Form: Solution for intramuscular injection (150 IU/mL)
Manufacturer: Kamada Ltd.
Imported by: Quality & Compliance Services Inc. for Valneva Canada Inc.
Indications and Clinical Use
Indication: Passive, transient post-exposure prophylaxis of rabies infection, to be administered immediately after exposure to a rabid or potentially rabid animal, alongside a full course of rabies vaccine.
Dosage and Administration
Dose: 20 IU/kg body weight.
Administration:
Administer as much of the dose as possible into and around any detectable bite wounds.
Inject the remaining dose intramuscularly at a site distant from the rabies vaccine administration.
Do not administer intravenously or in the same anatomical site as the rabies vaccine.
If the bite site is unknown or undetectable, administer the full dose intramuscularly.
Contraindications
None known.
Warnings and Precautions
Transmissible Infectious Agents: As KamRAB is derived from human plasma, it may carry a risk of transmitting infectious agents despite screening and inactivation procedures.
Thrombosis: Monitor patients at increased risk of thrombosis.
Hemolysis: Monitor for signs of hemolysis in patients at risk.
Anaphylactic Reactions: KamRAB should not be injected into a blood vessel due to the risk of severe allergic reactions. Discontinue immediately if an anaphylactic reaction occurs.
Live Attenuated Virus Vaccines: KamRAB may interfere with the development of an immune response to live attenuated virus vaccines (e.g., measles). Avoid immunization with live vaccines within 3-4 months after KamRAB administration.
Adverse Reactions
Common: Injection site pain, headache, muscle pain, upper respiratory tract infection, joint pain, dizziness, fatigue, abdominal pain, blood in urine, nausea, feeling faint, bruising, and white blood cells in urine.
Rare: Anaphylactic reactions, fever, chills, dark urine.
Drug Interactions
Concomitant Vaccine Administration: Do not administer additional doses of KamRAB once vaccination has started, as it may interfere with the immune response to the vaccine. Avoid immunization with live vaccines within 3-4 months after KamRAB administration.
Storage and Stability
Store at 2°C to 8°C. Do not freeze. Keep vial in the carton until use. KamRAB may be stored at room temperature (up to 25°C) for up to one month. Use within one month after removal from refrigeration and do not return to refrigeration. Do not use after the expiration date.
Clinical Trials and Efficacy
Study Results: KamRAB demonstrated non-inferiority to comparator HRIG in providing passive rabies virus neutralizing antibody protection when administered with a full course of rabies vaccine. Nearly all subjects achieved protective antibody levels by day 14.
