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Haemophilus b Conjugate and Hepatitis B Vaccine

Pronunciation

(he MOF i lus bee KON joo gate & hep a TYE tis bee vak SEEN)

Index Terms

  • Haemophilus Influenzae
  • Hepatitis B
  • HepB
  • HepB-Hib
  • Hib
  • Hib-HepB

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, suspension [preservative free]:

Comvax®: Haemophilus b capsular polysaccharide 7.5 mcg (bound to Neisseria meningitides OMPC 125 mcg) and hepatitis B surface antigen 5 mcg per 0.5 mL (0.5 mL) [contains aluminum; contains natural rubber/natural latex in packaging]

Brand Names: U.S.

  • Comvax

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)
  • Vaccine, Inactivated (Viral)

Pharmacology

See individual agents.

Use: Labeled Indications

Haemophilus b and Hepatitis B disease prevention: Active immunization against invasive disease caused by H. influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age born of hepatitis B surface antigen (HBsAg)-negative mothers

Infants born of HBsAg-positive mothers or mothers of unknown HBsAg status should receive hepatitis B vaccine (recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (refer to current ACIP recommendations).

Contraindications

Hypersensitivity to Haemophilus b vaccine, hepatitis B vaccine, yeast, or to any component of the formulation

Dosing: Pediatric

Immunization: Infants: IM: 0.5 mL/dose; one dose at 2, 4, and 12-15 months of age (total of 3 doses). Note: If the recommended schedule cannot be followed, the interval between the first two doses should be at least 6 weeks and the interval between the second and third dose should be as close as possible to 8-11 months. Minimum age for first dose is 6 weeks.

Modified Schedule: Children who receive one dose of hepatitis B vaccine at or shortly after birth may receive Comvax® on a schedule of 2, 4, and 12-15 months of age

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Shake well prior to use. Administer 0.5 mL IM into anterolateral thigh [data suggests that injections given in the buttocks frequently are given into fatty tissue instead of into muscle and result in lower seroconversion rates]; do not administer intravenously, intradermally, or subcutaneously. US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered with by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (NCIRD/ACIP 2011).

Storage

Store at 2°C to 8°C (36°F to 48°F); do not freeze.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Irritability (32% to 57%), drowsiness (21% to 50%), abnormal crying (unusual/high pitched: 3% to 11%)

Local: Injection site reactions: Local soreness/soreness at injection site (≤35%), pain at injection site (≤35%), induration at injection site (≥1 inch: ≤30%), swelling at injection site (≥1 inch: ≤30%), erythema at injection site (≥1 inch: 22% to 27%)

Miscellaneous: Fever (101°F to 102.9°F: 11% to 14%; ≥103°F: ≤3%)

1% to 10%:

Dermatologic: Skin rash (≤1%)

Gastrointestinal: Anorexia (≤4%), vomiting (1% to 3%), diarrhea (≤2%), oral candidiasis (≤1%)

Otic: Otitis media (≤3%)

Respiratory: Cough (≤1%), respiratory congestion (≤1%), rhinorrhea (≤1%), upper respiratory tract infection (≤1%)

Miscellaneous: Crying (≤2%)

<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, erythema multiforme, febrile seizures, seizure, thrombocytopenia, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high dose corticosteroids]); may have a reduced response to vaccination. May be used in patients with HIV infection. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

Dosage form specific issues:

• Latex: Packaging contains natural latex rubber.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Comvax is not indicated for use as the “birth dose” of hepatitis B vaccine; hepatitis B vaccine (recombinant) is indicated for all infants at birth. This combination vaccine cannot be administered to any infant <6 weeks of age or >71 months of age. Infants born of HBsAg-positive mothers or mothers of unknown HBsAg status should receive hepatitis B vaccine (recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (refer to current ACIP recommendations). Infants born of HBsAg-positive mothers should also receive hepatitis B immune globulin at birth.

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011). Infection may occur within the week of vaccination, prior to the onset of the vaccine.

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. This product is not indicated for use in women of childbearing age.

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, irritability, abnormal crying, or injection site pain, edema, or irritation. Have patient report immediately to prescriber high fever (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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