Nomenclature for Biological Products
Nomenclature for Biological Products
Nomenclature for Biological Products
Several categories of drugs are identical to or derived from biological products. Some hormones given as drugs, for example, require special mention because the drug name differs from the name used for the endogenous substance (please note that this is not a comprehensive list of such drugs). Other categories of biologicals are derived from specific guidelines developed by USAN, outlined below.
Using the appropriate name can help clarify that the substance referred to is a drug, although for less familiar drug names it may be necessary to include the endogenous hormone name in parentheses to clarify the action of the drug for readers. (For more information on appropriate abbreviations for hormones, see 14.11, Abbreviations, Clinical, Technical, and Other Common Terms.) The following information is based on the USP Dictionary.1(pp1225-1232)
The suffix -relin denotes hypothalamic peptide hormones that stimulate release of pituitary hormones and the suffix -relix denotes hormones that inhibit release.
thyrotropin-releasing hormone (TRH)
luteinizing hormone-releasing hormone (LHRH) (or gonadotropin-releasing hormone [GnRH])
buserelin acetate, gonadorelin acetate (or hydrochloride), histrelin, lutrelin acetate, nafarelin acetate
growth hormone-releasing factor (GHRF)
growth hormone release-inhibiting factor (somatostatin, GHRIF)
After venipuncture, protirelin (synthetic thyrotropin-releasing hormone) was injected.
The som- prefix is used for growth hormone derivatives.
somatrem (methionyl human growth hormone)
somidobove, sometribove, somagrebove (bovine somatotropin derivatives)
somalapor, somenopor, sometripor, somfasepor (bovine somatotropin derivatives)
Abbreviations for thyroxine and triiodothyronine are provided in parentheses and may be used after the name is expanded at first mention.
Therapeutic Agent INN
levorotatory thyroxine (T4)
mixture of liothyronine and levothyroxine sodium
Insulin terminology can be a source of clinically important confusion, particularly with regard to insulin concentrations and types. Insulin concentrations are as follows (not necessary to expand at first mention):
U100 contains 100 U of insulin per milliliter (the most commonly used concentration).
U40 contains 40 U of insulin per milliliter.
U500 contains 500 U of insulin per milliliter.
Insulin types include those that may be administered intravenously, subcutaneously, or intramuscularly (injections) and those that may be administered only subcutaneously or intramuscularly (suspensions). Another form of insulin may be inhaled.
Insulin is prepared with the use of recombinant DNA technology (referred to as human insulin, since the source is human DNA) or as a synthetic modification of porcine insulin. Proprietary names are provided below because they are often used to refer to the potentially confusing various types of insulin preparations. For clarity and conciseness, use of proprietary terms in addition to the nonproprietary terms may be necessary in some cases. The following lists are not comprehensive but are intended to provide examples of the nonproprietary names that should be used and their corresponding proprietary names.
human insulin injection
insulin lispro injection
insulin aspart injection
insulin glargine injection
insulin zinc suspension, prompt
insulin zinc suspension
human insulin extended zinc suspension
insulin isophane suspension
NPH [neutral protamine Hagedorn]*
* NPH is the single exception to expressing drugs as abbreviations and can be used in its abbreviated form.
Insulin is available in combinations of injections and suspensions:
70% human isophane suspension/30% human insulin injection
70% insulin aspart protamine suspension/30% insulin aspart injection
Novolog Mix 70/30
75% insulin lispro protamine suspension/25% insulin lispro injection
Humalog Mix 75/25
50% insulin isophane suspension/50% human insulin injection
Interferon is defined as “the class name for a family of species-specific proteins (or glycoproteins) produced according to information encoded by species of interferon genes and exert complex antineoplastic, antiviral, and immunomodulating effects.”1(p1225) (See also 15.8, Immunology.)
The 3 main types used for therapy are as follows:
interferon alfa (formerly leukocyte or lymphoblastoid interferon) [The f is used rather than ph to avoid the confusing ph in international usage.]
interferon beta (formerly fibroblast interferon)
Subcategories are designated by a numeral and a lowercase letter. The lowercase letter after the number differentiates one manufacturer’s interferon from another's. Examples of pure interferons are as follows:
For naturally occurring mixtures of interferons, a lowercase n precedes the numeral:
There are 12 interleukin derivatives. All except interleukin 3 end in -kin (eg, aldesleukin). Interleukin 3 is designated by the -plestim stem (eg, daniplestim) and is a pleiotropic colony-stimulating factor (see also Colony-Stimulating Factors).
interleukin 1 derivatives
interleukin 1a derivatives
interleukin 1b derivatives
interleukin 2 derivatives
interleukin 4 derivatives
interleukin 5 derivatives
interleukin 6 derivatives
interleukin 7 derivatives
interleukin 8 derivatives
interleukin 9 derivatives
interleukin 10 derivatives
interleukin 11 derivatives
interleukin 12 derivatives
The suffix -grastim is used for granulocyte colony-stimulating factors (G-CSFs):
The suffix -gramostim is used for granulocyte-macrophage colony-stimulating factors (GM-CSFs):
The suffix -mostim is used for macrophage colony-stimulating factors (M-CSF):
The suffix -plestim is used for interleukin 3 (IL-3) factors, which are classified as pleiotropic colony-stimulating factors:
The suffix -distim is used for conjugates of 2 types of colony-stimulating factors:
The suffix -cestim is used for stem cell–stimulating factors:
The word epoetin is used to describe erythropoietin preparations that have an amino acid sequence that is identical to the endogenous cytokine. The words alfa, beta, and gamma are added to designate preparations with different composition and carbohydrate moieties.1(p1225)
Therapeutic monoclonal antibodies and fragments are designated by the suffix -mab. Monoclonal antibodies are derived from animals as well as from humans and the nomenclature is based on the source of the antibody (mouse, rat, hamster, primate, or human) and the disease target or antibody subclass. Some examples of monoclonal antibodies are abciximab, dacliximab, and satumomab.1(p1225-1226)
The following letters are used to identify the source of the monoclonal antibody:
These identifiers precede the -mab suffix stem, for example:
Monoclonal antibodies used to treat particular tumors are incorporated into the name using the following syllables.
Key elements are combined in the following sequence: the letters representing the target disease state, the source of the product, and the monoclonal root -mab used as a suffix (eg, biciromab, satumomab). When a target or disease stem is combined with the source stem for chimeric monoclonal antibody, the last consonant of the target/disease syllable is dropped to facilitate pronunciation:
Radiolabeled or Conjugated Products.
Some products are radiolabeled or conjugated to other chemicals such as toxins. Such conjugates are identified by a separate, second word or other chemical designation. For monoclonal antibodies conjugated to a toxin, the “-tox” stem indicates the toxin (eg, zolimomab aritox, in which the designation aritox was selected to identify ricin A-chain). For radiolabeled products, the isotope, element symbol, and isotope number precede the monoclonal antibody.1(p1226) (See also 15.9.2, Isotopes, Radiopharmaceuticals.)
technetium Tc 99m biciromab
indium In 111 altumomab pentetate
A separate term is also used to designate a linker or chelator that conjugates the monoclonal antibody to a toxin or isotope, or for pegylated (having polyethylene glycol, or PEG, attached) monoclonal antibodies.1(p1226)