Description:
Hepatect is a brand of Hepatitis B Immunoglobulin (HBIG) used for post-exposure prophylaxis to prevent Hepatitis B virus (HBV) infection. It contains immunoglobulins (antibodies) from human plasma that are specifically directed against the Hepatitis B surface antigen (HBsAg). It is typically administered to individuals who have been exposed to the Hepatitis B virus, such as after needlestick injuries, or for newborns born to mothers with Hepatitis B.

Prescription:

• Prescription required. 

Dosage:

• Post-exposure Prophylaxis:
  • Adults and Children: The typical dose is 0.06 mL/kg body weight. It should be administered as soon as possible after exposure, ideally within 24 hours.
  • For neonates born to mothers with Hepatitis B, the dose is usually 0.5 mL, administered within 12 hours after birth.
• Timing: Hepatitis B Immunoglobulin is usually administered in conjunction with the first dose of the Hepatitis B vaccine (HBV).

Therapeutic Category:

• Immunoglobulin / Post-exposure Prophylaxis for Hepatitis B

Active Ingredients/Composition:

• Human Hepatitis B Immunoglobulin: Contains antibodies derived from human plasma that specifically target and neutralize the Hepatitis B virus.

Variant:

• Hepatect (Hepatitis B Immunoglobulin) is available in a variety of formulations, including vials for injection.

Consume Type:

• Injection: Administered as an intramuscular (IM) injection, typically in the gluteal muscle or as instructed by a healthcare professional.

Directions/Usage:

• Post-exposure prophylaxis: The dose should be administered as soon as possible after a potential exposure to Hepatitis B. The vaccine and immunoglobulin are typically administered together.
• For infants born to Hepatitis B-infected mothers: The first dose of immunoglobulin is administered shortly after birth, followed by a vaccination schedule as recommended by healthcare providers.

Common Side Effects:

• Pain, redness, or swelling at the injection site
• Fever
• Headache
• Fatigue
• Allergic reactions (rare), such as rash, swelling, or difficulty breathing
• Rarely, more severe reactions such as anaphylaxis (severe allergic reaction)

Package Type:

• Available in multi-dose vials for healthcare use, typically containing 1, 5, or 10 mL of the immunoglobulin solution.

Storage Advice:

• Store at 2°C to 8°C (refrigerated).
• Do not freeze.
• Protect from light.

Safety Advice:

• Administer only under the supervision of a healthcare professional.
• Contraindicated for individuals with known hypersensitivity to any component of the immunoglobulin.
• Caution in individuals with a history of immune system disorders.
• Use during pregnancy should be determined by a healthcare provider, as it is considered safe when used appropriately.
• Monitor for signs of allergic reactions, especially after the first dose.

Product Substitutes:

• H-BIG (Hepatitis B Immunoglobulin): Other brands of Hepatitis B immunoglobulin.
• HyperHEP B S/D: Another Hepatitis B immunoglobulin product.

Manufacturer/Marketer:

• Biocryst Pharmaceuticals

Country of Origin:

• United States