fine [10:<6 months of age, are at greatest risk of mercury toxicity. 1 9 10 12 Although it has been suggested that thimerosal added as a preservative or used during manufacturing process of vaccines or plasma-derived products theoretically could have adverse effects in recipients, there is no conclusive evidence that low concentrations of thimerosal contained in vaccines cause harm in vaccine recipients. 27 28 29 32 34 35 36 37 38 39 Efforts to eliminate or reduce thimerosal content in such products are recommended as a prudent measure to reduce mercury exposure in infants and children and part of an overall strategy to reduce mercury exposures from all sources, including food and drugs. 9 10 12 27 Specific Populations Pregnancy Category C. 1 Pregnancy does not preclude use when clearly needed. 17 52 Contains mercury in the form of ethyl mercury from thimerosal; 1 22 developing fetuses are at increased risk of mercury toxicity. 1 9 10 12 (See Mercury Toxicity under Cautions.) Lactation Not known whether distributed into milk. 1 Use with caution in nursing women. 1 Pediatric Use Specific studies not conducted in pediatric patients. 1 Has been used in children as young as 14 months of age without unusual adverse effects. 18 45 47 48 Age-related dosage adjustments not indicated since venom dose following snakebite is expected to be similar in children and adults. 1 46 48 53 To avoid fluid overload, fluid volume used to dilute the antivenom may need to be adjusted in children weighing> <10 kg. 48 (See Reconstitution and Dilution under Dosage and Administration.) Contains mercury in the form of ethyl mercury from thimerosal; 1 22 young children, especially neonates and infants> <6 months of age, are at increased risk of mercury toxicity. 1 9 10 12 (See Mercury Toxicity under Cautions.) Current evidence suggests risks of untreated snake envenomation outweigh risks associated with thimerosal exposure. 48 Geriatric Use Specific studies not conducted. 1 Common Adverse Effects Urticaria, 1 4 rash, 1 4 pruritus, 1 4 nausea, 1 4 coagulation disorder, 1 4 back pain. 1 4 Interactions for CroFab No formal drug interaction studies to date. 1 CroFab Pharmacokinetics Elimination Half-life Limited data indicate distribution half-life of approximately 2.5 hours 55 and elimination half-life of approximately 12 30 hours. 1 3 4 55 Stability Storage Parenteral For Injection, for IV Infusion 2 8 C; do not freeze. 1 Use reconstituted and diluted solutions within 4 hours. 1 17 Should be refrigerated, but may be stored at room temperature if necessary. 17 Actions Preparation of venom-specific Fab fragments of ovine IgG that bind and neutralize venom toxins of Crotalinae (pit vipers, crotalines; formerly known as Crotalidae or crotalids) native to North America. 1 This facilitates redistribution of venom toxins away from target tissues and elimination from the body. 1 Mixture of 4 different monospecific antivenoms derived from serum of healthy sheep immunized with one of the following North American snake venoms: C. atrox (Western diamondback rattlesnake), C. adamanteus (Eastern diamondback rattlesnake), C. scutulatus (Mojave rattlesnake), or A. piscivorus (cottonmouth or water moccasin). 1 Each monospecific antivenom is prepared by fractionating IgG from the ovine serum, digesting it with papain, and isolating venom-specific Fab fragments using ion exchange and affinity chromatography columns. 1 Standardized by ability to neutralize lethal action of the 4 crotaline venoms following IV injection in mice (mouse LD 50 neutralizing units). 1 One neutralizing unit is determined as the amount of mixed monospecific Fab proteins necessary to neutralize one LD 50 of each of the 4 venoms, where the LD 50 is amount of venom that would be lethal in 50% of mice. 1 Each vial contains at least 1270, 420, 5570, and 780 mouse LD 50 neutralizing units of antivenom for C. atrox , C. adamanteus , C. scutulatus , and A. piscivorus , respectively. 1 Murine lethality tests indicate that the antivenom has cross-neutralizing ability with venoms from some other clinically important North American crotalines, including venoms from C. horridus atricaudatus (Canebrake rattlesnake), A. contortrix contortrix (Southern copperhead), Sistrurus miliarius barbouri (Southeastern pygmy rattlesnake), and C. horridus horridus (Timber rattlesnake), but is less potent against venoms from C. viridis helleri (Southern Pacific rattlesnake) and C. molossus molossus (Mexican black-tailed rattlesnake). 1 Advice to Patients Importance of immediately contacting a clinician if any unusual bruising or bleeding (e.g., nosebleeds, excessive bleeding after brushing teeth, blood in stools or urine, excessive menstrual bleeding, petechiae, excessive bruising or persistent oozing from superficial injuries) occurs after hospital discharge. 1 Advise patients that such bruising or bleeding may occur for 1 week or longer following initial treatment of envenomation. 1 Importance of immediately contacting a clinician if any manifestations of delayed allergic reactions or serum sickness (e.g., rash, pruritus, urticaria) occur after hospital discharge. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Crotalidae Polyvalent Immune Fab (Ovine) Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV infusion CroFab Protherics AHFS DI Essentials. Copyright 2017, Selected Revisions July 2, 2012. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Protherics Inc. Crofab (Crotalidae polyvalent immune fab [ovine]) prescribing information. Brentwood, TN; 2010 Sep. 2. Savage Laboratories. Take the bite out of Crotalid envenomation. Crofab product information. Melville, NY; 2001 Feb. 3. Anon. A new snake venom. Med Lett Drugs Ther . 2001; 43:55-6. [PubMed 11426191] 4. Dart RC,, Seifert SA, Boyer LV et al. A randomized multicenter trial of crotalinae polyvalent immune Fab (ovine) antivenom for the treatment for crotaline snakebite in the United States. Arch Intern Med . 2001; 161:2030-6. [PubMed 11525706] 5. Galli R. The antivenin is safe, but its future is uncertain. West J Med. 2001;175:91-2. Editorial. 6. Dart RC, McNally J. Efficacy, safety, and use of snake antivenoms in the United States. Ann Emerg Med. 2001;37:181-8. 7. Hill RE, Bogdan GM, Dart RC. Time to reconstitution: purified Fab antivenom vs. unpurified IgG antivenom. Toxicon. 2001;39:729-31. 8. Dart RC, Seifert SA, Carroll L et al. Affinity-purified, mixed monospecific crotalid antivenom ovine Fab for the treatment of crotalid venom poisoning. Ann Emerg Med. 1997;30:33-9. 9. Centers for Disease Control and Prevention. Recommendations regarding the use of vaccines that contain thimerosal as a preservative. MMWR Morb Mortal Wkly Rep . 1999; 48:996-8. [PubMed 10577494] 10. American Academy of Pediatrics Committee on Infectious Diseases and Committee on Environmental Health. Thimerosal in vaccines: an interim report to clinicians (RE9935). Pediatrics . 1999; 104:570-4. [PubMed 10469789] 11. Gold BS, Dart RC, Barish RA. Bites of venomous snakes. N Engl J Med . 2002; 347:347-56. [PubMed 12151473] 12. Centers for Disease Control and Prevention. Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. MMWR . 1999; 48:563-5. [PubMed 10418806] 14. Food and Drug Administration. FDA Application: Search Orphan Drug Designations and Approvals. Rockville, MD. From FDA website. Accessed 2012 Mar 12. 17. Protherics Inc, Brentwood, TN: Personal communication 18. Ruha AM, Curry SC, Beuhler M et al. Initial postmarketing experience with Crotalidae polyvalent immune Fab for treatment of rattlesnake envenomation. Ann Emerg Med . 2002; 39:609-15. [PubMed 12023703] 19. Holstege CP, Wu J, Baer AB. Immediate hypersensitivity reaction associated with the rapid infusion of Crotalidae polyvalent immune Fab (ovine). Ann Emerg Med . 2002; 39:677-9. [PubMed 12023715] 20. Clark RF, McKinney PE, Chase PB et al. Immediate and delayed allergic reactions to Crotalidae polyvalent immune Fab (ovine) antivenom. Ann Emerg Med . 2002; 39:671-6. [PubMed 12023714] 21. Aberer W. Vaccination despite thimerosal sensitivity. Contact Dermatitis . 1991; 24:6-10. [PubMed 2044374] 22. Food and Drug Administration (FDA). Mercury in plasma-derived products. From FDA website. Accessed 2012 Mar 12. 23. National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep . 2011; 60:1-64. 25. Food and Drug Administration. Thimerosal in vaccines. From FDA website. Accessed 2008 Oct 27. 27. Food and Drug Administration. Thimerosal in vaccines. Frequently asked questions (FAQ). From FDA website. Accessed 2008 Oct 27. 28. Institute of Medicine. Immunization safety review: thimerosal-containing vaccines and neurodevelopmental disorder. Washington DC; National Academy Press; 2001. From IOM website. Accessed 2003 Jul 24. 29. Thompson WW, Price C, Goodson B et al. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years. N Engl J Med . 2007; 357:1281-92. [PubMed 17898097] 30. Pichichero ME, Gentile A, Giglio N et al. Mercury levels in newborns and infants after receipt of thimerosal-containing vaccines. Pediatrics . 2008; 121:e208-14. [PubMed 18245396] 31. Zheng W, Dreskin SC. Thimerosal in influenza vaccine: an immediate hypersensitivity reaction. Ann Allergy Asthma Immunol . 2007; 99:574-5. [PubMed 18219843] 32. Madsen KM, Lauritsen MB, Pedersen CB et al. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics . 2003; 112:604-6. [PubMed 12949291] 33. Lee-Wong M, Resnick D, Chong K. A generalized reaction to thimerosal from an influenza vaccine. Ann Allergy Asthma Immunol . 2005; 94:90-4. [PubMed 15702823] 34. Parker S, Todd J, Schwartz B et al. Thimerosal-containing vaccines and autistic spectrum disorder: a critical review of published original data. Pediatrics . 2005; 115:200. [PubMed 15630018] 35. Schechter R, Grether JK. Continuing increases in autism reported to California s developmental services system: mercury in retrograde. Arch Gen Psychiatry . 2008; 65:19-24. [PubMed 18180424] 36. Andrews N, Miller E, Grant A et al. Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association. Pediatrics . 2004; 114:584-91. [PubMed 15342825] 37. Verstraeten T, Davis RL, DeStefano F et al. Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. Pediatrics . 2003; 112:1039-48. [PubMed 14595043] 38. Hviid A, Stellfeld M, Wohlfahrt J et al. Association between thimerosal-containing vaccine and autism. JAMA . 2003; 290:1763-6. [PubMed 14519711] 39. Institute of Medicine. Immunization safety review: vaccines and autism. Washington DC; National Academy Press; 2004. From IOM website. Accessed 2008 Oct 28. 40. Ruha AM, Curry SC, Albrecht C et al. Late hematologic toxicity following treatment of rattlesnake envenomation with crotalidae polyvalent immune Fab antivenom. Toxicon . 2011; 57:53-9. [PubMed 20920516] 41. Miller AD, Young MC, DeMott MC et al. Recurrent coagulopathy and thrombocytopenia in children treated with crotalidae polyvalent immune fab: a case series. Pediatr Emerg Care . 2010; 26:576-82. [PubMed 20693856] 42. Lavonas EJ, Schaeffer TH, Kokko J et al. Crotaline Fab antivenom appears to be effective in cases of severe North American pit viper envenomation: an integrative review. BMC Emerg Med . 2009; 9:13. [PubMed 19545426] 43. Cannon R, Ruha AM, Kashani J. Acute hypersensitivity reactions associated with administration of crotalidae polyvalent immune Fab antivenom. Ann Emerg Med . 2008; 51:407-11. [PubMed 18191286] 44. Schaeffer TH, Khatri V, Reifler LM et al. Incidence of Immediate Hypersensitivity Reaction and Serum Sickness Following Administration of Crotalidae Polyvalent Immune Fab Antivenom: A Meta-analysis. Acad Emerg Med . 2012; 19:121-31. [PubMed 22320362] 45. Pizon AF, Riley BD, LoVecchio F et al. Safety and efficacy of Crotalidae Polyvalent Immune Fab in pediatric crotaline envenomations. Acad Emerg Med . 2007; 14:373-6. [PubMed 17296804] 46. Behm MO, Kearns GL. Crotaline Fab antivenom for treatment of children with rattlesnake envenomation. Pediatrics . 2003; 112:1458-9; author reply 1458-9. [PubMed 14654633] 47. Richardson WH, Barry JD, Tong TC et al. Rattlesnake envenomation to the face of an infant. Pediatr Emerg Care . 2005; 21:173-6. [PubMed 15744196] 48. Offerman SR, Bush SP, Moynihan JA et al. Crotaline Fab antivenom for the treatment of children with rattlesnake envenomation. Pediatrics . 2002; 110:968-71. [PubMed 12415038] 49. Lavonas EJ, Kokko J, Schaeffer TH et al. Short-term outcomes after Fab antivenom therapy for severe crotaline snakebite. Ann Emerg Med . 2011; 57:128-137.e3. [PubMed 20952098] 50. Camilleri C, Offerman S, Gosselin R et al. Conservative management of delayed, multicomponent coagulopathy following rattlesnake envenomation. Clin Toxicol (Phila) . 2005; 43:201-6. [PubMed 15902796] 51. Johnson PN, McGoodwin L, Banner W. Utilisation of Crotalidae polyvalent immune fab (ovine) for Viperidae envenomations in children. Emerg Med J . 2008; 25:793-8. [PubMed 19033492] 52. LaMonica GE, Seifert SA, Rayburn WF. Rattlesnake bites in pregnant women. J Reprod Med . 2010 Nov-Dec; 55:520-2. 53. Lavonas EJ, Ruha AM, Banner W et al. Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med . 2011; 11:2. [PubMed 21291549] 54. Seifert SA, Boyer LV. Recurrence phenomena after immunoglobulin therapy for snake envenomations: Part 1. Pharmacokinetics and pharmacodynamics of immunoglobulin antivenoms and related antibodies. Ann Emerg Med . 2001; 37:189-95. [PubMed 11174238] 55. Boyer LV, Seifert SA, Cain JS. Recurrence phenomena after immunoglobulin therapy for snake envenomations: Part 2. Guidelines for clinical management with crotaline Fab antivenom. Ann Emerg Med . 2001; 37:196-201. [PubMed 11174239] Print this page> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More} } in vogue
carriers CroFab every now and then
EmoticonEmoticon