HyperHEP B® S/D

Product Overview:

• Brand Name: HyperHEP B® S/D
• Type: Hepatitis B Immune Globulin (Human), Solvent/Detergent Treated
• Form: Injectable solution, ≥220 IU/mL
• Manufacturer: Grifols Therapeutics Inc.

Indications and Clinical Use:

• Post-exposure Prophylaxis:
• Acute Exposure: Used for individuals exposed to hepatitis B virus (HBV) through needlesticks, mucous membrane contact, or oral ingestion involving HBsAg-positive materials.
• Perinatal Exposure: For infants born to HBsAg-positive mothers, to prevent HBV infection.
• Sexual Exposure: For sexual partners of HBsAg-positive individuals.
• Household Exposure: For infants under 12 months exposed to primary caregivers with acute HBV infection.
• Combination Therapy: Recommended to be used in conjunction with the hepatitis B vaccine for both short- and long-term protection.

Dosage and Administration:

• Acute Exposure to Blood Containing HBsAg: Administer 0.06 mL/kg intramuscularly as soon as possible after exposure, ideally within 48 hours.
• Perinatal Exposure: Administer 0.5 mL intramuscularly to the newborn within 12 hours of birth.
• Sexual Exposure: Administer a single dose of 0.06 mL/kg intramuscularly within 14 days of the last sexual contact.
• Household Exposure: Administer 0.5 mL intramuscularly for infants.

Contraindications:

• Hypersensitivity to any component of the product.
• Severe thrombocytopenia or coagulation disorders that contraindicate intramuscular injections unless benefits outweigh risks.

Warnings and Precautions:

• General: Not to be administered intravenously. Products made from human plasma may contain infectious agents. Discuss risks and benefits with patients before administering.
• Hypersensitivity: Caution in patients with a history of allergic reactions to immune globulin preparations. Epinephrine should be available.
• Special Populations:
• Pregnant Women: Administer only if clearly needed.
• Pediatrics: Safety and effectiveness in infants up to 12 months are established.

Adverse Reactions:

• Common Reactions: Local pain and tenderness at the injection site.
• Less Common Reactions: Urticaria, angioedema, and rare anaphylactic reactions.

Drug Interactions:

• Live Viral Vaccines: May interfere with live viral vaccines other than measles. Administer vaccines 3 months after HyperHEP B® S/D.
• Hepatitis B Vaccine: Can be administered concurrently but at different sites.

Storage and Stability:

• Store at 2-8°C. Do not freeze. Use before the expiration date. Once opened, discard any unused contents.

Mechanism of Action:

• Provides passive immunization by supplying antibodies against HBV, reducing the attack rate of hepatitis B following exposure.

Pharmacokinetics:

• Detectable passive antibody titers appear within 24 hours post-injection and persist for up to 21 days. The half-life ranges from 17.5 to 25 days.

Consumer Information:

• Usage: Prevents hepatitis B infection after exposure through blood, sexual contact, or perinatal transmission.
• Administration: Intramuscular injection by healthcare professionals.
• Storage: Store in the refrigerator, do not freeze, and discard any unused portions after opening.