10/28/2023
Since we are starting to get questions about Librela for dogs, I wanted to share some info. We have some concerns about it and will NOT be recommending its use. You can check out this new drug on the manufacturer Zoetis's website and read the full product prescribing information. I have copied and pasted a small part of it, and the link to the full document, at the end of what will be a long post here.
Librela (Bedinvetmab) is a new treatment for osteoarthritis pain in dogs. It's a synthetic monoclonal antibody which blocks the transmission of pain signals in the body by inactivating a specific protein called Nerve Growth Factor. It's meant to be given as a monthly injection by veterinarians. Because of its effects on nerve growth, it is unsafe for use in pregnant or nursing females. It has also NOT been evaluated in dogs younger than 12 months of age, dogs with ACL tears, or dogs being treated with NSAIDs (the class of anti-inflammatory drugs commonly used in dogs to treat arthritis pain, including Rimadyl, Metacam, Deramaxx, et. al). Its interactions with veterinary vaccines have not been investigated, nor its long term effects on dogs with heart disease.
According to the prescribing fact sheet from the manufacturer:
"LIBRELA should not be used in breeding dogs or in pregnant or lactating dogs. Immunoglobulin G class
antibodies such as LIBRELA can pass through the placental blood barrier and be excreted in milk. Fetal
abnormalities, increased rates of stillbirths and increased postpartum fetal mortality were noted in rodents
and primates receiving anti-NGF monoclonal antibodies...
WARNINGS ..
Pregnant women, women trying to conceive, and breastfeeding women should take extreme care to avoid
accidental self-injection.
The importance of Nerve Growth Factor in ensuring normal fetal nervous system development is
well-established and laboratory studies conducted on nonhuman primates with human anti-NGF
antibodies have shown evidence of reproductive and developmental toxicity."
PRECAUTIONS
"Administration of monoclonal antibodies may be associated with hypersensitivity reactions...
Evaluations were not made to determine if interactions occurred between LIBRELA and veterinary vaccines.
Treatment with LIBRELA may result in the formation of anti-bedinvetmab antibodies and potentially the
loss of product effectiveness (see IMMUNOGENICITY).
The safe use of anti-NGF monoclonal antibodies with concurrent non-steroidal anti-inflammatory drugs
(NSAIDs) has not been established in dogs. In human clinical trials, rapidly progressing osteoarthritis (RPOA)
has been reported in a small number of patients receiving humanized anti-NGF monoclonal antibody
therapy. The incidence of these events increased in human patients receiving NSAID treatment long term in
combination with an anti-NGF monoclonal antibody. RPOA has not been characterized or reported in dogs.
The safety and effectiveness of LIBRELA has not been evaluated in dogs less than 12 months of age.
LIBRELA has not been studied in dogs that have a history of cruciate ligament rupture within six months
before initial product use as these cases were excluded from the field studies.
Long term effects which may occur more than 9 months after the use of LIBRELA have not been evaluated.
NGF is expressed within the heart and vasculature, and the long-term effects of reduced NGF in dogs with
cardiac disease are unknown.
Primates receiving high doses of anti-NGF monoclonal antibodies had anatomical changes in postganglionic
cell bodies (reduced size and number of neurons). The change in cell body size returned to normal after
anti-NGF monoclonal antibody administration was discontinued. NGF is involved in the normal development
of sensory and sympathetic nerve fibers in developing animals. This may be important with use of LIBRELA
in young growing dogs."
Here is the link to the full product fact sheet:
