Children's Hospitals Today - Fall 2023 - 24

INDICATIONS AND USAGE
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS: Patients who can document previous complete rabies pre-exposure
prophylaxis or complete post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB
because KEDRAB may interfere with the anamnestic response to the rabies vaccine.
HYPERSENSITIVITY REACTIONS: 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.
LIVE ATTENUATED VIRUS VACCINES: KEDRAB administration may interfere with the development of an
immune response to live attenuated virus vaccines. If feasible, delay immunization with measles vaccine for 4
months, and other live attenuated virus vaccines for 3 months, after KEDRAB administration.
INTERFERENCE WITH SEROLOGICAL TESTING: A transient rise of the various passively transferred antibodies
in the patient's blood may result in misleading positive results of serologic tests after KEDRAB administration.
Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, and D, may interfere with serologic tests
for red cell antibodies such as the antiglobulin test (Coombs' test).
TRANSMISSIBLE INFECTIOUS AGENTS: Because KEDRAB is made from human plasma donors hyperimmunized
with rabies vaccine, it 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. All
infections suspected by a physician possibly to have been transmitted by this product should be reported by
the physician or other healthcare provider to Kedrion Biopharma Inc. at 1-855-353-7466.
ADVERSE REACTIONS: The most common adverse reactions in adult subjects treated with KEDRAB in clinical
trials were injection site pain, headache, muscle pain, joint pain, dizziness, and fatigue. In pediatric subjects
treated with KEDRAB and a full course of rabies vaccine, the most common adverse reactions were injection
site pain, headache, fever, pain in extremity, bruising (hematoma), fatigue and vomiting. Less common adverse
reactions (≤5%) in pediatric patients were injection site redness (erythema), injection site swelling (edema),
muscle pain, oral pain, and wound complication. Insomnia was reported as a less common adverse reaction
(<5%) in pediatric patients occurring after 14 days of administration.
DRUG INTERACTIONS: 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). 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.
To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-353-7466 or
the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Brief Summary of Full Prescribing Information on following page.
Reference: 1. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2021.

http://www.fda.gov/medwatch

Children's Hospitals Today - Fall 2023

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