Menveo A-C-Y-W-135-Dip

Drug overview for MENVEO A-C-Y-W-135-DIP (meningococcalvaccine a,c,y,w-135,diphtheria toxoid conj/pf):

Generic name: MENINGOCOCCALVACCINE A,C,Y,W-135,DIPHTHERIA TOXOID CONJ/PF (MEN-in-go-COC-al)
Drug class: Meningococcal Vaccines - Serogroups A,C,Y,W135
Therapeutic class: Biologicals

Meningococcal groups A, C, Y, and W-135 vaccine (MenACWY) is an inactivated (polysaccharide) vaccine that is commercially available in the US as 3 different quadrivalent conjugated vaccines: meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra(R)), meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM; Menveo(R)), and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi(R)). These conjugated vaccines contain A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis linked to a carrier protein and are used to stimulate active immunity to meningococcal infection caused by serogroups A, C, Y, and W-135.

Meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra(R)), meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM; Menveo(R)), and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi(R)) are quadrivalent conjugated meningococcal groups A, C, Y, and W-135 (MenACWY) vaccines used to stimulate active immunity to infection caused by Neisseria meningitidis serogroups represented in the vaccines. MenACWY vaccines are used for primary and booster immunization against infection caused by N. meningitidis serogroups A, C, Y, and W-135.

MenACWY vaccines also may be used as an adjunct to anti-infective prophylaxis in household and other contacts of individuals with invasive meningococcal disease when cluster cases or outbreaks are caused by N. meningitidis serogroups represented in the vaccines. MenACWY vaccines will not stimulate immunity to meningococcal infection caused by N.

meningitidis serogroups not represented in the vaccines (e.g., serogroup B) or to infections caused by other pathogens. The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts recommend routine primary immunization against meningococcal serogroups A, C, Y, and W-135 infection in all adolescents using MenACWY vaccine, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age. These experts recommend catch-up vaccination with MenACWY vaccine at 13 through 18 years of age for those not previously vaccinated against meningococcal serogroups A, C, Y, and W-135 infection.

Catch-up vaccination with MenACWY vaccine also is recommended for all first-year college students living in residence halls if they did not receive a dose of the vaccine on or after their 16th birthday. ACIP, AAP, and other experts also recommend routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine in selected adults, adolescents, children, and infants 2 months of age or older at increased risk for the disease because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, human immunodeficiency virus (HIV) infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease caused by serogroups represented in the vaccine. Primary and booster immunization with MenACWY vaccine also is recommended for some other individuals at increased risk for meningococcal disease (e.g., certain health-care and laboratory personnel, military recruits).

DRUG IMAGES

MENVEO A-C-Y-W KIT (2 VIALS)

The following indications for MENVEO A-C-Y-W-135-DIP (meningococcalvaccine a,c,y,w-135,diphtheria toxoid conj/pf) have been approved by the FDA:

Indications:
Meningococcal vaccination

Professional Synonyms:
Active immunization against Neisseria meningitidis
Active immunization for the prevention of meningococcal disease

The following dosing information is available for MENVEO A-C-Y-W-135-DIP (meningococcalvaccine a,c,y,w-135,diphtheria toxoid conj/pf):

Dosing
Administration
MENVEO A-C-Y-W-135-DIP
Generic

The dosage schedule (i.e., number and timing of doses for primary immunization) and specific MenACWY vaccine administered (MenACWY-D, MenACWY-CRM, MenACWY-TT) depend on the individual's age, immunization status, and risk factors. The age-appropriate recommendations for the specific preparation used should be followed.

ACIP states that MenACWY-D, MenACWY-CRM, and MenACWY-TT can be used interchangeably, including use in an age-appropriate multiple-dose primary immunization series or for booster doses after primary immunization. ACIP states that if the same MenACWY vaccine used previously is not available or not known, any age-appropriate MenACWY vaccine can be administered for subsequent doses.

If interruptions or delays result in an interval between vaccine doses longer than recommended, ACIP states that it is not necessary to administer additional doses or start the vaccination series over.

In an open-label trial conducted in the US, 834 individuals who had previously received a dose of MenACWY-D received a booster dose of the vaccine 4-6 years after the prior dose (median age at the time of the booster dose was 17.1 years). Prior to the booster dose, approximately 65, 44, 39, and 69% of 781 trial participants had hSBA titers of at least 1:8 for meningococcal serogroups A, C, Y, and W-135, respectively. At day 28 after the booster dose, more than 99% of trial participants had hSBA titers of at least 1:8 for each of the meningococcal serogroups.

In a subset of 112 trial participants for whom hSBA responses were assessed at day 6 after the booster dose, approximately 87, 91, 95, and 92% achieved at least a fourfold increase in hSBA titer for meningococcal serogroups A, C, Y, and W-135, respectively. Data for all 781 trial participants indicated that by day 28 after the booster dose, 95, 95, 97, and 96% had achieved at least a fourfold increase in hSBA titer for meningococcal serogroups A, C, Y, and W-135, respectively.

In an open-label multicenter trial conducted in the US, 601 individuals who had previously received a dose of MenACWY-CRM or MenACWY-D received a booster dose of MenACWY-CRM given 4-6 years after the prior dose (median age at the time of the booster dose was 16 years). In 290 trial participants who previously received MenACWY-CRM, 12, 62, 54, and 76% had hSBA titers of at least 1:8 for meningococcal serogroups A, C, Y, and W-135, respectively, prior to the booster dose; at day 29 after the booster dose, the seroresponse rates in these individuals were 97, 95, 97, and 96% for meningococcal serogroups A, C, Y, and W-135, respectively. In individuals who had previously received a dose of MenACWY-D, seroresponse rates after the booster dose of MenACWY-CRM were similar to those in the group who had previously received MenACWY-CRM.

In a double-blind, randomized, parallel-group trial, 402 adolescents and adults 15 years of age or older who had previously received a dose of MenACWY-D or unconjugated MPSV4 (no longer available in the US) received a booster dose of MenACWY-TT given 4-10 years after the prior dose (median age at the time of the booster dose was 18 years). Seroresponse rates at 1 month after the booster dose were 92, 97, 97, and 98% for meningococcal serogroups A, C, Y, and W-135, respectively.

No enhanced Administration information available for this drug.

Dosing information for MENVEO A-C-Y-W-135-DIP
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
MENVEO 1 VIAL-A-C-Y-W-135-DIP	Maintenance	Adults inject 0.5 milliliter by intramuscular route once

No generic dosing information available.

The following drug interaction information is available for MENVEO A-C-Y-W-135-DIP (meningococcalvaccine a,c,y,w-135,diphtheria toxoid conj/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

Moderate List
Guillain-barre syndrome
Severe infection

The following adverse reaction information is available for MENVEO A-C-Y-W-135-DIP (meningococcalvaccine a,c,y,w-135,diphtheria toxoid conj/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Accidental fall Anaphylaxis Bell's palsy Exfoliative dermatitis Guillain-barre syndrome Syncope

There are 29 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Arthralgia Diarrhea Drowsy Erythema Fatigue Headache disorder Induration of skin Injection site sequelae Irritability Malaise Myalgia Nausea	Chills Fever Skin rash Vomiting

Rare/Very Rare
Blepharoptosis Bone pain Cellulitis Dizziness Earache Extensive limb swelling after injection Facial palsy Hearing loss Pain in oropharynx Pruritus of skin Seizure disorder Vertigo

The following precautions are available for MENVEO A-C-Y-W-135-DIP (meningococcalvaccine a,c,y,w-135,diphtheria toxoid conj/pf):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There are no adequate and well-controlled studies evaluating MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) in pregnant women. MenACWY-D: Available data suggest that rates of major birth defects and miscarriage in women who received the vaccine 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates. Animal reproduction studies performed in pregnant mice using 0.1

mL of the vaccine administered 14 days prior to mating and on days 6 and 18 of gestation did not reveal any vaccine-related fetal malformations or variations and no adverse effects on postnatal development. Clinicians are encouraged to report any exposure to MenACWY-D that occurs during pregnancy to the manufacturer's vaccination pregnancy registry at 800-822-2463. MenACWY-CRM: Animal reproduction studies performed in female rabbits using a dosage of the vaccine approximately 20 times the human dose (calculated on a mg/kg basis) did not reveal evidence of harm to the fetus.

Data for 82 women enrolled in a pregnancy registry from 2014-2017 do not suggest an increased risk of major birth defects or miscarriage in women who received the vaccine within 28 days prior to conception or during pregnancy. MenACWY-TT: Animal reproduction studies performed in female rabbits using 0.5 mL of the vaccine administered 30 and 10 days prior to mating and on days 6, 12, and 27 of gestation did not reveal evidence of harm to the fetus or adverse effects on postnatal development.

Clinicians are encouraged to report any exposure to MenACWY-TT that occurs during pregnancy to the manufacturer's pregnancy registry at 800-822-2463. ACIP and AAP state that MenACWY vaccine may be used during pregnancy if indicated. ACIP states that, although data are limited, postmarketing surveillance has not identified any concerning safety signals regarding use of MenACWY vaccines during pregnancy.

Analysis of anticapsular antibody levels in maternal and cord blood samples obtained at the time of delivery from women who received unconjugated capsular polysaccharide antigens from N. meningitidis serogroups A and C (not commercially available in the US) indicate that pregnant women have a good antibody response to antigens from both serogroup A and C, and these antibodies cross the placenta. The extent of placental transfer of group A and C antibodies shows considerable interindividual variation; the ratio of cord blood anticapsular antibody levels to maternal anticapsular antibody levels has ranged from 0.1-1.1

(mean: 0.3-0.6). Levels of maternal group A and C antibodies in the child decline over the first few months after birth; by 4-8 months of age, children born to mothers who were vaccinated during pregnancy have anticapsular antibody levels similar to those in children born to unvaccinated mothers. There was no evidence that administration of bivalent meningococcal vaccines containing capsular polysaccharide antigens from serogroups A and C to pregnant women had any effect on the antibody response in the child following subsequent vaccination with a meningococcal polysaccharide vaccine.

It is not known whether antigens contained in MenACWY vaccine are distributed into milk. The manufacturers state that the benefits of breast-feeding and the importance of MenACWY vaccine to the woman should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to meningococcal infection). ACIP states that breast-feeding women should receive MenACWY vaccine if indicated.

No enhanced Geriatric Use information available for this drug.

Meningococcal vaccination
Z20.811	Contact with and (suspected) exposure to meningococcus
Z23	Encounter for immunization