Recent Updates:

Monograph added.

Indications for VAXELIS:

Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to H. influenzae type b in children 6 weeks through 4 years of age (prior to 5th birthday).

Adult Dosage:

Not applicable.

Children Dosage:

Each dose is 0.5mL IM, in anterolateral thigh (infants <1yr). Give as a 3 dose series at 2 months, 4 months, and 6 months of age. May give 1st dose as early as 6 weeks of age. Three doses of Vaxelis constitutes primary immunization against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis. Vaxelis may be used to complete the hepatitis B immunization series. Pertussis vaccination, previously vaccinated with ≥1 dose of individual components: see full labeling.

VAXELIS Contraindications:

Anaphylaxis associated with a previous dose or any other component. Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

VAXELIS Warnings/Precautions:

Fever (≥105°F within 48hrs), persistent inconsolable crying (lasting ≥3hrs within 48hrs), shock (within 48hrs), seizures (within 3 days) after previous pertussis vaccine. Guillain-Barre syndrome (within 6 weeks) of a previous tetanus toxoid vaccine. Immunocompromised. Risk of apnea in premature infants. Have epinephrine inj (1:1000) available.

VAXELIS Classification:

DTaP + IPV + Hib (PRP-OMP) + HB.

VAXELIS Interactions:

Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response. May interfere with urine antigen detection in suspected H. influenzae type b disease after vaccination with Vaxelis.

Adverse Reactions:

Inj site reactions (pain, erythema, swelling), irritability, crying, somnolence, decreased appetite, fever, vomiting.

Generic Drug Availability:


How Supplied:

Single-dose vials, prefilled syringes (without needles)—10