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Note: Not approved in the US
Active primary immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b in infants and children 6 weeks to 2 years of age; booster immunization (at 18 months) in infants who previously received a full primary vaccination course of each component of the vaccine
Hypersensitivity to any component of vaccine or formulation; encephalopathy of unknown etiology within 1 week following prior vaccination with a pertussis-containing vaccine; moderate or severe acute febrile illness or acute infection; children >7 years of age
Note: Vaccinate preterm infants according to their chronological age from birth. Children 6 weeks to 2 years:
Primary immunization: IM: 0.5 mL; repeat in 8-week intervals for a total of 3 doses. Vaccination usually begins at 2 months, but may be started at 6 weeks of age. Do not administer to infants <6 weeks of age.
Use in children previously vaccinated with one or more doses of hepatitis B vaccine: Children who received 1 dose of hepatitis B vaccine at birth may receive a 3 dose series of Infanrix Hexa ¢ „ ¢ beginning no earlier than at 6 weeks of age. Use in infants who received more than 1 dose of hepatitis B vaccine has not been studied.
Where immunization against poliovirus is desired, Infanrix Hexa ¢ „ ¢ may be administered instead to infants scheduled to receive concurrent Infanrix ¢ „ ¢ (diphtheria, tetanus and acellular pertussis vaccine) and hepatitis B vaccine.
Booster immunization: IM: 0.5 mL administered at 18 months (in infants who have received a full primary vaccination course of each component of Infanrix Hexa ¢ „ ¢)
Note: Dosing delays should not interfere with the final immunity achieved with Infanrix Hexa ¢ „ ¢. Regardless of the time that elapses between doses, it is not necessary to restart the vaccination series.
Allow vial containing the Hib pellet to stay at room temperature for at least 5 minutes. Shake Pediarix ¢ „ ¢ syringe until homogenous turbid white suspension is obtained. Add entire contents of syringe to vial containing the Hib pellet and then shake vial until pellet dissolves completely. Resulting suspension will appear slightly cloudier than suspension added from syringe.
Administer by IM injection only, preferably in the anterolateral aspects of the thigh or the deltoid muscle of the upper arm. Do not administer intravenously or subcutaneously. Do not inject into the gluteal area (suboptimal hepatitis B immune response) or areas where major nerve trunks may be located. Fractional dosing (use of reduced volume) is not recommended. If more than one vaccine is to be given by IM injection use separate limbs. Rotate injection sites when completing vaccination series.
Acetaminophen may be used when needed to provide comfort; however, routine prophylactic administration of acetaminophen to prevent fever due to vaccine use is not recommended. There is evidence of a decreased immune response to some vaccines associated with acetaminophen administration; the clinical significance of this reduction in immune response has not been established.
Store at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F); do not freeze (discard if frozen). Immediate use after reconstitution is recommended; however, after reconstitution vaccine may be stored for 8 hours at ~21 ‚ °C (~70 ‚ °F).
Do not mix with other vaccines.
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
Meningococcal Polysaccharide (Groups A / C / Y and W-135) Tetanus Toxoid Conjugate Vaccine: May diminish the therapeutic effect of Tetanus Toxoids Vaccines. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) tetanus toxoid conjugate vaccine either together with or at least one month before a tetanus toxoids-containing vaccine. Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Signs/symptoms of hypersensitivity for 30 minutes after administration; respiratory function for 2-3 days following vaccination of infants born prematurely. Monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Haemophilus Influenzae type b (Hib) capsular antigen may be present in urine within 1-2 weeks following vaccination; alternative diagnostic tests should be employed in suspected Hib disease during this time.
All serious adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).
Frequency not always defined. *Incidence not specifically defined, but reported in the range of 1% to 10%.
>10%:
Central nervous system: Irritability (83%), hypersomnia (63%), sleep disorder (sleeping decreased: 51%), abnormal crying (43%), fatigue, restlessness
Gastrointestinal: Anorexia (49%), diarrhea (36%), vomiting (25%)
Local: Erythema at injection site (49%), pain at injection site (43%), swelling at injection site (36%)
Miscellaneous: Fever ( ≥38 ‚ °C [100.4 ‚ °F]: 56%; >39.5 ‚ °C [103.1 ‚ °F]*)
1% to 10%:
Central nervous system: Nervousness
Local: Induration at injection site
<1% (Limited to important or life-threatening): Angioedema, apnea, bronchospasm, cellulitis (inflammatory cellulitis without bacterial infection), collapse, edema (diffuse edema of injected limb), hypersensitivity reaction (including anaphylactoid reaction and anaphylaxis), hypotonic/hyporesponsive episode, lymphadenopathy, seizure (including febrile seizure), thrombocytopenia
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.
- Apnea: Apnea has been reported following IM vaccine administration in premature infants; consider respiratory monitoring for 2-3 days following administration and/or consider risk versus benefit in infants born prematurely.
- Reactions from previous dose: Carefully consider use in patients with history of any of the following effects from previous administration of whole-cell DTP or acellular pertussis vaccine: Fever ≥105 ‚ °F (40.5 ‚ °C) within 48 hours of unknown cause; seizures with or without fever occurring within 3 days; persistent, inconsolable crying episodes lasting ≥3 hours and occurring within 48 hours; shock or collapse within 48 hours.
- Syncope: Syncope has been reported with use of injectable vaccines and may be accompanied by transient visual disturbances, weakness, or tonic-clonic movements. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs.
Disease-related concerns:
- Acute illness: Use is contraindicated in patients with moderate or severe acute illness (with or without fever); may administer to patients with mild acute illness (with or without fever).
- 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.
- Guillain-Barre syndrome: The National Advisory Committee on Immunization (NACI) recommends using caution with repeat administration of any vaccine associated with the onset of Guillain-Barre syndrome within 8 weeks of immunization.
- Hepatitis B: Use for completion of hepatitis B vaccination series in infants born to HBsAG-positive mothers and previously vaccinated with hepatitis B immune globulin or born to mothers of unknown status, has not been evaluated.
- Neurologic disorders: Use with caution in patients with personal or immediate family (parent, sibling) history of progressive neurologic disease, or conditions predisposing to seizures; where appropriate, consider deferring immunization until health status can be assessed and condition stabilized. Antipyretics may be considered at the time of and for 24 hours following vaccination to patients at high risk for seizures to reduce the possibility of postvaccination fever (may occur within 2-3 days).
- Poliomyelitis: Defer administration during outbreaks of poliomyelitis.
Concurrent drug therapy issues:
- Vaccines: In order to maximize vaccination rates, the NACI recommends simultaneous administration 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.
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, inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (Rubin, 2014).
- Premature infants: May be administered to infants born prematurely beginning at chronological age of 6 weeks; decreased immune response may be observed and the degree of clinical protection is unknown. Infants born ≤28 weeks gestation may be at greater risk for apnea; monitor respiratory function closely for 2-3 days following vaccination, particularly with history of respiratory immaturity.
Dosage form specific issues:
- Aluminum: Formulation may contain aluminum.
- Neomycin: Formulation may contain neomycin.
- Polymyxin B: Formulation may contain polymyxin B.
- Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer 's labeling.
Other warnings/precautions:
- 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 (CDC, 2011).
Not indicated for use in pregnant women.
Promotes active immunity to diphtheria, tetanus, pertussis, hepatitis B, poliovirus (types 1, 2, and 3), and Haemophilus influenzae type B by inducing production of specific antibodies and antitoxins.
Immune response observed to all components 1 month following the 3-dose series
- Discuss specific use of vaccine and side effects with caregiver 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 nausea, vomiting, diarrhea, loss of strength and energy, injection site irritation or pain, irritability, or lack of appetite. Have caregiver report immediately to prescriber confusion, high fever, seizures, difficulty breathing, passing out, burning or numbness feeling, severe fatigue, abnormal crying, or abnormal movements (HCAHPS).
- Educate caregiver 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. Caregiver 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 healthcare 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.