Type: Hepatitis B Immune Globulin (Human), Solvent/Detergent Treated
Form: Injectable solution, ≥220 IU/mL
Manufacturer: Grifols Therapeutics Inc.
Distributor: Grifols Canada Ltd.
Indications and Clinical Use
Post-Exposure Prophylaxis:
Acute Exposure: For individuals exposed to blood containing HBsAg via needlestick, mucous membrane contact, or oral ingestion.
Perinatal Exposure: For infants born to HBsAg-positive mothers.
Sexual Exposure: For sexual partners of HBsAg-positive individuals.
Household Exposure: For infants exposed to caregivers with acute HBV infection.
Contraindications
Hypersensitivity to the drug or any ingredient in the formulation.
Severe thrombocytopenia or coagulation disorders contraindicating intramuscular injections.
Warnings and Precautions
General: Intramuscular use only. Do not administer intravenously. Products made from human plasma may contain infectious agents.
Hypersensitivity: Caution in patients with a history of allergic reactions to immune globulin preparations. Epinephrine should be available.
Special Populations:
Pregnant Women: Use only if clearly needed; no data from clinical trials.
Pediatrics: Safety and effectiveness in neonates and infants up to 12 months established; not for use in other pediatric populations without established safety data.
Adverse Reactions
Common: Local pain and tenderness at the injection site, urticaria, angioedema.
Severe: Rare cases of anaphylactic reactions.
Drug Interactions
Live Viral Vaccines: May interfere with live vaccines (except measles). Avoid live vaccines within 3 months post-administration.
Hepatitis B Vaccine: Can be administered concurrently at a different site without interfering with the immune response.
Dosage and Administration
Dosing Considerations: Generally administered with hepatitis B vaccine for enhanced efficacy.
Recommended Dose:
Acute Exposure: 0.06 mL/kg intramuscularly as soon as possible after exposure.
Perinatal Exposure: 0.5 mL IM to newborns within 12 hours of birth.
Sexual Exposure: 0.06 mL/kg IM within 14 days of last sexual contact.
Household Exposure: 0.5 mL IM for infants ≤12 months.
Administration Instructions
Administer intramuscularly, preferably in the anterolateral thigh or deltoid muscle. Avoid gluteal region to prevent sciatic nerve injury.
Use UltraSafe® Needle Guard for safe disposal.
Overdosage
No specific data available; likely to cause pain and tenderness at the injection site.
Pharmacology
Mechanism of Action: Provides passive immunization by supplying antibodies against hepatitis B.
Pharmacokinetics: Detectable antibody levels within 24 hours, persisting for approximately 2 months.
Storage and Stability
Store at 2-8°C, do not freeze. Use immediately after opening; discard unused portions.
