in two doses at least 7 days apart, not exceeding 1500 mg per course. Your doctor will monitor your iron parameters and may re-assess after 4 weeks to determine if more injections are needed.

What are the possible side effects of FERINJECT 500MG INJ?

Common side effects include headache, dizziness, high blood pressure, flushing, nausea, and reactions at the injection or infusion site. Other uncommon side effects can include allergic reactions, tingling or numbness, fast heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, abdominal pain, diarrhea, itching, hives, rash, muscle pain, back pain, joint pain, fever, and fatigue. Serious but rare side effects include severe allergic reactions (anaphylactoid reactions) which can be life-threatening and may include chest pain. Long-lasting brown discoloration of the skin can occur if the medication leaks at the injection site.

Is FERINJECT 500MG INJ safe during pregnancy or breastfeeding?

A careful risk/benefit evaluation is required before using FERINJECT during pregnancy, and it should not be used unless clearly necessary. There is no efficacy or safety data for use before 16 weeks' gestation, and oral iron is often preferred in the first trimester. If iron treatment is needed in pregnancy, FERINJECT should only be used if the benefit outweighs the risk, typically confined to the second and third trimesters. Fetal bradycardia (slow heartbeat in the unborn baby) can occur following parenteral iron administration, often due to a hypersensitivity reaction in the mother. During breastfeeding, FERINJECT is considered safe, as clinical studies show negligible transfer of iron into human milk.

Can FERINJECT 500MG INJ be taken with other medications?

If FERINJECT is given concurrently with oral iron preparations, the oral preparations will be less effective. Therefore, oral iron therapy should not be started for at least 5 days after the last administration of FERINJECT. It's important to inform your doctor about all other medications you are taking, including over-the-counter medicines.

What precautions should be taken with FERINJECT 500MG INJ?

You should inform your doctor if you have a history of medicine allergies, systemic lupus erythematosus, rheumatoid arthritis, severe asthma, eczema, other allergies, an infection, or liver disorders. Intravenous iron preparations can cause severe allergic reactions, and your doctor or nurse will observe you for at least 30 minutes after each administration. Facilities for treating anaphylaxis must be immediately available. Caution should also be exercised to avoid leakage of the drug at the injection site, which can cause long-lasting brown skin discoloration. Patients with liver dysfunction or those with a history of low blood phosphate levels should be carefully monitored.

What happens if a dose of FERINJECT 500MG INJ is missed?

FERINJECT is administered by a healthcare professional, so missed doses are unlikely. Your doctor will determine the appropriate dosing schedule and duration of treatment. If you have concerns about a missed dose, contact your healthcare provider.

How should FERINJECT 500MG INJ be stored?

FERINJECT should be stored in its original packaging at a temperature not exceeding 30°C to protect it from light. It should not be refrigerated or frozen. Once a vial is opened, it should be used immediately. If diluted with sodium chloride solution, the diluted solution should be used as soon as possible, or stored at 2-8°C for no more than 12 hours. Typically, FERINJECT will be stored by your doctor or the hospital.