Vaxelis

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vaxelis Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids + acellular pertussis + inactivated poliovirus + Haemophilus b conjugate + hepatitis B vaccine; per 0.5mL; susp for IM inj; preservative-free; contains aluminum, polysorbate 80, and residual amounts of formaldehyde, glutaraldehyde, bovine serum albumin, yeast protein, neomycin, streptomycin, polymyxin B, ammonium thiocyanate.

    Pharmacological Class

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

    How Supplied

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

    Storage

    • Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Protect from light. Do not use after expiration date shown on the label. 

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Mechanism of Action

    Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C. diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. Antitoxin levels of ≥0.1 IU/mL are generally regarded as protective. Levels of 1.0 IU/mL have been associated with long-term protection.
    Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C. tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A tetanus antitoxoid level ≥0.1 IU/mL as measured by the ELISA used in clinical studies of Vaxelis is considered protective.
    Pertussis (whooping cough) is a respiratory disease caused by B. pertussis. This Gram-negative coccobacillus produces a variety of biologically active omponents, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.
    Polioviruses, of which there are 3 serotypes (Types 1, 2, and 3), are enteroviruses. The presence of poliovirus type-specific neutralizing antibodies has been correlated with protection against poliomyelitis.
    Hepatitis B virus is one of several hepatitis viruses that cause systemic infection, with major pathology in the liver. Antibody concentrations of ≥10 mIU/mL against HBsAg correlate with protection against hepatitis B virus infection.
    H. influenzae type b can cause invasive disease such as meningitis and sepsis. Anti-PRP antibody has been shown to correlate with protection against invasive disease due to H. influenzae type b. Data from an efficacy study with H. influenzae type b polysaccharide vaccine in Finland indicate that an anti-PRP level of ≥1.0 mcg/mL 3 weeks after vaccination predicts protection through a subsequent 1-year period. These levels have been used to evaluate the effectiveness of H. influenzae type b conjugate vaccines, including the PRP-OMPC component of Vaxelis.

    Vaxelis Indications

    Indications

    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).

    Vaxelis Dosage and Administration

    Adult

    Not applicable.

    Children

    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.

    Children

    Vaccination Schedule

    • Each dose is 0.5 mL IM. For infants younger than 1 year, the anterolateral aspect of the thigh is the preferred site of administration. 

    • 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.

    • 3 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. 

    • A 3-dose series of Vaxelis does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

    Pertussis Vaccination following Vaxelis 

    • After receiving a 3-dose series of Vaxelis, complete the primary and pertussis vaccination series with Pentacel, Quadracel, or Daptacel.

    Administration of Vaxelis following previous doses of other DTaP-containing Vaccines

    • May use Vaxelis to complete the first 3 doses of the 5-dose DTaP series in infants and children who have received 1 or 2 doses of Pentacel or Daptacel

    Administration of Vaxelis following previous doses of any Hepatitis B Vaccine

    • May administer a 3-dose series of Vaxelis to infants born to HBsAg-negative mothers, and who have received a dose of any hepatitis B vaccine, prior to or at 1 month of age.

    • May use Vaxelis to complete the hepatitis B vaccination series after 1 or 2 doses of other hepatitis B vaccines, in infants and children born of HBsAg-negative mothers and who are also scheduled to receive the other antigens in Vaxelis.

    Administration of Vaxelis following previous doses of Inactivated Polio Vaccine (IPV) 

    • May administer Vaxelis to infants and children who have received 1 or 2 doses of H. influenzae type b Conjugate Vaccine and are also scheduled to receive the other antigens in Vaxelis.

    Vaxelis Contraindications

    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).

    Contraindications

    Hypersensitivity

    • Do not administer Vaxelis if a history of severe allergic reaction (eg, anaphylaxis) associated with a previous dose of Vaxelis or any other diphtheria toxoid, tetanus toxoi-, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.

    Encephalopathy

    • Do not administer Vaxelis if a history of encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.

    Progressive Neurologic Disorder

    • Do not administer Vaxelis if a history of progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy) until a treatment regimen has been established and the condition has stabilized.

    Vaxelis Boxed Warnings

    Not Applicable

    Vaxelis Warnings/Precautions

    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.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have epinephrine (1:1000) and other appropriate agents immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.

    • Review the patient’s immunization history for hypersensitivity prior to administration.

    Adverse Reactions following Prior Pertussis Vaccination

    • Carefully consider the potential benefits and possible risks of administering Vaxelis if any of the following events occur after administration of a pertussis vaccine:

      • Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause. 

      • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours. 

      • Persistent, inconsolable crying lasting at least 3 hours within 48 hours. 

      • Seizures with or without fever within 3 days.

    Guillain-Barré Syndrome and Brachial Neuritis 

    • Increased risk for Guillain-Barré Syndrome (GBS) after administering Vaxelis if GBS occurred within 6 weeks of a previous vaccine containing tetanus toxoid. 

    Altered Immunocompetence

    • May get suboptimal immune response when Vaxelis is administered to immunocompromised persons, including persons receiving immunosuppressive therapy.

    Apnea in Premature Infants

    • Risk of apnea has been observed in some infants born prematurely.

    • Consider the individual infant’s medical status and the potential benefits and risks of vaccination when deciding to administer Vaxelis to infants born prematurely.

    Limitations of Vaccine Effectiveness

    • May not protect all individuals.

    Interference with Laboratory Tests

    • May interfere with urine antigen detection in suspected H. influenzae type b disease after vaccination with Vaxelis.

    Pregnancy Considerations

    • Not approved for use in individuals 5 years of age and older.

    Nursing Mother Considerations

    • Not approved for use in individuals 5 years of age and older.

    Pediatric Considerations

    • Safety and efficacy of Vaelis in infants less than 6 weeks of age and adolescents 5 through 17 years of age have not been established.

    Vaxelis Pharmacokinetics

    See Literature

    Vaxelis Interactions

    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.

    Vaxelis Adverse Reactions

    Adverse Reactions

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

    Vaxelis Clinical Trials

    Clinical Trials

    Effectiveness of Vaxelis

    • The effectiveness of Vaxelis is based on the immunogenicity of the individual antigens compared to US licensed vaccines.

    Immunogenicity – US Study 005

    • Infants were randomly assigned to receive 3 doses of Vaxelis at 2, 4, and 6 months of age and Daptacel and PedvaxHIB at 15 months of age, or Control group vaccines (3 doses of Pentacel vaccine at 2, 4, and 6 months of age + Recombivax HB at 2 and 6 months of age and Daptacel and ActHIB at 15 months of age). All subjects received concomitant vaccines: RotaTeq at 2, 4 and 6 months and Prevnar 13 at 2, 4, 6, and 15 months of age.

    • Vaxelis was non-inferior to Pentacel + Recombivax HB administered concomitantly at separate sites, as demonstrated by the proportions of participants achieving seroprotective levels of antibodies to diphtheria, tetanus, poliovirus, hepatitis B and PRP antigens, and pertussis vaccine response rates and GMCs (except FHA), following 3 doses of the vaccine. 

    • To complete the 4-dose pertussis primary vaccination series, participants in both groups received Daptacel at 15 months of age and were evaluated for immune responses to pertussis antigens one month later. The non-inferiority criteria for vaccine response rates and GMCs for all pertussis antigens were met following the fourth dose.

    Concomitantly Administered Vaccines – US Study 006

    • In Study 006 conducted in the US (Table 1), the immune responses to Prevnar 13 were measured one month after the third dose. Non-inferiority criteria were met for GMCs to 12 of the 13 serotype antigens in Prevnar 13 for participants who received Vaxelis relative to Control vaccines. For serotype 6B, the non-inferiority criterion was not met (lower bound of 2-sided 95% CI for GMC ratio [Vaxelis group/Control vaccines group] is 0.64, which is below the non-inferiority criterion >0.67). 

    Vaxelis Note

    Not Applicable

    Vaxelis Patient Counseling

    Patient Counseling

    Inform the parent or guardian of the following: 

    • The potential benefits and risks of immunization with Vaxelis. 

    • The common adverse reactions that have occurred following administration of Vaxelis or other vaccines containing similar ingredients. 

    • Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.

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