Antivenin (Micrurus fulvius) (equine origin) - North American Coral Snake Antivenin
Status: approved, but being discontinued
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; USA mark.
Cross ref: See the Antivenin Products entry (#906).
Description: Antivenin (Micrurus fulvius) (equine origin) is a lyophilized (freeze-dried) formulation of immune globulin (containing antibodies) obtained by fractionating blood from healthy horses (equine) immunized with eastern coral snake (Micrurus fulvius) venom. Prior to lyophilization, 0.25% phenol and 0.005% thimerosal (mercury derivative; see entry #939) are added as preservatives. The antivenin is standardized for potency in mice in terms of LD50 neutralizing capacity per mL, as determined by intravenous injection of a graded series of antivenin-venom mixtures. Based on this assay system, the reconstituted contents of each 10 mL vial will neutralize approximately 250 mouse LD50 units or about 2 mg of venom. Results of cross-neutralization studies indicate that the product will neutralize venom from M fulvius tenere (Texas coral snake), but will not neutralize the venom of Microuroides euryxanthus (Arizona or Sonoran coral snake).
Nomenclature: Antivenin (Micrurus fulvius) [BIO]; Antivenin (Micrurus fulvius) (equine origin) [FDA]; North American Coral Snake Antivenin [SY]; Micrurus fulvius antivenin [SY]; NDC 0008-0407-03 [NDC]
Companies.: Antivenin (Micrurus fulvius) was manufactured by Wyeth Pharmaceuticals, Marietta, PA; CBER/FDA est. no. 0003. It was marketed in the U.S. and internationally by Wyeth and affiliates. Wyeth has sold its Marietta, PA, facilities. Marketing will halt once current supplies are exhausted.
FDA class: Biologic PLA
CBER class: Antitoxins, Antivenins, Enzymes and Venoms
Approvals: Date = 19670828; first approval
Indications: [derived from product insert/labeling]:
The product is used for neutralization of snake venom (poisonous snake bites) by Micrurus fulvius, the North American coral snake, and certain related snakes. The insert/labelling states, “If symptoms or signs of envenomization occur in a patient under observation or are already present at the time the patient is first seen, give Antivenin (Micrurus fulvius) promptly by the intra-venous route.” Also, “some envenomated patients may require administration of the contents of 10 or more vials to neutralize the venom dose injected by the biting snake if the entire venom load were delivered by the bite(s).”
Status: Wyeth is discontinuing this product. Manufacturing has been halted. Marketing will cease after supplies are depleted.
This product is, presumably, also approved or used (under equivalents of IND, named patient use, compassionate IND, etc.) in other North American countries.
As of mid-2012, the BLA was still approved (not withdrawn) with the product considered "discontinued," meaning it is exempt from annual CBER user fees. It was converted to discontinued on Oct. 1, 2007.
Medical: Coral snakebites are not always followed by envenomization (injection of venom). Severe or even fatal envenomization from coral snakebites can occur without any significant local tissue reaction. Systemic signs of envenomization usually begin one to seven hours after the bite, but may be delayed up to 18 hours. The product insert states that any coral snakebiten person should be hospitalized for observation and/or treatment. The insert also states, “If symptoms or signs of envenomization occur in a patient under observation or are already present at the time the patient is first seen, give Antivenin (Mic-rurus fulvius) promptly by the intravenous route.”
Disease: Although not approved as such, this is very much an orphan product in terms of the U.S. market. There are an about 20 ± 5 reported coral snakebites annually in the U.S. These are not always followed by envenomization, so not all of these may be treated with antivenin.
Market: The 2007 Average Wholesale Price (AWP) is $1,641.00/kit, and the Direct Price (Manufacturer’s discount price) is $1,368.00/kit (Red Book, 2007).
Treatment of severe envenomizations, e.g., requiring 10 or more vials, can be rather costly, e.g., over $15,000.
Companies involvement:
Full monograph
910 Antivenin (Micrurus fulvius)
Nomenclature:
Antivenin (Micrurus fulvius) [BIO]
Antivenin (Micrurus fulvius) (equine origin) [FDA]
Micrurus fulvius antivenin [SY]
North American Coral Snake Antivenin [SY]
NDC 0008-0407-03 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1967
Date of 1st FDA approval = 19670828
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
equine immune globulins <!-- immunoglobulins -->
equine materials used
immune globulins, equine <!-- immunoglobulins -->
coral snakes
equine plasma/serum
Micrurus fulvius
North American coral snake
plasma proteins, immunoglobulin-depleted
snake venoms
snake venoms
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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