Description

Rhophylac 300 Injection (Anti-D Immunoglobulin) – Uses, Dosage & Benefits

Rhophylac 300 is an anti-D immunoglobulin injection used to prevent Rh sensitization in Rh-negative pregnant women and in individuals who have received Rh-positive blood transfusions. It plays a vital role in avoiding complications such as hemolytic disease of the newborn and adverse transfusion reactions.

Manufactured using human plasma and purified through the ChromaPlus process, Rhophylac ensures safety with a reduced risk of viral transmission.

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Key Features of Rhophylac 300

• Strength & Formulation: Each prefilled syringe contains 300 mcg (1500 IU) of anti-D immunoglobulin in a sterile 2 mL solution.

• Administration Routes: Can be given intravenously (IV) or intramuscularly (IM).

• Pregnancy Protection: Two standard doses are recommended – one at 28–30 weeks of gestation and another within 72 hours after delivery.

• Additional Protection: Higher doses may be required if exposed to >15 mL of Rh(D)-positive red blood cells.

• ITP Treatment: For immune thrombocytopenic purpura (ITP), dosage is 250 IU (50 mcg) per kg body weight, administered IV.

• Storage: Keep refrigerated at 2–8°C (do not freeze). Shelf life up to 36 months. Must be kept in original carton to protect from light.

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How Rhophylac Works (Mechanism of Action)

Rhophylac contains human anti-D immunoglobulin (IgG) that helps prevent the immune system from producing antibodies against Rh-positive blood cells.

• In Pregnancy: It prevents the mother’s immune system from attacking fetal Rh-positive red blood cells, lowering the risk of hemolytic disease in newborns.

• In Transfusions: Prevents antibody formation in Rh-negative individuals exposed to Rh-positive blood.

• In ITP: Works by binding to red blood cells, which are cleared by the spleen, sparing platelets from destruction and raising platelet counts.

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Key Benefits of Rhophylac 300

• ✅ Prevents Rh Sensitization during pregnancy.

• ✅ Reduces risk of hemolytic disease of the newborn (HDN).

• ✅ Effective in Rh-incompatible transfusions.

• ✅ Helps manage immune thrombocytopenic purpura (ITP) by raising platelet counts.

• ✅ Manufactured with safety processes to minimize viral transmission risk.

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Composition & Structure

• Active Ingredient: Human Anti-D Immunoglobulin (Rho(D) immune globulin).

• Concentration: 300 mcg (1500 IU) per syringe.

• IgG Subclass Distribution: IgG1 (84.1%), IgG2 (7.6%), IgG3 (8.1%), IgG4 (1.0%).

• Formulation Additives: Human albumin and other plasma proteins for stability.

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Possible Side Effects

Like all biologic medicines, Rhophylac may cause side effects:

Common Side Effects:

• Muscle/joint pain

• Headache & dizziness

• Weakness, nausea

• Itching, rash

• Pain at injection site

Serious Side Effects (rare):

• Hemolytic anemia

• Blood clots

• Organ failure

• Severe allergic reactions (anaphylaxis)

⚠️ Patients should be closely monitored after injection.

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Storage Instructions

• Store at 2–8°C (36–46°F).

• Do not freeze.

• Shelf life: 36 months from date of manufacture.

• Keep away from sunlight in original packaging.

• Allow to reach room temperature before use.