The US Food and Drug Administration (FDA) has approved a human plasma-derived rabies immune globulin (Kedrab, Kedrion Biopharma and Kamada Ltd) for passive, transient postexposure prophylaxis of rabies infection, the companies have announced.
Kedrab should be given immediately after contact with a rabid or possibly rabid animal, concurrently with a full course of rabies vaccine. Repeat doses of Kedrab should not be administered once vaccine treatment is started because they may interfere with the immune response to the rabies vaccine.
“Rabies is a deadly but entirely preventable disease, and we are pleased to offer physicians another safe and effective option,” Paolo Marcucci, president and chief executive officer of Kedrion, said in a news release.
The approval of Kedrab was based on positive data from a prospective, randomized, double-blind noninferiority phase 2/3 study of 118 healthy adults (mean age, 45 years). Half received Kedrab and half received a comparator human rabies immune globulin at a dose of 20 IU/kg intramuscularly on day 0, and rabies vaccine on days 0, 3, 7, 14, and 28.
Kedrab has been on the market since 2006 in numerous territories outside of the United States under the brand name KamRAB. Kamada has sold more than 1.4 million vials of KamRAB to date, “demonstrating significant clinical experience with the product,” the companies said in the release.
The most common adverse reactions in patients treated with Kedrab were injection site pain, headache, muscle pain, and upper respiratory tract infection.
The Kedrab label advises that patients who can document previous complete rabies preexposure prophylaxis or complete postexposure prophylaxis should receive only a booster rabies vaccine without Kedrab because the agent may interfere with the anamnestic response to the vaccine.
Kedrab should not be injected into a blood vessel because of the risk for severe allergic or hypersensitivity reactions, including anaphylactic shock. Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity.
Full prescribing information for Kedrab is available online.
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