Quadracel Dtap-Ipv

Drug overview for QUADRACEL DTAP-IPV (diphtheria, pertussis(acell),tetanus,polio vaccine/pf):

Generic name: DIPHTHERIA, PERTUSSIS(ACELL),TETANUS,POLIO VACCINE/PF (dip-THEER-ee-uh/TET-un-us/per-TUSS-iss/POE-lee-oh)
Drug class: Diphtheria Toxoid
Therapeutic class: Biologicals

Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed Poliovirus vaccine inactivated (IPV) is an inactivated virus vaccine. IPV (DTaP; Daptacel(R), Infanrix(R)) and tetanus toxoid, reduced diphtheria contains 3 strains of inactivated poliovirus (types 1, 2, and 3) and is toxoid and acellular pertussis vaccine adsorbed (Tdap; Adacel(R), used to stimulate active immunity to poliovirus. IPV also is commercially available in fixed-combination vaccines containing diphtheria, tetanus, Boostrix(R)) are fixed-combination preparations containing tetanus and diphtheria toxins (toxoids) and acellular pertussis vaccine adsorbed onto pertussis, and poliovirus antigens (DTaP-IPV; Kinrix(R), Quadracel(R)); a an aluminum adjuvant and are used to stimulate active immunity to fixed-combination vaccine containing diphtheria, tetanus, pertussis, diphtheria, tetanus, and pertussis.

Antigen potency varies depending on the hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix(R)); and a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus manufacturer. DTaP also is commercially available in fixed-combination and Haemophilus influenza type b (Hib) antigens (DTaP-IPV/Hib; vaccines containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix(R), Quadracel(R)), a fixed-combination vaccine containing Pentacel(R)). Other poliovirus vaccines (e.g., poliovirus vaccine live oral (OPV); no longer commercially available in the US) may be available in diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix(R)), and a combination vaccine containing other countries.

diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel(R)). Although no longer available in the US, diphtheria and tetanus toxoids and whole-cell pertussis vaccine adsorbed (DTP, also referred to as DTwP) may still be used in other countries.

Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed Poliovirus vaccine inactivated (IPV) is used to prevent poliomyelitis by (DTaP) and tetanus toxoid, reduced diphtheria toxoid and acellular stimulating active immunity to poliovirus types 1, 2, and 3. pertussis vaccine adsorbed (Tdap) are used to stimulate active immunity to diphtheria, tetanus, and pertussis. The appropriate vaccine containing The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts recommend diphtheria, tetanus, and pertussis antigens is selected based on age and that all infants, children, and adolescents 17 years of age or younger whether primary or booster immunization is indicated.

(See Uses: Choice of receive primary immunization against poliomyelitis. Primary immunization Vaccines Containing Diphtheria, Tetanus, and Pertussis Antigens.) against poliomyelitis is not routinely recommended for adults 18 years of age or older, unless they are at increased risk of exposure to poliovirus. DTaP or Tdap may be indicated for postexposure vaccination against diphtheria in addition to anti-infective postexposure prophylaxis in IPV is the only poliovirus vaccine commercially available in the US. unvaccinated or inadequately vaccinated household and other close contacts Although immunization regimens that used poliovirus vaccine live oral (OPV; of an individual with diphtheria. (See Uses: Postexposure Prophylaxis of Diphtheria.) no longer commercially available in the US) or sequential IPV/OPV regimens that used both types of vaccines were previously used for primary DTaP or Tdap may be indicated in conjunction with passive immunization with immunization against poliomyelitis in the US, an all-IPV regimen has been tetanus immune globulin (TIG) for postexposure prophylaxis against tetanus used for routine childhood immunization in the US since January 2000.

in individuals with tetanus-prone wounds who are inadequately immunized against tetanus or whose tetanus immunization history is unknown or uncertain. (See Uses: Postexposure Prophylaxis of Tetanus.) DTaP may be indicated for postexposure prophylaxis against pertussis in infants and children who are unvaccinated or incompletely vaccinated against pertussis. (See Uses: Postexposure Prophylaxis of Pertussis.) DTaP and Tdap are not indicated for treatment of diphtheria, tetanus, or pertussis.

However, because diphtheria and tetanus infections do not necessarily confer immunity, initiation or completion of active immunization against these diseases is indicated at the time of recovery in any previously unvaccinated or incompletely vaccinated individual. In addition, although pertussis is likely to confer short-term immunity, the duration of immunity is uncertain (waning may begin as early as 5-7 years after infection) and initiation or completion of active immunization against pertussis is indicated at the time of recovery.

DRUG IMAGES

QUADRACEL DTAP-IPV VIAL

The following indications for QUADRACEL DTAP-IPV (diphtheria, pertussis(acell),tetanus,polio vaccine/pf) have been approved by the FDA:

Indications:
Diphtheria-pertussis-tetanus combined vaccination
Poliomyelitis vaccination

Professional Synonyms:
Active immunization against human poliovirus
Active immunization for diphtheria, pertussis and tetanus
Active immunization for the prevention of poliomyelitis
Diphtheria, pertussis and tetanus vaccination
Poliomyelitis prevention

The following dosing information is available for QUADRACEL DTAP-IPV (diphtheria, pertussis(acell),tetanus,polio vaccine/pf):

Dosing
Administration
Dosing Information
Generic

The poliovirus vaccine dosing schedule varies according to the individual's age and immunization status.

Medically stable preterm and low-birthweight infants generally should be vaccinated at the usual chronologic age using usual dosage. (See Cautions: Pediatric Precautions.)

Interruption of the recommended immunization schedule, regardless of the length of time between doses, does not interfere with the final immunity achieved and does not necessitate additional doses or starting the series over.

The dosing schedule (i.e., number of doses) and specific preparation for primary and/or booster immunization (i.e., DTaP, Tdap) varies depending on age. The age-appropriate recommendations for the specific preparation used should be followed.

DTaP (Daptacel(R), Infanrix(R)) is used only in infants and children 6 weeks through 6 years of age.

Tdap (Adacel(R)) is labeled by the US Food and Drug Administration (FDA) for booster immunization in adolescents 10 years of age or older and adults 19 through 64 years of age; Tdap (Boostrix(R)) is labeled by FDA for booster immunization in adolescents 10 years of age or older and adults 19 years of age or older. Although safety and efficacy of Tdap for primary immunization or for use in children younger than 10 years of age have not been established, ACIP recommends Tdap (Adacel(R), Boostrix(R)) in catch-up primary immunization+ regimens in children 7 through 10 years of age+. In addition, although only Tdap (Boostrix(R)) is labeled by FDA for use in adults 65 years of age or older, ACIP states that either Tdap (Adacel(R)) or Tdap (Boostrix(R)) can be used when booster immunization is indicated in this age group.

ACIP recommends that the same DTaP preparation used for the initial dose be used to complete the primary and booster immunization series since data is limited regarding safety, efficacy, or immunogenicity of the different DTaP vaccine preparations administered interchangeably in the primary or booster immunization series. However, if the particular DTaP vaccine used previously is not known or not available, any age-appropriate commercially available DTaP vaccine should be used to complete the vaccination series.

The complete primary vaccination series and recommended booster doses must be administered to ensure optimal protection against diphtheria and tetanus. Interruption of the recommended primary immunization schedule, regardless of length of time between doses, does not interfere with the final immunity achieved; it is not necessary to give additional doses or start the vaccine series over.

All individuals who received primary immunization with DTaP, DTP (not commercially available in the US), DT, or Td receive a booster dose of a preparation containing diphtheria and tetanus toxoids at 11 through 18 years of age (preferably at 11 through 12 years of age) and routine booster dose of Td every 10 years to maintain adequate immunity against diphtheria and tetanus.

Because adolescents also may be at risk for pertussis, ACIP, AAP, and other experts recommend that a single dose of Tdap (Adacel(R), Boostrix(R)) be used (instead of Td) for the adolescent booster dose at 11 through 18 years of age (preferably at 11 through 12 years of age), unless Tdap has already been given or the pertussis antigens are contraindicated or should not be used. If Tdap is unavailable or was administered previously, Td should be used for this adolescent booster dose.

Adults who have received primary immunization against diphtheria and tetanus should receive routine booster doses of Td every 10 years. In addition, an emergency booster dose of Td may be indicated in the event of injury and possible exposure to tetanus infection. Because adults may be at risk for pertussis, ACIP and other experts recommend that a single dose of Tdap be used (instead of Td) when a booster dose is needed in adults 19 through 64 years of age who have not previously received Tdap, unless pertussis antigens are contraindicated or should not be used.

If Tdap is not available or was administered previously, Td should be used for booster doses.

A single dose of Tdap should be used (instead of Td) when a booster dose of vaccine containing tetanus and diphtheria toxoids is needed in adults 65 years of age or older who have not previously received Tdap. Although only Tdap (Boostrix(R)) is labeled for use in adults 65 years of age or older, ACIP states that either Tdap (Adacel(R)) or Tdap (Boostrix(R)) can be used when a dose of Tdap is indicated in this age group. If Tdap was administered previously, Td should be used for subsequent booster doses.

(See Uses: Primary and Booster Immunization with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).)

Parents or caregivers of children receiving booster doses of DTaP (fourth or fifth doses) should be informed that increases in reactogenicity have been reported with these doses compared with the first 3 doses of the vaccination series. Parents also should be informed that edematous swelling involving the entire thigh or upper arm has been reported. Whether children who experience entire limb swelling after a fourth dose of DTaP are at increased risk for this reaction after the fifth dose is unknown.

However, because reports to date indicate that the reactions are self-limited and resolve without sequelae and because of the benefits provided by the preschool booster dose of DTaP (fifth dose), ACIP states that a history of extensive swelling after the fourth dose should not be considered a contraindication for receipt of the fifth dose of DTaP. The fact that these reactions may be clinically indistinguishable from other conditions (e.g., cellulitis) that require treatment should be considered. Therefore, ACIP recommends that providers make decisions regarding evaluation and management of children with suspected reactions to DTaP on a case-by-case basis.

Poliovirus vaccine inactivated (IPV; IPOL(R)) is administered by IM or subcutaneous injection. IPV should not be administered IV. Fixed-combination vaccines containing IPV and diphtheria, tetanus, and pertussis antigens (DTaP-IPV; Kinrix(R), Quadracel(R)), the fixed-combination vaccine containing IPV and diphtheria, tetanus, pertussis, and hepatitis B antigens (DTaP-HepB-IPV; Pediarix(R)), and the vaccine containing IPV and diphtheria, tetanus, pertussis, and Haemophilus influenza type b (Hib) antigens (DTaP-IPV/Hib; Pentacel(R)) are administered by IM injection.

These combination vaccines should not be administered subcutaneously, intradermally, or IV. Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements). Syncope occurs most frequently in adolescents and young adults.

Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination. If syncope occurs, the patient should be observed until symptoms resolve.

When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at a different injection site. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur. Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) are administered only by IM injection.

DTaP and Tdap should not be administered subcutaneously, intradermally, or IV. To ensure delivery into muscle, IM injections should be made at a 90degrees angle to the skin using a needle length appropriate for the individual's age and body mass, thickness of adipose tissue and muscle at the injection site, and the injection technique. Depending on patient age, IM injections of DTaP or Tdap should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm.

In adults, adolescents, and children 3 years of age or older, IM injections should preferably be made in the region of the deltoid muscle. In infants and children 6 weeks through 2 years of age, IM injections should preferably be made into the anterolateral thigh; alternatively, the deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate. DTaP and Tdap should not be injected into the gluteal area or any area where there may be a major nerve trunk.

If the gluteal muscle is chosen for infants younger than 12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that the clinician identify anatomic landmarks prior to injection. DTaP and Tdap should be inspected visually for particulate matter and discoloration prior to administration. Prior to use, vials or prefilled syringes of DTaP or Tdap should be shaken vigorously until a uniform, turbid, white suspension results.

DTaP and Tdap should not be used if the vaccines cannot be resuspended. Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements). Syncope occurs most frequently in adolescents and young adults.

Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination. If syncope occurs, the patient should be observed until symptoms resolve.

DTaP or Tdap should not be mixed with any other vaccine or solution. Although DTaP is commercially available in a kit containing DTaP and inactivated poliovirus vaccine (DTaP-IPV) and Haemophilus b (Hib) vaccine to provide a combination vaccine containing DTaP, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel(R)), extemporaneous vaccine combinations of DTaP or Tdap and other commercially available vaccines should not be prepared by admixing the vaccines. When passive immunization with tetanus immune globulin (TIG) is indicated in addition to active immunization with a preparation containing tetanus toxoid adsorbed for postexposure prophylaxis of tetanus, DTaP or Tdap may be given simultaneously with TIG using different syringes and different injection sites.

DTaP or Tdap may be given simultaneously with other age-appropriate vaccines. (See Drug Interactions: Vaccines.) When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given with a different syringe and at different injection sites. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for QUADRACEL DTAP-IPV (diphtheria, pertussis(acell),tetanus,polio vaccine/pf):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)	TZIELD

Drug Interaction

Drug Names

Non-Live or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames.

The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.

Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

TZIELD

There are 8 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Fingolimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)	FINGOLIMOD, GILENYA, TASCENSO ODT
Non-Live or Non-Replicating Vaccines/Siponimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2) CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)	MAYZENT
Non-Live or Non-Replicating Vaccines/Satralizumab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)	ENSPRYNG
Non-Live or Non-Replicating Vaccines/Ublituximab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)	BRIUMVI
Systemic Corticosteroids; Corticotropin/Non-Live or Non-Replicating Vaccines SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1) DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETA 1, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BSP 0820, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, JAYTHARI, KENALOG-10, KENALOG-40, KENALOG-80, KHINDIVI, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, ORTIKOS, PEDIAPRED, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PRO-C-DURE 5, PRO-C-DURE 6, PROCTOCORT, RAYOS, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Non-Live or Non-Replicating Vaccines/Etrasimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.	VELSIPITY
Non-Live or Non-Replicating Vaccines/Ozanimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.	ZEPOSIA
Non-Live or Non-Replicating Vaccines/Ponesimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.	PONVORY

Severe List
Febrile convulsions
Guillain-barre syndrome
High fever >101 degrees fahrenheit
Infantile spasms
Uncontrolled epilepsy

The following adverse reaction information is available for QUADRACEL DTAP-IPV (diphtheria, pertussis(acell),tetanus,polio vaccine/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 20 severe adverse reactions.

More Frequent	Less Frequent
Erythema High fever >101 degrees fahrenheit	None.

Rare/Very Rare
Anaphylaxis Cellulitis Cerebrovascular accident Cyanosis Dehydration Encephalopathy Facial edema Febrile convulsions Gastroenteritis Guillain-barre syndrome Hypernatremia Hypersensitivity drug reaction Pruritus of skin Shock Syncope Thrombocytopenic disorder Tonic clonic seizure Urticaria

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Drowsy Extensive limb swelling after injection Fever Injection site sequelae Irritability Lethargy Skin swelling	None.

Rare/Very Rare
Constipation Headache disorder Hypotonia Injection site abscess Injection site inflammation Lymphadenopathy Malaise Myalgia Pallor Paresthesia Visual changes

The following precautions are available for QUADRACEL DTAP-IPV (diphtheria, pertussis(acell),tetanus,polio vaccine/pf):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Animal reproduction studies have not been performed to date with IPV. It is not known if the vaccine can cause fetal harm when administered to pregnant women. IPV should be administered during pregnancy only when clearly needed.

Pregnant women generally do not need to be immunized against poliomyelitis unless they are at substantial risk of imminent exposure to infection (e.g., traveling to areas of high risk). If a pregnant woman is unvaccinated or incompletely vaccinated and requires immediate protection against poliovirus because of planned travel to a country or area where wild-type poliovirus is actively circulating, CDC states that IPV can be administered as recommended for other adults. (See Travelers under Uses: Primary Immunization.) DTaP-IPV (Kinrix(R), Quadracel(R)), DTaP-HepB-IPV (Pediarix(R)), and DTaP-IPV/Hib (Pentacel(R)) are not indicated for use in adults, including pregnant women.

Animal reproduction studies have not been performed with Tdap (Adacel(R)). A developmental toxicity study in female rats using Tdap (Boostrix(R)) at a dose approximately 40 times the human dose (on a mL/kg basis) did not reveal evidence of harm to the fetus. Animal fertility studies have not been conducted with Tdap (Adacel(R), Boostrix(R)).

There are no adequate and well-controlled studies using Tdap in pregnant women, and it is not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The manufacturers state that Tdap should be used during pregnancy only when clearly needed. ACIP and AAP state that pregnancy is not generally considered a contraindication to Tdap if a dose is indicated to provide protection against pertussis.

ACIP states that available data do not suggest any elevated frequency or unusual patterns of adverse events in pregnant women who received Tdap and the few serious adverse events reported were unlikely to have been caused by the vaccine. These experts state that the potential benefit of preventing pertussis morbidity and mortality in infants outweighs theoretical concerns of possible severe adverse events. Ideally, primary immunization against tetanus and diphtheria should be completed prior to pregnancy.

Pregnant women who have not received primary immunization with DTaP, DTP (not commercially available in the US), DT, Td, or single-antigen tetanus toxoid adsorbed and those with unknown or incomplete tetanus immunization should receive a primary series of 3 doses of vaccine containing diphtheria and tetanus toxoids beginning during pregnancy. Although Td usually is the preferred preparation for primary or booster immunization against diphtheria and tetanus in adults, ACIP, AAP, and other experts state that all pregnant women should receive a dose of Tdap, regardless of prior vaccination. When primary or booster immunization against diphtheria and tetanus is indicated during pregnancy in previously unvaccinated or incompletely vaccinated pregnant women, ACIP and other experts state that a dose of Tdap should be substituted for one of the required Td doses, preferably during the third trimester (optimally between 27 and 36 weeks of gestation).

In addition, to ensure protection against pertussis, these experts recommend that a dose of Tdap be administered during each pregnancy, regardless of the woman's prior vaccination history. To maximize the maternal antibody response and passive antibody transfer to the infant, the optimal timing for the Tdap dose is between 27 and 36 weeks of gestation. Pregnant women who were previously vaccinated but received the most recent dose of a preparation containing tetanus and diphtheria toxoids 10 or more years previously should receive a booster dose of a preparation containing tetanus toxoid during the second or third trimester of pregnancy (and before 36 weeks of gestation).

This dose is important if the woman does not have sufficient tetanus immunity to protect against maternal and neonatal tetanus or if protection against diphtheria is needed (e.g., for travel to an area where diphtheria is endemic). ACIP and other experts state that Tdap should be used for the booster dose (instead of Td). If postexposure prophylaxis of tetanus is indicated as part of wound management in a pregnant woman, the usual recommendations regarding emergency booster doses should be followed.

(See Uses: Postexposure Prophylaxis of Tetanus.) Tdap should be used for the booster dose (instead of Td). Clinicians are encouraged to register pregnant women who receive Tdap with the manufacturer's pregnancy registry at 800-822-2463 (Adacel(R)) or 888-452-9622 (Boostrix(R)).

It is not known whether antigens contained in IPV are distributed into milk. The manufacturer states that IPV should be used with caution in nursing women. Although specific data are not available, ACIP and AAP state that breast-feeding is not a contraindication to administration of inactivated vaccines since inactivated vaccines do not multiply within the body and such vaccines appear to pose no special problems for the mother or her nursing infant.

CDC states that breast-feeding is not a contraindication for use of IPV in the infant or mother. It is not known whether Tdap (Adacel(R), Boostrix(R)) is distributed into milk. The manufacturers state that Tdap should be used with caution in nursing women. ACIP states that breast-feeding is not a contraindication for Tdap and women, including those who are breastfeeding, should receive a single dose of Tdap during the immediate postpartum period if they have not previously received a dose.

No enhanced Geriatric Use information available for this drug.

Diphtheria-pertussis-tetanus combined vaccination
Z23	Encounter for immunization
Poliomyelitis vaccination
Z23	Encounter for immunization