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HibTITER

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HibTITER

HibTITER

WARNINGS

HibTITER (diphtheria crm197 protein conjugate) WILL NOT PROTECT AGAINST H. INFLUENZAE OTHER THAN TYPE b STRAINS, NOR WILL HibTITER (diphtheria crm197 protein conjugate) PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE MENINGITIS OR SEPTIC DISEASE.

AS WITH ANY INTRAMUSCULAR INJECTION, HibTITER (diphtheria crm197 protein conjugate) SHOULD BE GIVEN WITH CAUTION TO INFANTS OR CHILDREN WITH THROMBOCYTOPENIA OR ANY COAGULATION DISORDER, OR TO THOSE RECEIVING ANTICOAGULANT THERAPY (SEE DRUG INTERACTIONS).

ANTIGENURIA HAS BEEN DETECTED FOLLOWING RECEIPT OF HAEMOPHILUS b CONJUGATE VACCINE36 AND THEREFORE ANTIGEN DETECTION IN URINE MAY NOT HAVE DIAGNOSTIC VALUE IN SUSPECTED HAEMOPHILUS b DISEASE WITHIN 2 WEEKS OF IMMUNIZATION.

The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected into persons with known or possible latex sensitivity.

PRECAUTIONS

General

  1. CARE IS TO BE TAKEN BY THE HEALTH CARE PROVIDER FOR SAFE AND EFFECTIVE USE OF THIS PRODUCT.
  2. PRIOR TO ADMINISTRATION OF ANY DOSE OF HibTITER (diphtheria crm197 protein conjugate) , THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTH CARE PROVIDER SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATION IN THE CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH HibTITER (diphtheria crm197 protein conjugate) AND TO ALLOW AN ASSESSMENT OF BENEFITS AND RISKS.
  3. BEFORE THE INJECTION OF ANY BIOLOGICAL, THE HEALTH CARE PROVIDER SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF ALLERGIC OR ANY OTHER SIDE REACTIONS. This should include: a review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1,000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
  4. Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization procedures.37,38 Deferral of administration of vaccine may be considered in individuals receiving immunosuppressive therapy.37 Other groups should receive this vaccine according to the usual recommended schedule.37–39 (See DRUG INTERACTIONS.)
  5. Minor illnesses, such as mild respiratory infection with or without low-grade fever, are not generally contraindications to vaccination. The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. The administration of HibTITER® (diphtheria crm197 protein conjugate) should be postponed in subjects suffering from acute severe febrile illness.
  6. This product is not contraindicated based on the presence of human immunodeficiency virus infection.40
  7. As reported with Haemophilus b polysaccharide vaccine, cases of Haemophilus b disease may occur prior to the onset of the protective effects of the vaccine.3,41
  8. The vaccine should not be injected intradermally, subcutaneously, or intravenously since the safety and immunogenicity of these routes have not been evaluated. The vaccine should be given intramuscularly.
  9. A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
  10. Special care should be taken to prevent injection into a blood vessel.
  11. The vaccine is to be administered immediately after being drawn up into a syringe. Single dose 0.5 mL vial contains no preservative. Use one dose per vial; do not re-enter vial. Discard unused portions.
  12. As with any vaccine, HibTITER® (diphtheria crm197 protein conjugate) may not protect 100% of individuals receiving the vaccine.

ALTHOUGH SOME ANTIBODY RESPONSE TO DIPHTHERIA TOXIN OCCURS, IMMUNIZATION WITH HibTITER (diphtheria crm197 protein conjugate) DOES NOT SUBSTITUTE FOR ROUTINE DIPHTHERIA IMMUNIZATION.

The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected into persons with known or possible latex sensitivity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

HibTITER (diphtheria crm197 protein conjugate) has not been evaluated for its carcinogenic, mutagenic potential, or impairment of fertility.

Pregnancy

Reproductive Studies — Pregnancy Category C

Animal reproduction studies have not been conducted with HibTITER (diphtheria crm197 protein conjugate) . It is also not known whether HibTITER (diphtheria crm197 protein conjugate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. HibTITER (diphtheria crm197 protein conjugate) is NOT recommended for use in a pregnant woman.

Geriatric Use

This vaccine is NOT recommended for use in adult populations.

Pediatric Use

The safety and effectiveness of HibTITER (diphtheria crm197 protein conjugate) in children below the age of 6 weeks have not been established.

REFERENCES

3. Wenger JD, Ward JL, Broome CV. Prevention of Haemophilus influenzae type b disease: vaccines and passive prophylaxis. In: Remington JS, Swartz MS, eds. Current Clinical Topics in Infectious Diseases. New York, NY: McGraw-Hill Inc; 1989;10: 306-339.

20. Unpublished data available from Lederle Laboratories.

30. Black SB, Shinefield HR, Lampert D, et al. Safety and immunogenicity of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in infancy. Pediatr Infect Dis J. 1991;10:92-96

32. Recommendations of the AAP: Haemophilus influenzae type b conjugate vaccines: recommendations for immunization of infants and children 2 months of age and older: update. Pediatrics. 1991;88:169-172.

33. Recommendation of the ACIP: Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR. 1991;40:1-7.

34. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR. 2002;51(No. RR-2);1-36.

35. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000: 26, 266-72.

36. Jones RG, Bass JW, Weisse ME, et al. Antigenuria after immunization with Haemophilus influenzae oligosaccharide CRM197 conjugate (HbOC) vaccine. Pediatr Infect Dis J. 1991;10:557-559.

37. American Academy of Pediatrics: Report of the Committee on Infectious Diseases. 22nd ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1991.

38. Recommendation of the ACIP: Immunization of children infected with human T-lymphotrophic virus type III/lymphadenopathy-associated virus. MMWR. 1986;35(38):595-606.

39. Immunization of children infected with human immunodeficiency virus – supplementary ACIP statement. MMWR. 1988;37(12):181-183.

40. General Recommendations on Immunization: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 1989;38(13):221.

41. Spinola SM, Sheaffer CI, Philbrick KB, et al. Antigenuria after Haemophilus influenzae type b polysaccharide immunization: a prospective study. J Pediatr. 1986;109:835-837.

42. CDC. Vaccine Adverse Event Reporting System – United States. MMWR. 1990;39:730-733.

43. Paradiso PR. Combined childhood immunizations. JAMA. 1992;268:1685.

44. Paradiso PR, Hogerman DA, Madore DV, et al. Safety and immunogenicity of a combined diphtheria, tetanus, pertussis and Haemophilus influenzae type b vaccine in young infants. Pediatrics. 1993;92(6):827-32.

45. Wyeth Pharmaceuticals, Data on File: Prevnar Study D118-P12.

46. Wyeth Pharmaceuticals, Data on File: Prevnar Study D118-P16.

47. Wyeth Pharmaceuticals, Data on File: Prevnar Study D118-P7.

48. Shinefield H, Black S, Ray P, et al. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 1999;18:757-63.

49. Wyeth Pharmaceuticals, Data on File: Prevnar Study D118-P3.

50. Rennels MB, Edwards KM, Keyserling HL, et al. Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants. Pediatrics. 1998;101(4):604-11.

51. Wyeth Pharmaceuticals, Data on File: Prevnar Study D118-P8.

52. Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:187-95.

53. Milstein JB, Gross TP, Kuritsky JN. Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after one year of marketing. Pediatrics. 1987;80:270-274.

54. D'Cruz DF, Shapiro ED, Spiegelman KN, et al. Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome) after immunization with Haemophilus influenzae type b conjugate vaccine. J Pediatr. 1989;115:743-746.

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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