BabyBIG (Page 5 of 5)

15 REFERENCES

  1. Cytogam® , cytomegalovirus immune globulin intravenous (human) (CMV-IGIV). 55th edition. Physician’s Desk Reference. 2001, Montvale, New Jersey: Medical Economics Company, Inc. 1861-1863.
  2. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician Desk Reference. 55th Edition, Montvale, New Jersey. Medical Economics Company, Inc., 2001:816-820.
  3. Immune globulin intravenous (human) (IGIV) Gammagard® S/D. 55th edition. Physician’s Desk Reference. 2001, Montvale, New Jersey: Medical Economics Company, Inc. 812-815.
  4. Immune globulin intravenous (human) Sandoglobulin® lyophilized preparation. In: Physician’s Desk Reference. 55th Edition, Montvale, New Jersey. Medical Economics Company, Inc., 2001:2210-2213.
  5. Perazella MA, Cayco AV. Acute renal failure and intravenous immune globulin: sucrose nephropathy in disguise? Am J Ther. 1998;5:399-403.
  6. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol. 1997;8:1788-1793.
  7. Important Drug Warning (“Dear Doctor”) letter. Center for Biologics Evaluation and Research, Food and Drug Administration; November 13 1998.
  8. Denepoux S, Eibensteiner PB, Steinberger P, Vrtala S, Visco V, Weyer A, et al. Molecular characterization of human IgG monoclonal antibodies specific for major birch pollen allergen Bet v 1. Anti-allergen IgG can enhance the anaphylactic reaction. FEBS Lett. 2000;465:36-46.
  9. Burks AW, Sampson HA, Buckley RH. Anaphylactic reactions after gamma globulin administration in patients with hypogammaglobulinemia. Detection of IgE antibodies to IgA. N Engl J Med. 1986;314:560-564.
  10. Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med. 1994;121:259-262.
  11. Kato E, Shindo S, Eto Y, Hashimoto N, Yamamoto M, Sakata Y, et al. Administration of immune globulin associated with aseptic meningitis. JAMA. 1988;259:3269-3270.
  12. Casteels-Van Daele M, Wijndaele L, Hunninck K. Intravenous immunoglobulin and acute aseptic meningitis. N Engl J Med. 1990;323:614-615.
  13. Scribner C, Kapit R, Philips E, Rickels N. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med. 1994;121:305-306.
  14. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion. 2001;41(2):264-268.
  15. Snydman DR, Werner BG, Tilney NL, Kirkman RL, Milford EL, Cho SI, et al. Final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with cytomegalovirus immune globulin: comparison of the randomized and open-label trials. Transplant Proc. 1991;23:1357-1360.
  16. Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med. 2006;354(5):462-471.
  17. Arnon SS. Creation and development of the public service orphan drug Human Botulism Immune Globulin. Pediatrics. 2007;119(4):785-789.
  18. Long SS, Gajewski JL, Brown LW, Gilligan PH. Clinical, laboratory, and environmental features of infant botulism in southeastern Pennsylvania. Pediatrics. 1985;75:935-941.
  19. Tseng-Ong L, Mitchell WG. Infant botulism: 20 years’ experience at a single institution. J Child Neurol. 2007;22(12):1333-1337.
  20. Underwood K, Rubin S, Deakers T, Newth C. Infant botulism: a 30-year experience spanning the introduction of botulism immune globulin intravenous in the intensive care unit at Childrens Hospital Los Angeles. Pediatrics. 2007;120(6):e1380-e1385.
  21. AAP Committee on Infectious Diseases. Report of the Committee on Infectious Diseases. 31st edition; ed. D.W. Kimberlin, M.T. Brady, and M.A. Jackson. 2018.
  22. Siber GR, Syndman DR. Use of immune globulins in the prevention and treatment of infections. Curr Clin Top Infect Dis. 1992;12:208-256.
  23. Berkman SA, Lee ML, Gale RP. Clinical uses of intravenous immunoglobins. Ann Intern Med. 1990;112:278-292.
  24. Safety of therapeutic immune globulin preparations with respect to transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus infection. Morb Mortal Wkly Rep. 1986;35(14):231-233.
  25. Wells MA, Wittek AE, Epstein JS, Marcus-Sekura C, Daniel S, Tankersley DL, et al. Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma. Trans. 1986;26:210-213.
  26. Horowitz B, Wiebe ME, Lippin A, Stryker MH. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion. 1985;25:516-522.
  27. Edwards CA, Piet MPJ, Chin S, Horowitz B. Tri(n-butyl) phosphate/detergent treatment of licensed therapeutic and experimental blood derivatives. Vox Sang. 1987;52:53-59.
  28. Paton JC, Lawrence AL, Steven IM. Quantitation of Clostridium botulinum organisms and toxin in feces and presence of Clostridium botulinum toxin in the serum of an infant with botulism. J Clin Microbiol. 1983;17:13-15.

16 HOW SUPPLIED/STORAGE AND HANDLING

  • NDC 68403-1100-6, 100 mg ± 20 mg lyophilized immunoglobulin single-dose vial individually packaged in a carton.
  • Store the vial containing the lyophilized product between 2° and 8°C (35.6° to 46.4°F). Do not store BabyBIG in the reconstituted state.
  • Use reconstituted BabyBIG within 2 hours.
  • Do not use beyond expiration date, and dispose unused product in accordance with local requirements.

17 PATIENT COUNSELING INFORMATION

  • Discuss the risks and benefits of BabyBIG use with the patient’s legal guardians, including the possibility of adverse reactions, e.g., hypersensitivity reactions such as anaphylaxis, as well as aseptic meningitis, TRALI, hemolysis, renal failure, and thrombosis [see WARNINGS AND PRECAUTIONS (5)].
  • Inform patient’s legal guardians that BabyBIG is made from human plasma and may contain infectious agents that can cause disease. While the risk of transmitting an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, the patient’s guardian should report any symptoms that concern them [see WARNINGS AND PRECAUTIONS (5.3)].
  • Inform patient’s legal guardians that BabyBIG may interfere with immune response to live viral vaccines (e.g., MMR) and instruct them to notify the healthcare provider of this potential interaction when the patient is to receive vaccinations [see DRUG INTERACTIONS (7) ].

For additional information concerning BabyBIG, contact:

Infant Botulism Treatment and Prevention Program
California Department of Public Health
850 Marina Bay Parkway, Room E-361
Richmond, California 94804
Telephone: 510-231-7600
US Govt. License No. 1797

Manufactured by:
Baxalta Inc.
Westlake Village, CA 91362, USA; and
Cangene bioPharma Inc.
Baltimore, MD 21230, USA

Distributed by:
FFF Enterprises
Temecula, CA 92590, USA

FFF Enterprises
Kernersville, NC 27284, USA

Distributed for:
Infant Botulism Treatment and Prevention Program
California Department of Public Health
850 Marina Bay Parkway, Room E-361
Richmond, CA 94804

Revised June 2021

PRINCIPAL DISPLAY PANEL — 2 mL Vial Label

Botulism Immune Globulin Intravenous
(Human) (BIG-IV)

BabyBIG®

DO NOT SHAKE VIAL
AFTER RECONSTITUTION;
AVOID FOAMING.
See package insert for
reconstitution, dosage, and
administration. Rx only.
Single use container.

007404

Manufactured for:
California Department of
Public Health
by: Baxalta Inc. and
Cangene bioPharma Inc.

LOTEXP.

PRINCIPAL DISPLAY PANEL -- 2 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 Single Use Vial Carton

NDC 68403-1100-7

Rx Only

100 mg IgG, 100 mg Sucrose
20 mg Albumin (Human)
Lyophilized
Solvent Detergent Treated

Botulism Immune GlobulinIntravenous (Human) (BIG-IV)

BabyBIG®

Store between 2°C and 8°C (35.6°F and 46.4°F).

PRINCIPAL DISPLAY PANEL -- 1 Single Use Vial Carton
(click image for full-size original)
BABYBIG human botulinum neurotoxin a/b immune globulin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68403-1100
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
human botulinum neurotoxin a/b immune globulin (human botulinum neurotoxin a/b immune globulin) human botulinum neurotoxin a/b immune globulin 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sucrose 50 mg in 1 mL
albumin human 10 mg in 1 mL
sodium phosphate, monobasic, anhydrous
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68403-1100-7 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (68403-1100-6)
1 NDC:68403-1100-6 2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (68403-1100-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125034 10/23/2003
Labeler — CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (004519216)
Establishment
Name Address ID/FEI Operations
Baxalta Inc. 085206634 MANUFACTURE (68403-1100)
Establishment
Name Address ID/FEI Operations
Cangene BioPharma Inc. 050783398 MANUFACTURE (68403-1100)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions 962674474 LABEL (68403-1100), PACK (68403-1100)

Revised: 06/2021 CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

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