hepatitis b vaccine/haemophilus influenzae type b vaccine (Comvax, HIB/Hep B Vaccine)

Dosing and uses of Comvax, HIB/Hep B Vaccine (hepatitis b vaccine/haemophilus influenzae type b vaccine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

Not for use in adults

 

Pediatric dosage forms and strengths

HIB cap polysaccharide/N. meningitides OMPC/HBsAg

injection suspension

• (7.5 mcg/125 mcg//5mcg)/0.5 mL

 

Immunization

Preferred: 0.5 mL IM at 2, 4, & 12-15 mo (3 doses) Or

Two 0.5 mL doses at 6-wk interval, followed by 3rd dose 8-11 months after 2nd dose

May be used in infants who have received 1 dose of hep B vaccine (recombinant) at birth

 

Comvax, HIB/Hep B Vaccine (hepatitis b vaccine/haemophilus influenzae type b vaccine) adverse (side) effects

Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

 

>10%

Injection site reactions (35%)

Somnolence (21-50%)

Unusual high pitch crying (3-11%)

Fever (11-14%)

Erytherma (22-27%)

Pain/soreness (24-35%)

 

1-10%

Rash (≤1%)

Anorexia (1-4%)

Diarrhea (1-2%)

Candidiasis (≤1%)

Otitis media (<1-3%)

Congestion (≤1%)

Rhinorrhea (≤1%)

Upper respiratory tract infection (≤1%)

 

<1%

Angioedema

Febrile seizures

Thrombocytopenia

Urticaria

Erythema multiforme

 

Warnings

Contraindications

Documented hypersensitivity to any component of the product

 

Cautions

Stopper contains natural rubber latex, which some individuals may be hypersensitive to

Keep epinephrine handy in case of anaphylactic rxns

Not for H. influenzae meninigitis or sepsis

Do not give IV, SC or intradermally

Caution in Guillain-Barre syndrome within 6 wk of prior tetanus toxoid vaccine

Syncope accompanied by transient disturbances, tonic-clonic movements, or weakness reported

Consider postponing administration iin patients with moderate or severe acute illness (with or without fever)

Use caution in patients with a history of bleeding disorders (including thrombocytopenia) and or patients on anticoagulants

Use caution in severely immunocompromised patients

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Not indicated for women of childbearing age

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Comvax, HIB/Hep B Vaccine (hepatitis b vaccine/haemophilus influenzae type b vaccine)

Mechanism of action

Contains Hemophilus B capsular polysaccharide conjugated to meningococcal protein & Hepatitis B surface antigen which elicit antibody production & thereby impart immunity

Conveys active immunity via stimulation of production of endogenously produced antibodies