Revofer 500mg Inj

REVOFER 500MG INJ by LUPIN LTD

Name

• Brand Name: REVOFER 500MG INJ
• Common Name: Ferric Carboxymaltose Injection

Composition

REVOFER 500MG INJ contains Ferric Carboxymaltose, which is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer. Each 10 ml vial contains Ferric Carboxymaltose equivalent to 500 mg of elemental iron.

Uses

REVOFER 500MG INJ is primarily used for the treatment of iron deficiency anemia in adult patients. It is particularly indicated for those who:

• Are intolerant to oral iron preparations or have had an unsatisfactory response to oral iron.
• Have non-dialysis dependent chronic kidney disease (CKD) and iron deficiency anemia.
• Require a rapid replenishment of their body's iron stores.
• Have heart failure with iron deficiency to improve exercise capacity.

Dosage and Administration

REVOFER 500MG INJ must be administered intravenously, either as an undiluted slow intravenous push or by infusion after dilution in sterile 0.9% sodium chloride injection.

• For patients weighing 50 kg or more: Two doses of 750 mg each, separated by at least 7 days, for a total cumulative dose not exceeding 1500 mg of iron per course.
• For patients weighing less than 50 kg: Two doses of 15 mg/kg body weight each, separated by at least 7 days, for a total cumulative dose not exceeding 1500 mg of iron per course.
• When administered as a slow intravenous push, the rate should be approximately 100 mg (2 mL) per minute.
• For infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, ensuring the concentration is not less than 2 mg iron/mL, and administer over at least 15 minutes.
• The maximum recommended cumulative dose is 1000 mg of iron per week.

Side Effects

Common side effects may include:

• Headache, dizziness, nausea, vomiting, abdominal pain, constipation.
• Hypertension (increased blood pressure), flushing.
• Decreased blood phosphorus (hypophosphatemia).
• Injection site reactions (pain, discoloration, extravasation, erythema).
• Pruritus, rash, urticaria, wheezing.
• Myalgia (muscle pain), back pain, arthralgia (joint pain), pyrexia (fever), fatigue.

Serious side effects, though less common, can include:

• Serious hypersensitivity reactions, including anaphylactic-type reactions, which can be life-threatening.
• Hypotension.

Precautions

• Hypersensitivity Reactions: Serious hypersensitivity reactions are possible. Patients should be monitored for at least 30 minutes after administration, and personnel/therapies for managing such reactions must be immediately available.
• Hypertension: Transient elevations in blood pressure may occur, typically resolving within 30 minutes. Patients should be monitored for signs and symptoms of hypertension.
• Extravasation: Avoid extravasation, as it can lead to long-lasting brown discoloration at the injection site.
• Iron Overload: Excessive dosages can lead to iron accumulation (hemosiderosis). Monitoring of iron parameters (serum ferritin and transferrin saturation) is recommended.
• Interactions: REVOFER can reduce the absorption of oral iron therapies; oral iron should not be started for at least 5 days after the last REVOFER injection.
• Contraindications: Not recommended for patients with known serious hypersensitivity to other parenteral iron products, anemia not attributed to iron deficiency, or evidence of iron overload.
• Specific Conditions: Use with caution in patients with liver problems, kidney disease, severe asthma, systemic lupus erythematosus, rheumatoid arthritis, eczema, or infections.
• Pregnancy and Lactation: A careful benefit/risk evaluation is required. Treatment is generally confined to the second and third trimester if the benefit outweighs the potential risk. Limited data suggest it's unlikely to pose a risk to breastfed infants.
• Pediatric Use: Not recommended for children under 14 years of age as safety and efficacy data are not established.

Storage

REVOFER 500MG INJ vials should be stored at a temperature not exceeding 30°C, protected from light and moisture. Do not freeze. Each vial is for single use only, and any unused portion should be discarded. Diluted solutions should be used within 72 hours when stored at room temperature, or within 24 hours if refrigerated, but only if diluted to a concentration of at least 2 mg iron/mL.

REVOFER 500MG INJ by LUPIN LTD: Frequently Asked Questions

What is REVOFER 500MG INJ used for?

REVOFER 500MG INJ is primarily used to treat iron deficiency anemia in adult patients. It is often prescribed for individuals who cannot tolerate oral iron therapy, for whom oral iron therapy is ineffective, or for those with chronic kidney disease (non-dialysis dependent) suffering from iron deficiency anemia. It can also be used for rapid replenishment of iron stores.

How does REVOFER 500MG INJ work?

REVOFER 500MG INJ contains ferric carboxymaltose, which acts as a source of iron. This iron is supplied directly into the bloodstream. It then dissociates into iron and carboxymaltose, with the iron being used by the body to produce hemoglobin. Hemoglobin is essential for red blood cells to transport oxygen throughout the body, thereby helping to manage iron deficiency anemia and improve oxygen levels.

What is the usual dosage of REVOFER 500MG INJ?

The dosage of REVOFER 500MG INJ is determined by your doctor based on your health condition, age, and body weight. For patients weighing 50 kg or more, it is typically given in two doses of 750 mg each, separated by at least 7 days, with a total cumulative dose not exceeding 1500 mg per course. For patients weighing less than 50 kg, each dose is 15 mg/kg body weight, also given in two doses separated by at least 7 days, not exceeding a total cumulative dose of 1500 mg per course. The medicine is administered intravenously (into a vein) either as a slow injection or an infusion by a healthcare professional.

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

Common side effects may include headache, nausea, vomiting, abdominal pain, dizziness, hypertension (high blood pressure), flushing, muscle pain (myalgia), back pain, joint pain (arthralgia), fever (pyrexia), fatigue, and reactions at the injection site (such as pain, redness, or discoloration). Serious hypersensitivity reactions, though rare, can occur and may include severe allergic reactions, low blood pressure, or loss of consciousness. You should consult your doctor if any side effects worsen or persist.

Is REVOFER 500MG INJ safe during pregnancy or breastfeeding?

During pregnancy, REVOFER 500MG INJ should be used with caution and only if clearly necessary, as there is limited data on its effects on human pregnancy. A careful benefit/risk evaluation by your doctor is required. For breastfeeding mothers, the active ingredient (ferric carboxymaltose) is excreted in human milk, but it is considered unlikely to pose a risk to the breastfed child. Always consult your doctor before using this medicine if you are pregnant or breastfeeding.

Can REVOFER 500MG INJ be taken with other medications?

REVOFER 500MG INJ can interact with other medications. Oral iron therapies, such as ferrous sulphate or ferrous fumarate, should not be started for at least 5 days after the last REVOFER Injection, as it can reduce their absorption and efficacy. It's crucial to inform your doctor about all medications, supplements, and herbal products you are currently taking or plan to take to avoid potential interactions.

What precautions should be taken with REVOFER 500MG INJ?

Several precautions should be observed. Patients with liver disease, acute or chronic infections, low phosphate levels, asthma, systemic lupus erythematosus, rheumatoid arthritis, or other allergies should use this medicine with caution. It is contraindicated if you have anemia not caused by iron deficiency, iron overload, or known serious allergies to ferric carboxymaltose or other parenteral iron products. Patients should be monitored for signs of hypersensitivity reactions during and after administration. Avoid extravasation (leakage outside the vein) as it can cause long-lasting skin discoloration.

What happens if a dose is missed?

Since REVOFER 500MG INJ is administered by a healthcare professional in a clinical setting, it is unlikely that a dose will be missed. However, if you miss a scheduled dose, inform your doctor or nurse immediately. They will advise on how to proceed.

How should REVOFER 500MG INJ be stored?

REVOFER 500MG INJ vials should be stored in a cool, dry place, typically between 20°C to 25°C (68°F to 77°F), or below 30°C. It should be protected from light and moisture and should not be frozen. Keep it out of reach of children. The product contains no preservatives and each vial is for single use only, with any unused portion to be discarded.