Pentacel

Vaccine Combinations with a Tetanus Component

Record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record.
If a prior Pentacel dose has been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.
Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.[52653]
The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; 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.
Fractional doses (doses less than 0.5 mL) should not be given.

Preparation
The package contains a vial of the DTaP-IPV component and a vial of lyophilized ActHIB vaccine component.
Gently shake the vial of the DTaP-IPV component, and withdraw the entire liquid content and inject into the vial of the lyophilized ActHIB vaccine component. Gently swirl the vial now containing Pentacel vaccine thoroughly until a cloudy, uniform, white to off-white (yellow tinge) suspension results. Do not administer if it appears otherwise.
Do not mix with any other vaccine.
Do not administer the vaccine if it has been frozen.
Vials are for single use only and contain no preservatives; once the single-dose vial has been penetrated, use the withdrawn vaccine promptly, and discard the vial.
 
Intramuscular Injection
A separate syringe and needle should be used for each person receiving Pentacel.
Older children: Inject into the deltoid muscle of the upper arm. Do NOT administer in the gluteal muscle.
Infants and young children 1 to 2 years: Inject into the anterolateral aspect of the mid-thigh.[63859]
Injection must be accomplished with a needle long enough to ensure IM deposition of the vaccine.
For pediatric patients 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
For children 1 to 2 years, a needle at least 1-inch long is preferred for administration into the thigh; a 5/8-inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90-degree angle.
For the majority of infants younger than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.

anaphylactoid reactions / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
cyanosis / Early / Incidence not known
seizures / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
apnea / Delayed / Incidence not known

erythema / Early / 7.1-17.3
dyspnea / Early / Incidence not known
hypotonia / Delayed / Incidence not known
encephalopathy / Delayed / Incidence not known
meningitis / Delayed / Incidence not known

irritability / Delayed / 53.5-76.9
inconsolable crying / Delayed / 35.9-59.3
injection site reaction / Rapid / 5.0-56.1
lethargy / Early / 24.1-45.8
fever / Early / 5.8-16.3
drowsiness / Early / Incidence not known
urticaria / Rapid / Incidence not known
rash / Early / Incidence not known
skin discoloration / Delayed / Incidence not known
vomiting / Early / Incidence not known
diarrhea / Early / Incidence not known
anorexia / Delayed / Incidence not known
syncope / Early / Incidence not known
rhinitis / Early / Incidence not known
pallor / Early / Incidence not known
infection / Delayed / Incidence not known
cough / Delayed / Incidence not known

Pentacel

Rx

Intramuscular vaccine
Used for protection against pertussis, tetanus, diphtheria, Haemophilus influenzae type b, and polio
Ideally given at 2, 4, 6, and 15 to 18 months

0.5 mL IM at 2, 4, 6, and 15 to 18 months of age (total of 4 doses). Four doses constitute a primary immunization course against pertussis, and three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis. 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 to 6 years of age; the recommended minimum interval between dose 1 and 2 and between dose 2 and 3 is at least 4 weeks and a minimum interval between dose 3 and 4 is 6 months. The final dose of a poliovirus vaccine series must be administered at age 4 to 6 years regardless of the number of previous doses. For example, a child who received 4 doses of Pentacel at 2, 4, 5, and 18 months of age needs an additional IPV dose at age 4 to 6 years. The minimum interval between dose 4 and 5 is 6 months.

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

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

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.

Pentacel Intramuscular Inj Pwd F/Susp
Pentacel Intramuscular Inj Susp

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

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

6 weeks to 12 months: 0.5 mL/dose IM.
younger than 6 weeks: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), and Haemophilus influenzae type b, as well as the virus that causes 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 Unit/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 Unit/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]
Inactivated poliovirus vaccine, IPV: Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce neutralizing antipoliovirus antibodies against each of the 3 poliovirus serotypes (Types 1, 2, and 3).
Haemophilus influenzae type b conjugate vaccine: The high virulence of Haemophilus influenzae type b (Hib) is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. The Hib conjugate vaccine contains the capsule polysaccharides from Hib bound to an outer membrane protein complex (OMPC) of tetanus toxoid. Hib conjugate vaccine exposure stimulates the immune system to produce Hib capsule-specific antibodies that make the organism vulnerable to antibody and cell-mediated immunity. Unconjugated capsule polysaccharide vaccines cause B-cell stimulation only; conjugation of the capsule polysaccharide also results in T-cell stimulation, which makes antibodies more persistent and more likely to be stimulated with subsequent exposure to Hib antigens.[31601] [42864]

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is administered intramuscularly.

The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; inactivated poliovirus vaccine, IPV is not approved for use in women 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; Haemophilus influenzae type B conjugate vaccine; inactivated poliovirus vaccine, IPV is not approved for use in women 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 Pentacel, 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 Pentacel is not approved for use in women of 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.