      Document 0155
 DOCN  DRG0155
 UNIQUE IDENTIFIER        DRG-0092
 NAME OF SUBSTANCE        Cryptosporidium Immune Whey Protein
                          Concentrate (Bovine) [FDA 068A]
 SYNONYMS                 Cow's milk immune globulin [FDA 068A]
 SYNONYMS                 Hyperimmune bovine colostrum [AmFAR Tx Dir
                          1995;7(4)]
 SYNONYMS                 Cryptosporidium hyperimmune bovine colostrum
                          IgG concentrate [FDA 081A]
 SYNONYMS                 BACI [AmFAR Tx Dir 1995;7(4)]
 SYNONYMS                 Bovine anti-cryptosporidium immunoglobulin
                          [AmFAR Tx Dir 1995;7(4)]
 PROTOCOL ID NUMBERS      FDA 068A
 PROTOCOL ID NUMBERS      FDA 081A
 SECONDARY SOURCE ID      WPC-S123
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Cows are immunized with
                          cryptosporidium organisms and subsequently
                          make antibodies which spill into milk the
                          cows produce. Whey, collected from milk, is
                          given to cryptosporidiosis-infected humans
                          and is speculated to cause an
                          antigen/antibody interaction.  However, the
                          exact mechanism of action is unknown.  [Dr.
                          Gergich, Stolle Milk Biologics International,
                          Jan 1990] [The Extra Pharmacopoeia 1993]
 DISEASES STUDIED/TREATED Under investigation for treatment of
                          cryptosporidiosis (cryptosporidium-associated
                          diarrhea) [AmFAR Tx Dir 1995;7(4)] [FDA 068A]
                          [Arch Dis Child 1993;70(4)]
 CLASSIFICATION CODE      Antidiarrheal [FDA 068A]
 CONTRAINDICATIONS        Contraindicated in patients with known
                          allergy or intolerance to milk products. [FDA
                          068A]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: An immune-globulin product
                          which has been concentrated and pasteurized
                          in such a way that its natural antibodies are
                          not destroyed [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: These antibodies may form a
                          protective barrier on the intestines to
                          prevent damage from such organisms as
                          cryptosporidium [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Powdered cow's milk,
                          specifically the whey portion, collected and
                          dried from cows immunized with
                          cryptosporidium organisms [Dr. Gergich,
                          Stolle Milk Biologics International, Jan
                          1990]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Oral, milk powder. [Dr. Gergich,
                          Stolle Milk Biologics International, Jan
                          1990]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Oral. [AmFAR Tx Dir
                          1995;7(4)]
 SUBSTANCE DELIVERY DATA  STORAGE: Cool, dry place as with any
                          milk-powder product. [Dr. Gergich, Stolle
                          Milk Biologics International, Jan 1990]
 REFERENCES               Ritchie DJ, Becker ES. Update on the
                          mangement of intestinal cryptosporidiosis in
                          AIDS. Ann Pharmacother. 1994
                          Jun;28(6):767-78.
 REFERENCES               Shield J, Melville C, Novelli V, Anderson G,
                          Scheimberg I, Gibb D, Milla P. Bovine
                          colostrum immunoglobulin concentrate for
                          cryptosporidiosis in AIDS [see comments].
                          Arch Dis Child. 1993 Oct;69(4):451-3.
 REFERENCES               Plettenberg A, Stoehr A, Stellbrink HJ,
                          Albrecht H, Meigel W. A preparation from
                          bovine colostrum in the treatment of
                          HIV-positive patients with chronic diarrhea.
                          Clin Investig. 1993 Jan;71(1):42-5.
 REFERENCES               Flanigan T, Marshall R, Redman D, Kaetzel C,
                          Ungar B. In vitro screening of therapeutic
                          agents against Cryptosporidium: hyperimmune
                          cow colostrum is highly inhibitory. J
                          Protozool. 1991 Nov-Dec;38(6):225S-227S.
 REFERENCES               Nord J, Ma P, DiJohn D, Tzipori S, Tacket CO.
                          Treatment with bovine hyperimmune colostrum
                          of cryptosporidial diarrhea in AIDS patients.
                          AIDS. 1990 Jun;4(6):581-4.
 REFERENCES               Ungar BL, Ward DJ, Fayer R, Quinn CA.
                          Cessation of Cryptosporidium-associated
                          diarrhea in an acquired immunodeficiency
                          syndrome patient after treatment with
                          hyperimmune bovine colostrum.
                          Gastroenterology. 1990 Feb;98(2):486-9.
 REFERENCES               Hojlying N, Henriksen SA, Gaub J, Hjelt K,
                          Mathiesen L, Jepsen S, Ladefoged K, Tzipori
                          S. Cryptosporidium diarrhoea in AIDS patients
                          treated with hyperimmune bovine colostrum.
                          Int Conf AIDS. 1990 Jun 20-23;6(1):252
                          (abstract no. Th.B.521).
 REFERENCES               Nord J, Ma P, Tacket CO, DiJohn D, Tzipori S,
                          Sahner D, Shieb G. Treatment of AIDS
                          associated cryptosporidiosis with hyperimmune
                          colostrum from cows vaccinated with
                          cryptosporidium. Int Conf AIDS. 1989 Jun
                          4-9;5:656 (abstract no. C.586).
 REFERENCES               Ma P. Cryptosporidiosis, isosporiasis and
                          microsporidiosis. Int Conf AIDS. 1989 Jun
                          4-9;5:192 (abstract no. M.B.O.32).
 REFERENCES               Ungar B, Ward D, Fayer R, Quinn C. Successful
                          use of hyperimmune bovine colstrum to treat
                          Crptosporidium infection in an AIDS patient.
                          Int Conf AIDS. 1989 Jun 4-9;5:359 (abstract
                          no. W.B.P.45).
 ENTRY MONTH              9007
 LAST REVISION DATE       960314
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
