Human rabies virus immune globulin

KEDRAB is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. KEDRAB is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal.

Rabies is a zoonotic disease caused by RNA viruses in the family Rhabdoviridae, genus Lyssavirus. Virus is typically present in the saliva of rabid mammals and is transmitted primarily through a bite. KEDRAB is infiltrated into the inoculation site(s) in previously unvaccinated persons, to provide immediate passive rabies virus neutralizing antibody protection until the patient's immune system responds to vaccination by actively producing antibodies.

For wound infiltration and intramuscular use. Post-exposure prophylaxis: single dose of KEDRAB with a full course of rabies vaccine 20 IU/kg body weight KEDRAB Do not exceed recommended dose. Do not repeat KEDRAB doses once vaccine treatment is initiated. Administer as soon as possible after exposure Infiltrate area around wound with full dose Inject any remaining KEDRAB intramuscularly, at a site distant from the site of rabies vaccine administration

None. None.

Do not give KEDRAB to persons who have completed rabies pre- or post-exposure prophylaxis because it can interfere with the anamnestic response to the rabies vaccine. Hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. IgA deficient patients with antibodies against IgA are at greater risk. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. Interference with live attenuated virus vaccines. KEDRAB is made from human plasma, and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions (>5%) observed in adult subjects were injection site pain, headache, muscle pain, joint pain, dizziness, and fatigue. The most common adverse reactions (>5%) observed in pediatric patients were injection site pain, headache, pyrexia, plain in extremity, bruising, fatigue and vomiting.

Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis and have a confirmed adequate rabies antibody titer should receive only a booster rabies vaccine (without KEDRAB) because KEDRAB may interfere with the anamnestic response to the vaccine (ACIP) 1. KEDRAB can interfere with the immune response to the rabies vaccine. For this reason, do not exceed the recommended KEDRAB dose or give additional (repeat) doses of KEDRAB once rabies vaccination has been initiated. KEDRAB can inactivate the rabies vaccine. For this reason, do not administer KEDRAB in the same syringe as the rabies vaccine or near the anatomical site of administration of the rabies vaccine. KEDRAB contains other antibodies that may interfere with the response to live vaccines such as measles, mumps, polio or rubella.

Store KEDRAB at 2-8 °C (36-46 °F). DO NOT FREEZE. KEDRAB may be stored at room temperatures not exceeding 25 °C (77 °F) for up to one month. Use within one month after removal from refrigeration. Do not return to refrigeration.