Anascorp Centruroides

Anascorp [Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection] is a sterile, nonpyrogenic, lyophilized, polyvalent preparation of equine immune globulin F(ab')2 fragments, manufactured from plasma of horses immunized with venom of C. noxius, C.l. limpidus, C.l. tecomanus, and C.s.sujjusus. The product is obtained by pepsin digestion of horse plasma to remove the Fc portion o f immune globulin, followed by fractionation and purification steps. The F(ab')2 content is not less than 85%, F(ab) content is not more than 7%, and the product contains less than 5% intact immunoglobulin. Each vial of Anascorp contains 45-80 milligrams of sodium chloride, 4.3-38.3 milligrams of sucrose, and 6.6-94.9 milligrams of glycine as stabilizers. Trace amounts of pepsin, cresol ( < 0.41 mg/vial), borates ( < 1 mg/vial), and sulfates ( < 1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 milligrams of protein and will neutralize at least 150 LD50 of Centruroides scorpion venom in a mouse neutralization assay.

The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment, and nanofiltration.

Dosage Forms And Strengths

Each vial of Anascorp contains a sterile, lyophilized preparation containing not more than 120 milligrams total protein and not less than 150 LDso (mouse) neutralizing units.

Storage And Handling

Anascorp is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted, each vial contains not more than 24 milligrams per milliliter of protein, and not less than 150 mouse LDso neutralizing units.

Each box contains 1 vial of Anascorp.

NDC 66621-0150-1

Store at room temperature (up to 25 °C (77 °F)). Brief temperature excursions are permitted up to 40 “C (104°F).

DO NOT FREEZE.

Discard partially used vials.

REFERENCES

2. Curry SC, Vance MV, Ryan PJ, Kunkel DB, Northey WT. Envenomation by the scorpion Centruroides sculpturatus, J Toxicol Clin Toxicol, 1983- 1984;21(4-5):417-49.

3. GiblyR, Williams M, Walter FG, McNally J, Conroy C, Berg RA. Continuous intravenous midazolam infusion for Centruroides exilicauda scorpion envenomation. AnnEmergMed, 1999;34(5):620-5.

4. Vasquez H, Chavez-Haro A, Garcia-Ubbelohde W, et al. Pharmacokinetics of a F(ab')2 scorpion antivenin in healthy human volunteers. Toxicon, 2005;46:797-805.

5. Boyer LV, Theodorou AA, Berg RA, Mallie J. Antivenom for Critically 111 Children with Neurotoxicity from Scorpion Stings. NEngl J Med, 2009;360:2090-8.

Manufactured by: Ihstituto Bioclon S.A. de C.V., Mexico D.F., Mexico www.bioclon.com.mx. Manufactured for: Rare Disease Therapeutics, 2550 Meridian Blvd., Suite 150, Franklin, TN 37067, www.raretx.com. Distributed by: AnovoRx Distribution, LLC, 1710 North Shelby Oaks Drive, Suite 6, Memphis, TN 38134. Revised: Aug 2011