Quadracel

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Quadracel

Classes

Vaccine Combinations with a Tetanus Component

Administration

Inform the patient or parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. This action is required by the National Childhood Vaccine Injury Act of 1986.
Record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine in the patient's permanent record. These actions are required by the National Childhood Vaccine Injury Act of 1986.[52653]
Epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis should be immediately available in the event of a serious allergic reaction to the vaccine.

Injectable Administration

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is administered intramuscularly; do not give intravenously or subcutaneously.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intramuscular Administration

Use vaccine as supplied; reconstitution is not necessary.
Prior to use, shake the vial or prefilled syringe vigorously to obtain a uniform white suspension.
Do not mix with any other vaccine.
A separate syringe and needle should be used for each person receiving a vaccine.
Vials and prefilled syringes are for single use only and contain no preservatives; discard any unused portion.
 
Intramuscular Injection
Quadracel vial: Use a sterile syringe and needle to withdraw suspension from vial.
Kinrix/Quadracel prefilled syringe: Attach a sterile needle to the prefilled syringe.
Inject into the deltoid muscle of the upper arm.

Adverse Reactions
Severe

Guillain-Barre syndrome / Delayed / 0-1.0
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
cyanosis / Early / Incidence not known
myocarditis / Delayed / Incidence not known
apnea / Delayed / Incidence not known
seizures / Delayed / Incidence not known
muscle paralysis / Delayed / Incidence not known
myelitis / Delayed / Incidence not known

Moderate

erythema / Early / 36.6-59.1
encephalopathy / Delayed / 0-1.0
lymphadenopathy / Delayed / Incidence not known
hypotension / Rapid / Incidence not known
dyspnea / Early / Incidence not known
hypotonia / Delayed / Incidence not known
neuritis / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
edema / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known

Mild

myalgia / Early / 53.8-53.8
injection site reaction / Rapid / 26.0-40.2
malaise / Early / 35.0-35.0
drowsiness / Early / 19.1-19.1
fever / Early / 6.0-16.0
headache / Early / 15.6-15.6
anorexia / Delayed / 15.5-15.5
pruritus / Rapid / Incidence not known
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known
arthralgia / Delayed / Incidence not known
chills / Rapid / Incidence not known
lethargy / Early / Incidence not known
maculopapular rash / Early / Incidence not known
pallor / Early / Incidence not known
inconsolable crying / Delayed / Incidence not known
irritability / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
hypoesthesia / Delayed / Incidence not known
weakness / Early / Incidence not known
nausea / Early / Incidence not known
vomiting / Early / Incidence not known
diarrhea / Early / Incidence not known
syncope / Early / Incidence not known

Common Brand Names

Kinrix, Quadracel

Dea Class

Rx

Description

Intramuscular combination vaccine
Used for immunization against diphtheria, tetanus, pertussis, and polio
Approved for use in children 4 to 6 years of age

Dosage And Indications
For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, and poliovirus prophylaxis. Intramuscular dosage Children 4 to 6 years

0.5 mL IM as a single dose.

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.
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

Corynebacterium Diphtheriae Toxoid antigen (Formaldehyde inactivated), Clostridium Tetani Toxoid antigen (Formaldehyde inactivated), Bordetella Pertussis Toxoid antigen (Glutaraldehyde inactivated) , Bordetella Pertussis Filamentous Hemagglutinin antigen (Formaldehyde inactivated), Bordetella Pertussis Pertactin antigen, Bordetella Pertussis Fimbriae 2/3 antigen, Poliovirus Type 1 antigen (Formaldehyde inactivated), Poliovirus Type 2 antigen (Formaldehyde inactivated), Poliovirus Type 3 antigen (Formaldehyde inactivated)/Kinrix/Quadracel Intramuscular Inj Susp

Maximum Dosage
Adults

Safety and efficacy have not been established.

Geriatric

Safety and efficacy have not been established.

Adolescents

Safety and efficacy have not been established.

Children

6 to 12 years: Safety and efficacy have not been established.
4 to 6 years: 0.5 mL/dose IM.
1 to 4 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), and polio.
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP: 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. A serum diphtheria antitoxin concentration of at least 0.1 International Units/mL is considered protective. Exotoxin release by Clostridium tetani causes the neuromuscular dysfunction associated with tetanus. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin. A serum tetanus antitoxin concentration of at least 0.1 International Units/mL is considered protective. 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. A serological concentration indicative of protection against pertussis has not been established.[48514] [63859]
Inactivated poliovirus vaccine, IPV: Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce neutralizing anti-poliovirus antibodies against each of the 3 poliovirus serotypes (Types 1, 2, and 3).[63859]

Pharmacokinetics

Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV is administered intramuscularly.

Intramuscular Route

Kinrix
One month after administration of Kinrix (n = 787 to 851) to pediatric patients 4 to 6 years of age, patient responses to Kinrix were compared to responses to the administration of Infanrix and IPV (n = 237 to 262) administered as separate injections. The primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs); Kinrix was found to be non-inferior to the 2 separate injections in terms of booster responses to DTaP antigens and post-vaccination GMTs for anti-poliovirus antibodies. The following antibody responses were demonstrated: anti-diphtheria toxoid 0.1 International Units/mL or greater (100 % vs. 100% for all), anti-tetanus toxoid 0.1 International Units/mL or greater (100% vs. 100% for all), anti-pertussis response of 5 ELISA units/mL or greater in seronegative infants or at least maintenance of pre-vaccination concentration in seropositive infants (anti-PT [92.2% Kinrix vs. 92.6% Infanrix + IPV], anti-FHA [95.4% vs. 96.2%], and anti-pertactin [97.8% vs. 96.9%]), anti-polio Type 1 neutralizing antibody titer 1:8 or greater (99.9% vs. 100%), and anti-polio Types 2 and 3 neutralizing antibody titer 1:8 or greater (100% vs. 100% all). Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus (Type 1, 2, and 3) were measured 1 month after administration of Kinrix with either MMR vaccine (n = 237) or MMRV vaccine (n = 239) in children 4 to 6 years of age. Booster responses after Kinrix administration with MMRV vaccine were non-inferior to immune responses after concomitant administration of Kinrix with MMR vaccine.
Quadracel
The immunogenicity of Quadracel (n = 253 to 262) was evaluated in pediatric patients aged 4 to 6 years who received the vaccine as the fifth dose in the diphtheria, tetanus, and pertussis vaccination series and the fourth or fifth dose in the inactivated poliovirus vaccination series, with comparison to individual vaccine components (administered as Daptacel + IPOL; n = 248 to 253). At 28 days after the last dose, immune responses to pertussis antigens (including pertussis toxin (PT), pertactin, and filamentous hemagglutinin (FHA)), diphtheria, tetanus, and poliovirus were non-inferior to those of the individual vaccine components. The following antibody responses were demonstrated: anti-diphtheria toxoid 0.1 International Units/mL or greater (100% Quadracel vs. 99.6% Daptacel + IPOL), anti-tetanus toxoid 0.1 International Units/mL or greater (100% vs. 99.2%), anti-PT booster response (95.2% vs. 89.9%), anti-FHA booster response (94.9% vs. 87.5%), anti-pertactin booster response (96.9% vs. 93.1%), anti-FIM booster response (97.2% vs. 92.4%), anti-polio Type 1 neutralizing antibody titer 1:8 or greater (100% vs. 99.6%), and anti-polio Types 2 and 3 neutralizing antibody titer 1:8 or greater (100% vs. 100% all). Booster response rates in both groups were similar.

Pregnancy And Lactation
Pregnancy

The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is not approved for use in individuals of childbearing age. Therefore, no data are available to assess vaccine-associated pregnancy risks.  According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women has 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.

The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is not approved for use in individuals of childbearing age. Therefore, no data are available on its use during breast-feeding to assess the impact of the vaccine on milk production, its presence in breast milk, or its effects on the breastfed infant.  According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Kinrix and Quadracel, 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. While Kinrix and Quadracel are not approved for use during childbearing age, the individual vaccine components are and may be potential alternatives to consider during breast-feeding. 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.