Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine (see CONTRAINDICATIONS).

General

General care is to be taken by the health-care provider for the safe and effective use of this product.

As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

As reported with Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate Vaccine, cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.

The packaging stopper of this product contains natural rubber latex which may cause allergic reactions.

Instructions to Health-care Provider

The health-care provider should determine the current health status and previous vaccination history of the vaccinee.

The health-care provider should question the patient, parent or guardian about reactions to a previous dose of COMVAX, PedvaxHIB or other Haemophilus b conjugate vaccines or RECOMBIVAX HB or other hepatitis B vaccines.

Injection of a blood vessel should be avoided.

COMVAX should be given with caution in infants with bleeding disorders such as hemophilia or thrombocytopenia, with steps taken to avoid the risk of hematoma following the injection.

If COMVAX is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

COMVAX is not contraindicated in the presence of HIV infection.⁶⁸

Laboratory Test Interactions

Sensitive tests (e.g., Latex Agglutination Kits) may detect PRP derived from the vaccine in the urine of some vaccinees for at least 30 days following vaccination with lyophilized PedvaxHIB⁵⁸; in clinical studies with lyophilized PedvaxHIB, such children demonstrated a normal immune response to the vaccine. It is not known whether antigenuria will occur after vaccination with COMVAX.

Carcinogenesis, Mutagenesis, Impairment of Fertility

COMVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with COMVAX. It is also not known whether COMVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. COMVAX is not recommended for use in women of childbearing age.

Pediatric Use

Safety and effectiveness of COMVAX in infants below the age of 6 weeks and above the age of 15 months have not been established. However, studies have demonstrated that PedvaxHIB is safe and immunogenic when administered to infants and children up to the age of 71 months and RECOMBIVAX HB is safe and immunogenic in persons of all ages.

COMVAX should not be used in infants younger than 6 weeks of age because this will lead to a reduced anti-PRP response and may lead to immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen).^59-61

Infants born to HBsAg-positive mothers should not receive COMVAX but instead should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]). (See DOSAGE AND ADMINISTRATION.)

Geriatric Use

This vaccine is NOT recommended for use in adult populations.

REFERENCES

58. Goep, J.G., et al. Pediatr Infect Dis J 1(1): 2-5, 1992.

59. Keyserling, H.L., et al. Program and Abstracts of the 30th ICAAC, 1990. (Abst. 63).

60. Ward, J.I., et al. Program and Abstracts of the 32nd ICAAC, 1992. (Abst. 984).

61. Lieberman, J.M., et al. Infect Dis, 199 (Abst.1028).

68. Centers for Disease Control. MMWR 42(RR-4): 1-18, April 9, 1993.

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