Pediarix

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Pediarix

Classes

Vaccine Combinations with a Tetanus Component

Administration

 
NOTE: Health care professionals administering this vaccine should take appropriate precautions to prevent allergic reactions (see Precautions).
 
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.

Injectable Administration

Pediarix is administered intramuscularly; do not give intravenously or subcutaneously.
Fractional doses (doses < 0.5 mL) should not be given.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit

Intramuscular Administration

Preparation:
Shake vial vigorously just before withdrawing dose (use aseptic technique) to ensure a uniform, cloudy suspension. If the vaccine cannot be resuspended or if a gel-like substance is present, discard it.
A separate syringe and needle should be used for each person receiving Pediarix.
Do not mix with any other vaccine.
Storage of unopened vials:
Manufacturer recommendations: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze.[48514]
Off-label storage information: According to a 2007 published article, storage of Pediarix (GlaxoSmithKline) at room temperature for up to 24 hours is acceptable.[58514] NOTE: Because changes in vaccine formulation may affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.
 
Intramuscular injection:
Before administration, clean skin over the injection site with a suitable cleansing agent.
The preferred injection sites are the anterolateral aspect of the thigh (particularly for infants) and the deltoid muscle of the upper arm (usually suitable for older children). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
When concomitant administration of other vaccines or immunoglobulin is required they should be given with different syringes and at different injection sites. In clinical trials, Pediarix and Hib conjugate vaccine were routinely concomitantly administered at separate sites. Data are also available from 2 clinical studies in which Pediarix, Hib, and 7-valent pneumococcal conjugate vaccines were concomitantly administered at separate sites.

Adverse Reactions
Severe

intussusception / Delayed / 0-1.0
apnea / Delayed / Incidence not known
seizures / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
aluminum toxicity / Delayed / Incidence not known
muscle paralysis / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
bronchospasm / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
cyanosis / Early / Incidence not known

Moderate

erythema / Early / 10.0
hypotonia / Delayed / Incidence not known
neuritis / Delayed / Incidence not known
encephalopathy / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
lymphadenopathy / Delayed / Incidence not known
dyspnea / Early / Incidence not known
hypotension / Rapid / Incidence not known
elevated hepatic enzymes / Delayed / Incidence not known

Mild

injection site reaction / Rapid / 10.0
anorexia / Delayed / 10.0
irritability / Delayed / Incidence not known
inconsolable crying / Delayed / Incidence not known
fever / Early / Incidence not known
weakness / Early / Incidence not known
hypoesthesia / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
pallor / Early / Incidence not known
insomnia / Early / Incidence not known
asthenia / Delayed / Incidence not known
malaise / Early / Incidence not known
headache / Early / Incidence not known
chills / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
urticaria / Rapid / Incidence not known
maculopapular rash / Early / Incidence not known
lethargy / Early / Incidence not known
fatigue / Early / Incidence not known
drowsiness / Early / Incidence not known
petechiae / Delayed / Incidence not known
alopecia / Delayed / Incidence not known
rash / Early / Incidence not known
restlessness / Early / Incidence not known
diarrhea / Early / Incidence not known
vomiting / Early / Incidence not known
syncope / Early / Incidence not known

Common Brand Names

Pediarix

Dea Class

Rx

Description

Pediarix™ is a combination of 5 of the 7 vaccines that are currently recommended for all children in the first 6 months of life; the DTaP component of this vaccine is the same as that found in Infanrix®; the hepatitis B vaccine component is the same as that found in Engerix-B®; the inactivated poliovirus vaccine in this product is a new formulation.

Dosage And Indications
For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, hepatitis B prophylaxis, and poliovirus prophylaxis for primary immunization. Intramuscular dosage Adults, Adolescents, and Children >= 7 years

Pertussis vaccine is not recommended in this age group. Therefore, Pediarix is not recommended. Use tetanus and diphtheria toxoid (Td) in adults for tetanus and diphtheria prophylaxis.

Infants >= 6 weeks and Children up to 7 years

Give 0.5 ml IM at intervals of 6—8 weeks (preferably 8 weeks) for 3 doses. The first dose is recommended at 2 months of age, but may be given as early as 6 weeks and up to the seventh birthday. Administer 0.5 ml IM beginning at 8 weeks of age then at 4—8 week intervals to complete a total of 3 doses. Vaccination may be initiated up to the seventh birthday. NOTE: The recommended immunization schedule from the Centers for Disease Control calls for 4 doses of an inactivated poliovirus vaccine (IPV) at 2 months of age, 4 months of age, between 6 and 18 months of age, and 4—6 years of age. The final dose of a poliovirus vaccine series must be administered at age 4 to 6 years regardless of the number of previous doses; therefore, a child who received 3 doses of Pediarix at 2, 4, and 6 months of age will need an additional IPV dose at age 4—6 years (see Poliovirus Vaccine, Inactivated, IPV monograph).

Pre-term infants >= 6 weeks

See infant dosage; pre-term infants should be vaccinated according to their chronological age from birth.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hepatitis B Immune Globulin, HBIG: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

How Supplied

Pediarix Intramuscular Inj Susp

Maximum Dosage
Adults

Do not use.

Geriatric

Do not use.

Adolescents

Do not use.

Children

>= 7 years: Do not use.
12 months up to 7 years: 0.5 mL/dose IM.

Infants

>= 6 weeks: 0.5 mL/dose IM.

Neonates

Do not use.

Mechanism Of Action

Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV (Pediarix™) confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), as well as the viruses that cause hepatitis B and polio.
 
•Diptheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP: The diphtheria toxoid, tetanus toxoid, and pertussis antigens in this product are the same as those in diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix®).
 
Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of neutralizing antibodies against the exotoxin. Infection with C. diphtheriae does not necessarily confer immunity, and previously infected individuals should still receive toxoid.
 
Exotoxin release by C. tetani causes the neuromuscular dysfunction associated with tetanus. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin. Natural immunity to C. tetani also does not occur, and patients previously infected with C. tetani should receive the tetanus toxoid.
 
Pertussis, or whooping cough, is a highly communicable disease of the respiratory tract caused by Bordetella pertussis infection. The acellular pertussis vaccine contains different pertussis antigens (e.g., filamentous hemagglutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components.
 
•Hepatitis B Vaccine, recombinant: The hepatitis B surface antigen in this product is the same as that in hepatitis B vaccine, recombinant (Engerix-B®). Immunization with hepatitis B vaccine stimulates the immune system to produce anti-hepatitis B surface antigen antibodies (anti-HBs) without exposing the patient to the risks of active infection. Many epidemiological studies indicate that patients who develop anti-HBs following infection with hepatitis B are immune to the virus upon reexposure. Infection with hepatitis D can occur only with concurrent hepatitis B infection, therefore, vaccination with recombinant hepatitis B vaccine provides protection against hepatitis D as well. Chronic hepatitis B infection has been linked to the development of hepatocellular carcinoma. Because vaccination with hepatitis B vaccine can prevent this, it is recognized as the first anti-cancer vaccine.
 
•Inactivated poliovirus vaccine, IPV: The inactivated poliovirus vaccine component in Pediarix is a new formulation that has demonstrated similar efficacy to the currently available inactivated poliovirus vaccines in the US. Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce anti-poliovirus antibodies against the each of the 3 poliovirus strains.

Pharmacokinetics

Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV (i.e., Pediarix) is administered intramuscularly. The pharmacokinetics of this vaccine are not well defined. In one study, pre-vaccination and 1 month post-third dose antibody titers were drawn for Pediarix and its separately administered components. When the immunogenicities were compared, no differences in immune response rates were found. There were, however, some quantitative differences in specific antibody titers among groups. The immunity information below is primarily based on administration of each vaccine alone.
 
Diphtheria toxoid, tetanus toxoid, pertussis vaccine (DTP): After three doses of DTP, 90% of vaccine recipients develop protective antibodies against diphtheria and tetanus. In patients receiving four doses of DTP, immunity has been shown to persist for 10 years or more. After three doses of DTP, 70—90% of recipients develop protective antibodies against B. pertussis. In patients receiving four doses of DTP, immunity has been shown to persist for 10 years or more. In those receiving four doses of DTP, immunity starts to decline 4—6 years after immunization, and fewer than 50% of recipients have protective antibodies against B. pertussis 10 years after immunization. Lifelong immunity occurs, however, most likely from subsequent B. pertussis infections.
Hepatitis B vaccine, recombinant: Studies evaluating plasma-derived hepatitis B vaccine reveal that anti-HBs appear in the serum 2 weeks after IM administration, peak within 6 months, and can remain detectable for 3—7 years.
Inactivated poliovirus vaccine (IPV): Inactivated poliovirus vaccine produces protective levels of antibody to all three serotypes of poliovirus in over 98% of recipients completing the 3 dose series. Circulating antibodies to all three types of poliovirus persist for at least 10 years. The post third dose immune response rates to the IPV component found in Pediarix were found to be not inferior to those induced by the currently licensed IPV and OPV.

Pregnancy And Lactation
Pregnancy

Pediarix is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women have not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. According to the manufacturer, use of this vaccine is not recommended in women of childbearing age. Pregnant patients who require immunization or boosters, should refer to the individual vaccine component monographs for more information.

According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Pediarix, pose no risk for nursing mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Pediarix is not approved for use in women of childbearing age; however, the individual vaccine components are and may be potential alternatives to consider during breast-feeding (see the individual monographs for more information). Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.