Dosing & Uses
Not indicated for adults
Dosage Forms & Strengths
diphtheria/tetanus toxoids/acellular pertussis adsorbed/inactivated poliovirus/Haemophilus b conjugate/hepatitis B
injectable suspension
- 0.5mL (single-dose vial)
Primary Immunization
6 weeks to <5 years
- Indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b for use as a 3-dose series in children aged 6 weeks to 4 years (prior to fifth birthday)
- 0.5 mL IM x 3 at 2, 4, 6 months
- First dose may be given as early as age 6 weeks
≥5 years
- Not approved for use
Dosing Considerations
3 doses constitute a primary immunization course against diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis
May be used to complete hepatitis B immunization series
3-dose series does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete primary series
Pertussis vaccination following Vaxelis
- Children who have received a 3-dose series of Vaxelis should complete primary and pertussis vaccination series (ie, Pentacel, Quadracel, Daptacel) according to respective prescribing information
Vaxelis may be administered in the following patients
- Used to complete first 3 doses of the 5-dose DTaP series in infants and children who have received 1 or 2 doses of Pentacel or Daptacel and are also scheduled to receive the other antigens in Vaxelis
- Infants born to HBsAg-negative mothers, and who have received a dose of any hepatitis B vaccine, prior to or at age 1 month
- Used to complete the hepatitis B vaccination series following 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
- May be administered to infants and children who have received 1 or 2 doses of H influenzae type b conjugate vaccine and who are also scheduled to receive the other antigens in Vaxelis
- Data are not available on the safety and effectiveness in such infants and children
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Irritability (≥55%)
Crying (≥45%)
Injection site pain (≥44%)
Somnolence (≥40%)
Injection site erythema (≥25%)
Decreased appetite (≥23%)
Fever ≥38°C (100.4°F) (≥19%)
Injection site swelling (≥18%)
1-10%
Vomiting (≥9%)
Postmarketing Reports
Immune system disorders: Hypersensitivity (eg, rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (eg, urticaria, angioedema, edema, face edema, shock)
General disorders and administration site conditions: Extensive swelling of injected limb (eg, swelling that involves adjacent joints)
Nervous system: Seizure, febrile seizure
Warnings
Contraindications
Hypersensitivity to any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H influenzae type b vaccine
History of encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine
History of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, until a treatment regimen is established and condition has stabilized
Cautions
Epinephrine HCl solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs
Patients who develop Guillain-Barre syndrome (GBS) within 6 weeks of receipt of a vaccine containing tetanus-toxoid should not receive any further doses; patients who develop GBS >6 weeks after immunization may receive subsequent doses of the vaccine
If administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained
Apnea following IM vaccination observed in some infants born prematurely; decision about when to administer an IM vaccine to an infant born prematurely should be based on consideration of the infant’s medical status and potential benefits and possible risks of vaccination
Vaccination may not protect all individuals
Sensitive tests (eg, latex agglutination kits) detected vaccine-derived polyribosylribitol phosphate (PRP) in the urine of vaccinees for ≥30 days following vaccination with Haemophilus b conjugate vaccine; urine antigen detection may not have definite diagnostic value in suspected H influenzae type b disease following vaccination
Adverse reactions following prior pertussis vaccination
If any of the following events occur after administration of a pertussis vaccine, carefully consider use of Vaxelis
- Temperature ≥40.5°C (≥105°F) within 48 hr, not attributable to another identifiable cause
- Collapse or shocklike state (hypotonic-hyporesponsive episode) within 48 hr
- Persistent, inconsolable crying lasting ≥3 hr within 48 hr
- Seizures with or without fever within 3 days
Pregnancy
Pregnancy
Not approved for use in individuals ≥5 years
No human or animal data are available to assess vaccine-associated risks in pregnancy
Lactation
Not approved for use in individuals ≥5 years
No human or animal data are available to assess the impact on milk production, its presence in breast milk, or its effects on the breastfed infant
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
Mechanism of Action
Conveys active immunity via stimulation of endogenously produced antibodies to diphtheria, tetanus, pertussis, poliovirus, hepatitis B, and Haemophilus influenzae type B
Administration
IM Administration
Before use, shake vial until a uniform, white, cloudy suspension results
Visually inspect vial for particulate matter and discoloration prior to administration
Withdraw and administer a single 0.5-mL IM dose
Infants <1 year: Preferred site of injection is anterolateral aspect of the thigh; do not inject into gluteal area
Do not mixed with any other vaccine
Storage
Vials: Store at 2-8°C (36-46°F); do not freeze
Images
Patient Handout
Formulary
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