PREHEVBRIO™

Product Overview:

• Brand Name: PREHEVBRIO™
• Type: 3-antigen Hepatitis B Vaccine (recombinant)
• Form: Suspension for injection
• Dosage Form/Strength: Each 1.0 mL dose contains 10 micrograms of Hepatitis B surface antigens (S [83%], pre-S2 [11%], and pre-S1 [6%]) adsorbed on 500 micrograms of aluminum hydroxide.
• Manufacturer: VBI Vaccines Inc.

Indications and Clinical Use:

• Indication: Active immunization against infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. It may also prevent hepatitis D.
• Pediatrics: No data available for individuals under 18 years; not authorized for pediatric use.
• Geriatrics: Studied in individuals aged 65 and older, with no dose adjustments required.

Dosage and Administration:

• Standard Schedule: Three doses administered intramuscularly. First dose at an elected date, second dose 1 month after the first dose, and third dose 6 months after the first dose.
• Administration: Intramuscular injection into the deltoid region. Injection into the gluteal region should be avoided. Use under aseptic conditions, shake well before use, and inspect visually for particulates or discoloration.

Contraindications:

• Hypersensitivity to any component of the vaccine or severe allergic reaction after a previous dose of any hepatitis B antigen-containing vaccine.

Warnings and Precautions:

• Vaccination should be postponed in individuals with acute severe febrile illness.
• Syncope (fainting) can occur; appropriate measures should be in place.
• Individuals with chronic liver disease, HIV infection, or hepatitis C should not be precluded from vaccination.
• Patients with renal impairment, especially those on hemodialysis, should ensure a protective antibody level is maintained.
• Use in pregnant and breastfeeding women only if the benefits outweigh potential risks. No data on fertility impacts.

Adverse Reactions:

• Common Adverse Reactions: Pain (72.2%), tenderness (71.2%), local pruritus (12.2%), myalgia (41.7%), fatigue (37.5%), headache (36.3%).
• Less Common Adverse Reactions: Injection site bruising, dizziness/vertigo, abdominal pain, rash.
• Clinical Trial Adverse Reactions: Higher rates of local reactions like pain and tenderness compared to Engerix-B. Systemic reactions include myalgia, fatigue, headache, diarrhea, nausea, and fever.

Drug Interactions:

• No interaction studies have been performed.
• If concurrent administration with immune globulin or other vaccines is required, they should be given with different syringes and at separate injection sites.

Clinical Trials and Immunogenicity:

• Study Sci-B-Vac-001: Showed higher seroprotection rates in adults aged 18+ compared to Engerix-B.
• Study Sci-B-Vac-002: Demonstrated non-inferiority of PREHEVBRIO to Engerix-B based on seroprotection rates in adults aged 18-45 years.

Storage and Stability:

• Store in a refrigerator at 2°C to 8°C. Protect from light and do not freeze. Use before the expiration date on the vial label.

Patient Information:

• PREHEVBRIO prevents hepatitis B and possibly hepatitis D.
• Administered in three injections over six months.
• Common side effects include pain at the injection site, fatigue, headache, and muscle pain.