The following guidelines have been developed for monoclonal antibodies:
1. The suffix -mab is used for monoclonal antibodies and fragments.
2. Identification of the animal source of the product is an important safety factor based on the number of products that may cause source-specific antibodies to develop in patients.
The following letters were approved as product source identifiers:
u = human
o = mouse
a = rat
zu = humanized
e = hamster
i = primate
xi = chimera
axo = rat/mouse
xizu = combination of humanized and chimeric chains
These identifiers are used as infixes preceding the -mab suffix stem, eg:
-umab (human)
-omab (mouse)
-ximab (chimera)
-zumab (humanized)
Subclasses
The general disease state subclass must be incorporated into the name by use of a code syllable. The following disease state subclasses were approved based on products currently before the Council. Additional subclasses will be added as necessary.
Disease or Target Class:
Viral | -vir- |
Bacterial | -bac- |
Immune | -lim- |
Infectious Lesions | -les- |
Cardiovascular | -cir- |
Antifungal | -fung- |
Neurologic | -ner- |
Interleukins | -kin- |
Musculoskeletal | -mul- |
Bone | -os- |
Toxin as target | -toxa- |
Tumors
Adalimumab
infliximab
colon | -col- |
melanoma | -mel- |
mammary | -mar- |
testis | -got- |
ovary | -gov- |
prostate | -pr(o)- |
miscellaneous | -tum- |
- In order to create a unique name, a distinct, compatible syllable should be selected as the starting prefix.
- Sequence of stems: The order for combining the key elements is as follows: Infix representing the target disease state, the source of the product, and the monoclonal root -mab used as a suffix (eg, biciromab, satumomab, nebacumab, sevirumab, tuvirumab). When combining a target or disease infix stem with the source stem for chimeric monoclonal antibody, the last consonant of the target/disease syllable is dropped, eg:
TARGET | SOURCE | -MAB STEM | USAN |
-cir- | -xi | -mab | abciximab |
-lim- | -zu | -mab | daclizumab |
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