Scorpion (centruroides) immune Fab2 antivenin (equine)

Identification

Summary

Scorpion (centruroides) immune Fab2 antivenin (equine) is a purified preparation of immunoglobulin gamma antibodies used to treat scorpion stings.

Brand Names

Anascorp

Generic Name

Scorpion (centruroides) immune Fab2 antivenin (equine)

DrugBank Accession Number

DB13905

Background

Centruroides (scorpion) Immune F(ab')2 (equine) is a purified preparation of immune globulin F(ab’)2 fragments that are derived from plasma of the horses immunized with venom of C. noxius, C. l. limpidus, C. l. tecomanus, and C. s. suffusus. It is intravenously administered patients with clinical signs of scorpion envenomation so that the Fab fragments bind to the toxins and limit systemic toxicity. It was approved by FDA in 2011 and is marketed under the name Anascorp ⁴.

Anascorp is produced from equine IgG antibodies. Because initial development and use of this product in Mexico, venoms from several Centruroides species endemic to Mexico are pooled and diluted ¹⁴.

This drug is a polyvalent antivenin proven to be useful against scorpion stings. It is the first specific treatment to neutralize toxin from Centruroides scorpion stings, particularly those of the Centruroides sculpturatus in the United States ¹³.

Envenomation by a scorpion sting can result in serious cardiovascular effects ². Severe scorpion stings may cause loss of muscle control and respiratory failure, warranting heavy sedation and hospitalization in an intensive care unit. Most commonly, children experience severe reactions, however, adults can be affected, too ³, ⁴, ⁶.

Type

Biotech

Groups

Approved

Biologic Classification

Protein Based Therapies
Other protein based therapies

Protein Chemical Formula

Not Available

Protein Average Weight

Not Available

Sequences

Not Available

Synonyms

• Antivenin, scorpion
• Antivenin,centruroides immune Fab2
• Centruroides (scorpion) Immune F(ab')2 (equine)
• Centruroides (scorpion) immune F(ab')2 (equine) injection
• Centruroides (scorpion) immune F(ab)2 intravenous (equine)
• Centruroides (scorpion) immune Fab2 (equine)
• Centruroides antivenin
• Centruroides antivenin (equine)
• Centruroides Fab2 antivenin (equine)
• Centruroides suffusus suffusus) (equine)
• Mexican scorpion (centruroides) Fab2 antivenin (equine)
• Polyvalent mexican scorpion antivenin (horse)
• Scorpion (centruroides) Fab2 immunoglobulin (equine)

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Pharmacology

Indication

Indicated for treatment of clinical signs of scorpion envenomation ³, ⁴.

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Reversal of	Venom poisoning caused by scoprion		••••••••••••

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Pharmacodynamics

In 2008, 15 522 scorpion envenomations were reported to the National Poison Data System in the USA, with one fatality ocurring in a toddler. In the United States, Centruroides sculpturatus, commonly known as the Arizona bark scorpion, is the only scorpion species whose venom is toxic to humans. Though most Centruroides scorpion stings in adults are well-tolerated with minimal effects, pediatric patients are quite susceptible to signicant morbidity from the venom ¹⁴.

In a pharmacokinetic study of 1534 patients, 95-100% of the study group were relieved of systemic signs associated with scorpion envenomation in less than four hours after initiating Anascorp treatment. In the historical control database, only 3.1% of patients experienced relief of symptoms within 4 hours of hospital admission ^Label. Clinical manifestations of scorpion sting and envenomation include sweating, salivation, cool extremities, priapism, hypertension or hypotension, and tachycardia ⁹.

In 1396/1534 patients, the average time from the start of Anascorp infusion to the resolution of clinical signs and symptoms of envenomation was 1.42 hours (0.2 to 20.5 hours). Pediatric patients were found to experience a slightly faster time to resolution (1.28 ± 0.8 hours) compared to that of adult patients (1.91 ±1.4 hours). The time to resolution of symptoms was not affected by use of sedatives (474 patients who received sedatives resolved in 1.49 ± 1.1 hours and 922 patients who did not receive sedatives resolved in 1.38 ± 0.9 hours) ^Label.

Mechanism of action

Anascorp, the trade name of this drug, is composed of venom-specific F(ab’)2 fragments of immunoglobulin G (IgG) that bind to and neutralize venom toxins, promoting redistribution away from target tissues and subsequent elimination from the body ^Label.

Absorption

Not Available

Volume of distribution

Steady state: 13.6 ± 5.4 L ^Label.

Protein binding

Not Available

Metabolism

Not Available

Route of elimination

Not Available

Half-life

159 ± 57 h ^Label.

Clearance

83.5 ± 38.4 ml/Hr ^Label

Adverse Effects

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Toxicity

The most common adverse reactions observed in ≥ 2% of patients in the clinical studies for Anascorp were: vomiting, pyrexia, rash, nausea, and pruritus ^Label.

Severe hypersensitivity reactions, including anaphylaxis, may occur with Anascorp ¹⁰, ^Label. Diligent patient monitoring for hypersensitivity reactions and preparation for intravenous therapy using epinephrine, corticosteroids, and diphenhydramine hydrochloride is recommended during the infusion. If an anaphylactic reaction occurs during the Anascorp infusion, case administration immediately, and administer warranted emergency medical care ^Label.

Patients with existing allergies to horse protein are at a higher risk for developing anaphylactic reactions. Patients who have had previous therapy with Anascorp or another equine antivenom/antitoxin may have become sensitized to equine proteins and be at an elevated risk for a severe hypersensitivity reaction ^Label.

Trace amounts of cresol from the manufacturing process are contained in Anascorp. Localized reactions and generalized myalgias have been observed with the use of cresol as an injectable excipient ^Label.

Monitor patients with follow-up visit(s) for signs and symptoms of delayed allergic reactions or serum sickness (symptoms include rash, fever, myalgia, arthralgia), and treat appropriately if necessary. Eight out of 1,534 (0.5%) patients in the clinical trials exhibited symptoms suggestive of serum sickness ^Label.

Anascorp is created from equine (horse) plasma, it may carry a risk of transmitting infectious agents, e.g., viruses ^Label.

The following adverse reactions have been identified during post-approval use of Anascorp: chest tightness, palpitations, rash, and pruritus. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure ^Label.

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Interactions

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Not Available

Food Interactions

No interactions found.

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Anascorp	Injection, powder, lyophilized, for solution	7.0 mg/1mL	Intravenous	Rare Disease Therapeutics, Inc	2011-08-03	Not applicable

Unapproved/Other Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
ACSERA 5 ML ENJEKSIYONLUK COZELTI KONSANTRESI ICEREN FLAKON	Scorpion (centruroides) immune Fab2 antivenin (equine) (100 IU/5mL)	Injection	Intramuscular; Intravenous; Subcutaneous	VETAL SERUM VE BİYOLOJİK ÜRÜNLER ÜRETİMİ SAN. VE TİC. A.Ş.	2013-12-03	Not applicable

Categories

Drug Categories

• Antivenins
• Passively Acquired Immunity
• Venom Neutralization

Chemical TaxonomyProvided by Classyfire

Description

Not Available

Kingdom

Organic Compounds

Super Class

Organic Acids

Class

Carboxylic Acids and Derivatives

Sub Class

Amino Acids, Peptides, and Analogues

Direct Parent

Peptides

Alternative Parents

Not Available

Substituents

Not Available

Molecular Framework

Not Available

External Descriptors

Not Available

Affected organisms

• Humans and other mammals

Chemical Identifiers

UNII

DDA050FCEA

CAS number

Not Available

References

General References

1. Sanaei-Zadeh H: Hypersensitivity reaction to scorpion antivenom. Indian Dermatol Online J. 2014 Nov;5(Suppl 1):S51-2. doi: 10.4103/2229-5178.144536. [Article]
2. Bawaskar HS, Bawaskar PH: Efficacy and safety of scorpion antivenom plus prazosin compared with prazosin alone for venomous scorpion (Mesobuthus tamulus) sting: randomised open label clinical trial. BMJ. 2011 Jan 5;342:c7136. [Article]
3. Antidote Relieves Scorpion Stings [Link]
4. Anascorp [Link]
5. Scorpion antivenin approved [Link]
6. FDA Approves First-Ever Antivenom for Scorpion Stings [Link]
7. Efficacy and safety of scorpion antivenom plus prazosin compared with prazosin alone for venomous scorpion (Mesobuthus tamulus) sting: randomised open label clinical trial [Link]
8. Management of scorpion envenoming: a systematic review and meta-analysis of controlled clinical trials [Link]
9. Emerging options for the management of scorpion stings [Link]
10. Hypersensitivity reaction to scorpion antivenom [Link]
11. Adverse reactions to snake antivenom, and their prevention and treatment [Link]
12. Centruroides (Scorpion) Immune F(ab′)2 (Equine) [Link]
13. PDR drug reference [Link]
14. Utah poison control [Link]

External Links

PubChem Substance

347911474

RxNav

1119986

FDA label

Download (142 KB)

Clinical Trials

Clinical Trials

Phase	Status	Purpose	Conditions	Count
3	Completed	Treatment	Scorpion Sting Envenomation	1
3	Completed	Treatment	Scorpion Stings	1
2, 3	Completed	Treatment	Scorpion Sting Envenomation	2

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Injection	Intramuscular; Intravenous; Subcutaneous	100 IU/5mL
Injection, solution	Intravenous
Injection, powder, lyophilized, for solution	Intravenous	7.0 mg/1mL

Prices

Not Available

Patents

Not Available

Properties

State

Not Available

Experimental Properties

Not Available

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Drug created at September 08, 2017 20:22 / Updated at June 19, 2021 00:27