Decavac (Pf)

Drug overview for DECAVAC (PF) (tetanus and diphtheria toxoids, adsorbed, adult/pf):

Generic name: TETANUS AND DIPHTHERIA TOXOIDS, ADSORBED, ADULT/PF (dip-THEER-ee-uh AND TET-un-us)
Drug class: Diphtheria Toxoid
Therapeutic class: Biologicals

Diphtheria and tetanus toxoids adsorbed (DT) and tetanus and diphtheria toxoids adsorbed (Td) are fixed-combination preparations contain tetanus and diphtheria toxins (toxoids) adsorbed onto an aluminum adjuvant and are used to stimulate active immunity to diphtheria and tetanus. DT contains a higher dose of diphtheria toxoid than Td.

Diphtheria and tetanus toxoids adsorbed (DT) is used to stimulate active immunity to diphtheria and tetanus in infants and children 6 weeks through 6 years of age; tetanus and diphtheria toxoids adsorbed (Td) is used to stimulate active immunity to diphtheria and tetanus in adults, adolescents, and children 7 years of age or older. The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), and other experts recommend that all individuals receive routine immunization against diphtheria, tetanus, and pertussis. Use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines; considerations should include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage requirements, cost), patient preference, and potential for adverse effects.

Therefore, a fixed-combination preparation that contains antigens for all 3 diseases (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed; DTaP) is preferred for primary and booster immunization against these diseases in infants and children 6 weeks through 6 years of age unless pertussis antigens are contraindicated or should not be used. DT should be used for primary or booster immunization against diphtheria and tetanus only when DTaP cannot be used. (See Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08.) Td usually is the preparation of choice for primary and booster immunization against diphtheria and tetanus in adults, adolescents, and children 7 years of age or older.

However, to reduce the morbidity associated with pertussis, ACIP, AAP, and other experts recommend that a single dose of a fixed-combination preparation that also contains pertussis antigens (tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap)) be used in place of a required primary or booster dose of Td in individuals 7 years of age or older who have not previously received Tdap, unless pertussis antigens are contraindicated or should not be used. Individuals in this age group who previously received a dose of Tdap should then receive Td for subsequent primary or booster doses. (See Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08.) DT or Td may be indicated for postexposure vaccination against diphtheria in addition to anti-infective postexposure prophylaxis in unvaccinated or inadequately vaccinated household and other close contacts of an individual with diphtheria.

(See Uses: Postexposure Prophylaxis of Diphtheria.) DT or Td may be indicated in conjunction with passive immunization with tetanus immune globulin (TIG) for postexposure prophylaxis against tetanus 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.) DT and Td are not indicated for treatment of diphtheria or treatment of tetanus infection. 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.

DRUG IMAGES

TENIVAC VIAL

The following indications for DECAVAC (PF) (tetanus and diphtheria toxoids, adsorbed, adult/pf) have been approved by the FDA:

Indications:
Tetanus-diphtheria prevention

Professional Synonyms:
Tetanus and diphtheria prevention
Tetanus and diphtheria prophylaxis

The following dosing information is available for DECAVAC (PF) (tetanus and diphtheria toxoids, adsorbed, adult/pf):

Dosing
Administration
TENIVAC
Generic

DT and Td are administered in 0.5-mL doses.

Each 0.5 mL of DT contains 25 flocculation units (Lf) units of diphtheria toxoid adsorbed and 5 Lf units of tetanus toxoid adsorbed.

Each 0.5 mL of Td contains 2 Lf units of diphtheria toxoid adsorbed and, depending on the manufacturer, either 2 or 5 Lf units of tetanus toxoid adsorbed.

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

DT is used only in infants and children 6 weeks through 6 years of age and only when diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) cannot be used (i.e., when pertussis antigens are contraindicated or should not be used).

Td is used only in adults, adolescents, and children 7 years of age or older.

The complete primary vaccination series and recommended booster doses must be administered to ensure optimal protection against diphtheria and tetanus. Interruption of the primary immunization series resulting in intervals between doses longer than recommended do not interfere with the final immunity achieved; therefore, it is not necessary to give additional doses or to start the series over.

If an accelerated immunization schedule is necessary in infants and children 6 weeks through 6 years of age (e.g., for catch-up immunization, immunization prior to travel), the minimum intervals between the first, second, and third doses of DT are 4 weeks and the minimum intervals between the third, fourth, and fifth doses are 6 months. In adults, adolescents, and children 7 years of age or older, the minimum interval between the first and second dose of Td is 4 weeks and the minimum interval between second and third dose is 6 months.

All individuals who received primary immunization with DTaP, diphtheria and tetanus toxoids adsorbed and whole-cell pertussis vaccine (DTP; not commercially available in the US), DT, or Td should receive a booster dose of a preparation containing diphtheria and tetanus toxoids adsorbed at 11 through 18 years of age (preferably at 11 through 12 years of age) and routine booster doses 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 be used (instead of Td) for the adolescent booster dose given at 11 through 18 years of age (preferably at 11 through 12 years of age), unless Tdap has already been given or pertussis antigens are contraindicated or should not be used. If Tdap is unavailable or was administered previously, a dose of Td should be used for this adolescent booster dose. (See Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08.)

All adults who 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. (See Uses: Postexposure Prophylaxis of Tetanus.)

ACIP and other experts recommend that a single dose of Tdap should be used (instead of Td) when a booster dose is needed in adults 19 years of age or older (including those 65 years of age or older), unless pertussis antigens are contraindicated or should not be used. Thereafter, Td should be used whenever a booster dose is indicated.

Booster doses of Td should only be administered when indicated. Booster doses given more frequently than recommended are associated with an increased incidence and severity of adverse effects.

Routine booster doses of Td should be administered once every 10 years. Emergency booster doses are not usually indicated unless at least 5 years have elapsed since the last dose. If a booster dose is given earlier than 10 years after a previous dose, the next routine booster dose should not be given for 10 years.

Diphtheria and tetanus toxoids adsorbed (DT) and tetanus and diphtheria toxoids adsorbed (Td) are administered only by IM injection. 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 DT or Td 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 deltoid muscle. In infants and children 6 weeks to 2 years of age, IM injections should preferably be made into the anterolateral thigh; alternatively, the deltoid muscle can be used in those 1-2 years of age if muscle mass is adequate. The gluteal area or areas where there may be a major nerve trunk should be avoided.

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. DT and Td should be inspected visually for particulate matter and discoloration prior to administration. To ensure a uniform suspension of antigens, single-dose vials of DT or single-dose vials or single-dose prefilled syringes of Td should be shaken well prior to use.

After shaking, a uniform, white, cloudy suspension should result; the vaccine should be discarded if it contains particulate matter, is discolored, or 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.

DT and Td should not be diluted and should not be mixed with any other vaccine or solution. 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, DT or Td may be given simultaneously with TIG using different syringes and different injection sites. (See Uses: Postexposure Prophylaxis of Tetanus.) DT or Td may be given simultaneously with other age-appropriate 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.

Dosing information for TENIVAC
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
TENIVAC VIAL	Maintenance	Adults inject 0.5 milliliter by intramuscular route once

No generic dosing information available.

The following drug interaction information is available for DECAVAC (PF) (tetanus and diphtheria toxoids, adsorbed, adult/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, KENALOG-10, KENALOG-40, KENALOG-80, 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
High fever >101 degrees fahrenheit

The following adverse reaction information is available for DECAVAC (PF) (tetanus and diphtheria toxoids, adsorbed, adult/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
Headache disorder	None.

Rare/Very Rare
Anaphylaxis Angioedema Brachial plexus disorder Dyspnea Encephalopathy Erythema multiforme Guillain-barre syndrome Hearing disorder Hypersensitivity drug reaction Localized edema Urticaria

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Arthralgia Injection site sequelae Malaise Muscle weakness	None.

Rare/Very Rare
Chills Dizziness Fatigue Fever Flushing Hypotension Lymphadenopathy Myalgia Nausea Paresthesia Peripheral edema Skin rash Syncope Tachycardia Vomiting

The following precautions are available for DECAVAC (PF) (tetanus and diphtheria toxoids, adsorbed, adult/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 with Td. It is not known whether the toxoids can cause fetal harm, and they should be used during pregnancy only when clearly needed. Tetanus toxoids have been administered to pregnant women to prevent tetanus in neonates considered to be at high risk for the disease.

Because of the risks associated with tetanus and diphtheria infection, ACIP, American Academy of Pediatrics (AAP), and other experts state that preparations containing diphtheria and tetanus antigens are not contraindicated during pregnancy. Although there is no evidence that diphtheria and tetanus toxoids are teratogenic, waiting until the second or third trimester of pregnancy (and before 36 weeks of gestation) to administer Td is recommended. 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 (not commercially available in the US) and those whose tetanus immunization history is unknown or uncertain should receive a primary series of 3 doses of vaccine containing diphtheria and tetanus toxoids beginning during pregnancy. Although Td generally is the preferred preparation for primary immunization against diphtheria and tetanus during pregnancy, ACIP, AAP, and other experts state that a dose of Tdap should be substituted for one of the required primary Td doses, preferably in the third trimester (optimally between 27 and 36 weeks of gestation) in previously unvaccinated or incompletely vaccinated pregnant women. 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 maternal antibody response and passive antibody transfer to the infant, optimal timing for the Tdap dose is between 27 and 36 weeks of gestation. (See Pregnant Women under Uses: Primary and Booster Immunization with Tetanus and Diphtheria Toxoids Adsorbed (Td).) When a pregnant woman's history of tetanus vaccination is uncertain, serologic testing can be done to determine whether she has protective levels of tetanus antitoxin (i.e., at least 0.1 international units when tested using enzyme-linked immunosorbent assay (ELISA)).

Those who have never been vaccinated against tetanus or have levels of tetanus antitoxin that are not protective should be vaccinated during pregnancy to ensure protection against maternal and neonatal tetanus. Because diphtheria is rare in the US, serologic testing for diphtheria antitoxin is not usually necessary in pregnant women. Two doses of a preparation containing tetanus toxoid adsorbed given at least 4-6 weeks before delivery stimulates tetanus antitoxin levels that protect the mother and readily cross the placenta to protect the neonate against tetanus.

(See Pregnant Women under Uses: Primary and Booster Immunization with Tetanus and Diphtheria Toxoids Adsorbed (Td).) Sufficient tetanus protection is likely if the pregnant woman is younger than 31 years of age and received the complete childhood tetanus and diphtheria vaccination series and a booster dose of Td during adolescence or received the complete adult vaccination series of 3 doses of Td or single-antigen tetanus toxoid adsorbed (not commercially available in the US). Sufficient tetanus protection may also be present if the pregnant woman is 31 years of age or older and received the complete childhood vaccination series and at least 2 booster doses of Td; if the pregnant woman received a primary vaccination series consisting of 3 doses of Td or single-antigen tetanus toxoid adsorbed during adolescence or as an adult; or if serologic testing indicates protective levels of serum tetanus antitoxin.

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).

It is not known whether diphtheria or tetanus toxoids are distributed into milk. The manufacturers state that Td for adult use should be used with caution in nursing women. ACIP states that breastfeeding is not considered a contraindication for diphtheria and tetanus toxoids adsorbed.

No enhanced Geriatric Use information available for this drug.