Monoclonal antibodies
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
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
These modifications were deemed necessary to facilitate pronunciation of the resultant designation.
- If the product is radiolabeled or conjugated to another chemical such as a toxin, identification of this conjugate is accomplished by use of a separate, second word or other acceptable chemical designation. For monoclonals conjugated to a toxin, the "-tox" stem must be included as part of the name selected for the toxin (eg, zolimomab aritox, the designation aritox was selected to identify ricin A-chain). For radiolabeled products, the word order is: name of the isotope, element symbol, isotope number, and name of the monoclonal antibody: eg,
technetium Tc 99m biciromab
indium In 111 altumomab pentetate
- A separate, distinct name must be assigned to any linker/chelator used to conjugate the monoclonal antibody to a toxin, isotope, or for pegylated monoclonal antibodies, eg,
telimomab aritox
indium In 111 satumomab pendetide
enlimomab pegol
For the USAN Council to initiate the selection of a nonproprietary name for a monoclonal antibody or fragment, the nomenclature application must provide the following relevant information:
1. The immunoglobulin class and subclass and the type of associated light chain.
2. Identity of the fragment of the immunoglobulin used (if applicable).
3. Species source from which the coding region for the immunoglobulin originated and specific, complete origin of all parts of chimeric, humanized, or semisynthetic immunoglobulins.
4. The antigen specificity of the immunoglobulin, including its source.
5. The clone designation (specify if vector or vector-cell combination).
6. For conjugated monoclonal antibodies, the identity of any linkers, chelators, toxins, and/or isotopes present in the product.
7. Identity of other modifications to the antibody, eg, reduction of disulfide bonds, glycosylation or deglycosylation, amino acid modification, or substitution.
8. The complete amino acid sequence, in an editable MS word format.
