IPOL

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IPOL

Classes

Poliovirus Vaccines

Administration

For storage information, see specific product information within the How Supplied section.
 
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. Screen all potential vaccine recipients for a prior severe reaction to the IPV. Do not give the IPV to anyone with a past severe reaction to the vaccine (see Contraindications). Pregnant patients and those with a moderate or severe illness regardless of the presence of a fever may not be appropriate vaccine recipients.
Give the required vaccine information materials (VIMs) and inform the patient, guardian, or parent of the benefits and risks of the vaccine.

Injectable Administration

The inactivated polio vaccine (IPV) is administered intramuscularly or subcutaneously; do not give intravenously.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be clear and colorless. If particulate matter or discoloration exist, do not administer the vaccine.
If separate administration sites and syringes are used, IPOL may be given at the same time as diphtheria, tetanus, whole-cell or acellular pertussis, Haemophilus influenzae type b (Hib), and hepatitis B vaccines. No interferences on achievement of immunity have been observed. Injection sites need to be at least 1 inch apart so that any local reaction can be attributed to the appropriate vaccine. If the third dose of IPV is given to a child between 12 and 18 months old, concurrent administration of the Measles/Mumps/Rubella vaccines, MMR and or other vaccines may be desirable. While data regarding any immunological interference are not available regarding the simultaneous use of the IPV with other vaccines including the MMR, pneumococcal vaccine, polyvalent, varicella virus vaccine live, and the influenza virus vaccine, the American College of Immunization Practices (ACIP) has generally encouraged simultaneous administration for the recommended age groups if no contraindications exist. The current information in the guidelines is that inactivated vaccines do not interfere with the immune response to other inactivated vaccines or to live vaccines. Consult recent ACIP guidelines for the most current recommendations on immunization schedules and contraindications. Please note that the ACIP recommendations are not updated annually but rather as new data dictate.
 
Preparation:
Do not mix the IPV with any other vaccine in the same syringe.
A separate, single-use prefilled syringe and needle or a sterile disposable unit must be used for each person receiving IPV. Do not recap needles. Dispose of used materials in an appropriate biohazard container.

Intramuscular Administration

Before administration, clean the skin over the injection site with a suitable cleansing agent.
The preferred IM injection sites are the midlateral aspect of the thigh (particularly for infants) and the deltoid muscle of the upper arm (usually suitable for older children or adults). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
Use different syringes and different injection sites when concomitant administration of other vaccines or immunoglobulin is required.

Subcutaneous Administration

Prior to administration, clean the skin over the injection site with a suitable cleansing agent.
The preferred SC injection sites are the anterolateral aspect of the thigh (particularly for infants) and the deltoid area of the upper arm (usually suitable for older children).
Use different syringes and different injection sites when concomitant administration of other vaccines or immunoglobulin is required.

Adverse Reactions
Severe

anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
seizures / Delayed / Incidence not known

Moderate

erythema / Early / 0-1.4
wheezing / Rapid / Incidence not known

Mild

irritability / Delayed / 6.7-64.5
drowsiness / Early / 4.0-60.7
malaise / Early / 4.0-60.7
lethargy / Early / 4.0-60.7
injection site reaction / Rapid / 0-29.4
anorexia / Delayed / 1.3-16.6
fever / Early / 0-4.2
vomiting / Early / 0-2.8
inconsolable crying / Delayed / 0-1.4
dizziness / Early / Incidence not known
urticaria / Rapid / Incidence not known
headache / Early / Incidence not known
syncope / Early / Incidence not known
paresthesias / Delayed / Incidence not known

Common Brand Names

IPOL

Dea Class

Rx

Description

Inactive vaccine that promotes active immunity to wild-type polioviruses; all-IPV primary immunization regimen recommended in US since 2000 for immunocompetent and immunodeficient infants, children and applicable adults; vaccination may be needed for people with a past clinical infection; complete vaccination can be achieved with OPV, IPV, or a combination of both.

Dosage And Indications
For poliovirus prophylaxis. For poliovirus prophylaxis in incompletely vaccinated adults who travel to areas of the world where polio is common, laboratory workers who might handle polio virus, household members or close contacts of children who receive OPV, and health care workers who treat patients who could have polio. Subcutaneous or Intramuscular dosage Adults

0.5 mL IM or subcutaneously every 4 to 8 weeks to complete a series total of 3 doses.

For poliovirus prophylaxis in vaccinated adults who received 3 doses of either OPV or IPV in the past and who travel to areas of the world where polio is common, laboratory workers who might handle polio virus, household members or close contacts of children who receive OPV, and health care workers who treat patients who could have polio. Subcutaneous or Intramuscular dosage Adults

0.5 mL IM or subcutaneously as a single 'booster' dose. Available data do not indicate the need for more than a single lifetime booster dose with IPV.[48565]

Subcutaneous or Intramuscular dosage Adults who travel to areas of the world where polio is common, laboratory workers who might handle polio virus, household members or close contacts of children who receive oral polio vaccine (OPV), and health care workers who treat patients who could have polio

Only specific adults at risk are recommended for vaccination. 0.5 mL IM or subcutaneously at 4 to 8 week intervals for 2 doses, followed by a third dose of 0.5 mL IM or subcutaneously at 6 to 12 months after the second dose. When an accelerated schedule is needed, all 3 doses may be given over 12 weeks (each dose separated by at least 4 weeks). When less than 4 weeks remains before protection against poliovirus is needed, give a single dose of 0.5 mL IM or subcutaneously.

Infants at least 6 weeks of age, Children, and Adolescents

0.5 mL IM or subcutaneously given at 2, 4, and 6 to 18 months of age (ideally at intervals of at least 8 weeks apart; the minimum interval between doses is 4 weeks). Administer a final booster dose of 0.5 mL IM or subcutaneously after the fourth birthday and at least 6 months after the previous dose; ideally, administration should occur between 4 to 6 years of age. Children younger than 4 years of age who have already received 4 doses of IPV should receive an additional booster dose at 4 to 6 years of age. In a series containing oral polio vaccine (OPV), the total number of doses needed to complete the series is the same as that recommended for the US IPV schedule. Only trivalent OPV (tOPV) counts toward the US vaccination requirements; only doses of OPV administered before April 1, 2016 (and were not part of a campaign) should be counted. During the first 6 months of life, ONLY use the minimum age and minimum intervals for administration if the patient is at risk for imminent exposure to circulating poliovirus (i.e., travel to a polio-endemic region or during an outbreak); lower seroconversion rates have been associated with this immunization schedule.[48565] [53026] [53464]

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. However, consult current immunization schedules for recommended vaccines for use in young pediatric dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.

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

IPOL Intramuscular Inj Susp: 0.5mL, 40-8-32DAgU
IPOL Subcutaneous Inj Susp: 0.5mL, 40-8-32DAgU

Maximum Dosage
Adults

0.5 mL/dose subcutaneously or IM.

Geriatric

0.5 mL/dose subcutaneously or IM.

Adolescents

0.5 mL/dose subcutaneously or IM.

Children

0.5 mL/dose subcutaneously or IM.

Infants

6 weeks and older: 0.5 mL/dose subcutaneously or IM.
less than 6 weeks: Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Mechanism of Action: Poliovirus vaccine, inactivated, IPV stimulates the immune system to produce antibodies against poliovirus wild-types 1, 2, and 3. Following intramuscular or subcutaneous administration, the antigens (inactivated viruses) get presented to the antigen-presenting cells (e.g., B cells, macrophages). The antigen-presenting cells process and present the antigens and allow B-cells to proliferate, differentiate, and produce anti-poliovirus serum antibodies. The serum anti-poliovirus antibodies are capable of opsonization, neutralization, and complement activation. In natural infection, the polio viruses invade and replicate in mucosal tissues. The virus may invade the blood stream and produce disease at distant systemic sites. Parenteral immunization with non-replicating agents, such as the IPV may fail to induce specific mucosal responses. Vaccination with either IPV or the live attenuated oral poliovirus vaccine (OPV) usually induces secretory antibody (IgA) production in the pharynx and gut, but mucosal immunity induced by IPV is less than mucosal immunity induced by OPV. The development of serum anti-poliovirus antibodies caused by either OPV or IPV are effective in the prevention of systemic disease despite their different routes of administration. The IPV helps reduce pharyngeal acquisition of poliovirus and to a lesser extent, intestinal acquisition. Herd immunity is possible with IPV, including populations vaccinated only with IPV.

Pharmacokinetics

Poliovirus Vaccine, Inactivated, IPV is administered intramuscularly or subcutaneously. The pharmacokinetics of the vaccine are not well defined. Poliovirus antibodies have been found in the serum, the pharynx, and the gut. Poliovirus antibodies are distributed into breast milk. A direct relationship exists between the antigenic content of IPV, the frequency of seroconversion, and resulting antibody titers. Detectable serum neutralizing antibodies to all three types of poliovirus have been reported for at least 10 years in children that received an IPV only immunization schedule.
 
Affected cytochrome P450 (CYP450) enzymes and drug transporters: None

Pregnancy And Lactation
Pregnancy

No adequate and well-controlled studies have been conducted in pregnant women receiving poliovirus vaccine, inactivated, IPV and the risk of vaccination to a human fetus or to a woman's reproductive capacity is unknown. Animal reproductive studies have also not been performed. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated 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. The manufacturer recommends administration of the vaccine only if clearly needed. Anti-idiotypic antibodies to poliovirus present in the mother's serum may cross the placenta and actively induce an immune response by the fetus. Anti-idiotypic antibodies are antibodies that recognize idiotypic determinants on antibodies. Thus, babies born to mothers that have been vaccinated for poliovirus may have anti-poliovirus antibody production without direct antigen (poliovirus) exposure. The secretory antibodies, such as IgG and IgM, against poliovirus found in newborns are not transported from the mother to the fetus. Vaccination of all infants is still imperative, as the efficacy and duration of any maternally-induced immunity are unknown.

There is no information on the excretion of the inactivated poliovirus vaccine (IPV) in human milk. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), breast-feeding does not adversely affect immunization of the vaccine recipient. Breast feeding actively stimulates the infant's immune response. Human milk of women vaccinated for poliovirus contains anti-idiotypic antibodies to poliovirus. Anti-idiotypic antibodies are antibodies that recognize idiotypic determinants on antibodies to poliovirus. Thus, breast-fed babies of mothers that have been vaccinated for poliovirus may have anti-poliovirus antibody production without direct antigen (poliovirus) exposure. Vaccination of these infants is still imperative, as the efficacy and duration of any maternally-induced immunity are unknown. 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.