Description

Rhophylac 300 is an anti-D immunoglobulin injection used to prevent Rh sensitization in Rh-negative pregnant women and individuals who have received incompatible Rh-positive blood transfusions.Key points about Rhophylac 300:

• Each pre-filled syringe contains 300 micrograms (1500 IU) of human anti-D immunoglobulin
• It can be administered intravenously or intramuscularly
• For Rh-incompatible pregnancies, the recommended dosage is two doses: one at 28-30 weeks gestation and another within 72 hours after delivery
• Rhophylac is made from human plasma using a manufacturing process called ChromaPlus which helps reduce the risk of viral transmission
• Common side effects include joint/muscle pain, headache, dizziness, weakness, itching, rash, nausea, and pain at the injection site
• Serious side effects like hemolytic anemia, blood clots, organ failure, and allergic reactions are possible

Rhophylac 300 is an essential medication for preventing complications in Rh-incompatible pregnancies and managing accidental Rh-positive blood exposures in Rh-negative individuals. However, patients should be closely monitored for potential adverse reactions.

Composition and Dosage

• Each pre-filled syringe contains 300 micrograms (1500 IU) of human anti-D immunoglobulin
• Can be administered intravenously or intramuscularly
• For Rh-incompatible pregnancies, the recommended dosage is two doses: one at 28-30 weeks gestation and another within 72 hours after delivery

Manufacturing Process

• Rhophylac is made from human plasma using a manufacturing process called ChromaPlus
• The ChromaPlus process helps reduce the risk of viral transmission

Indications and Use

• Used to prevent Rh sensitization in Rh-negative pregnant women and individuals who have received incompatible Rh-positive blood transfusions

Potential Side Effects

• Common side effects include joint/muscle pain, headache, dizziness, weakness, itching, rash, nausea, and pain at the injection site
• Serious side effects like hemolytic anemia, blood clots, organ failure, and allergic reactions are possible

Monitoring and Precautions

• Patients should be closely monitored for potential adverse reactions after receiving Rhophylac 300                                                                                                                                                                  Key Benefits of Rhophylac 300:
  1. Prevents Rh Sensitization: Rhophylac 300 is used to prevent Rh sensitization in Rh-negative pregnant women and individuals who have received incompatible Rh-positive blood transfusions.
  2. Effective in Pregnancy: It is administered during pregnancy to prevent the formation of antibodies against the Rh antigen in the fetus, ensuring the mother does not develop an immune response to the baby’s blood type.
  3. Treatment of Incompatible Transfusions: Rhophylac 300 is used to treat Rh-negative individuals who have received incompatible Rh-positive blood transfusions, helping to prevent the formation of antibodies against the Rh antigen.
  4. Reduced Risk of Hemolytic Reaction: The product is designed to reduce the risk of hemolytic reactions in patients who have received incompatible blood transfusions.

  Key Ingredients:

  1. Anti-D Immunoglobulin: The active ingredient in Rhophylac 300 is anti-D immunoglobulin, which is derived from human plasma and is used to prevent the formation of antibodies against the Rh antigen.
  2. Human Plasma: The product is manufactured using human plasma, which is processed to reduce the risk of viral transmission, including HIV, hepatitis B, and hepatitis C.

  key points about the mechanism of action of Rhophylac (anti-D immunoglobulin) are:Suppression of Rh Isoimmunization:

  • The exact mechanism is not completely known, but it is thought to involve the formation of Rh(D) immune globulin-red blood cell complexes that are preferentially removed by the reticuloendothelial system .
  • In clinical studies, both intravenous and intramuscular administration of Rhophylac after injection of Rh(D)-positive red blood cells resulted in rapid clearance of the Rh(D)-positive cells – on average, 99% were cleared within 12 hours with intravenous administration and 144 hours with intramuscular administration .

  Treatment of Immune Thrombocytopenic Purpura (ITP):

  • Rhophylac has been shown to increase platelet counts and reduce bleeding in Rh(D)-positive subjects with chronic ITP .
  • The proposed mechanism is that the Rh(D) immune globulin-red blood cell complexes are preferentially removed by the reticuloendothelial system, particularly the spleen, resulting in Fc receptor blockade and sparing of antibody-coated platelets .                                  The key points about the composition and structure of Rhophylac 300 are:Active Ingredient:
    • The active ingredient is human anti-D immunoglobulin, also known as Rho(D) Immune Globulin or Rh factor.
    • Each pre-filled syringe contains 300 micrograms (1500 IU) of the anti-D immunoglobulin.

    Immunoglobulin Structure:

    • Immunoglobulins like the anti-D antibody in Rhophylac have a characteristic Y-shaped quaternary structure composed of heavy and light polypeptide chains.
    • The distribution of IgG subclasses in Rhophylac is approximately: IgG1 84.1%, IgG2 7.6%, IgG3 8.1%, and IgG4 1.0%.

    Formulation:

    • Rhophylac is a sterile solution containing the anti-D immunoglobulin, as well as human albumin as a stabilizer and other plasma proteins.
    • The solution is provided in a 2 mL pre-filled glass syringe for intramuscular or intravenous administration.

    However, the specific molecular details of the anti-D immunoglobulin structure are not disclosed in the available information. As a complex biological product, Rhophylac does not have a defined small-molecule chemical structure that can be easily represented. The focus is on its composition, manufacturing process, and clinical use rather than the detailed molecular structure of the active ingredient.                                                             

    Dosage

    • Each pre-filled syringe contains 300 micrograms (1500 IU) of human anti-D immunoglobulin in a 2 mL solution.
    • For Rh-incompatible pregnancies, the recommended dosage is two doses: one at 28-30 weeks gestation and another within 72 hours after delivery.
    • The dose must be increased if the patient is exposed to >15 mL of Rh0(D)-positive red blood cells.
    • For treatment of immune thrombocytopenic purpura (ITP), the recommended dose is 250 IU (50 mcg) per kg body weight, administered intravenously at a rate of 2 mL per 15 to 60 seconds.

    Storage

    • Do not freeze Rhophylac.
    • Store at 2 to 8°C (36 to 46°F) for a shelf life of 36 months from the date of manufacture, as indicated by the expiration date printed on the outer carton and syringe label.
    • Keep Rhophylac in its original carton to protect it from light.
    • Bring Rhophylac to room temperature before use.