Menveo Mencyw-135 Component

Drug overview for MENVEO MENCYW-135 COMPONENT (meningococcal c,y,w-135,dip-conj vaccine component 2 of 2/pf):

Generic name: MENINGOCOCCAL C,Y,W-135,DIP-CONJ VACCINE COMPONENT 2 OF 2/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 contains antigens extracted from Neisseria meningitidis linked to a carrier protein; it is used to stimulate active immunity to meningococcal infection caused by serogroups A, C, Y, and W-135.

No enhanced Uses information available for this drug.

DRUG IMAGES

MENVEO MENCYW-135 COMPONENT

The following indications for MENVEO MENCYW-135 COMPONENT (meningococcal c,y,w-135,dip-conj vaccine component 2 of 2/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 MENCYW-135 COMPONENT (meningococcal c,y,w-135,dip-conj vaccine component 2 of 2/pf):

Dosing
Administration
Dosing Information
Generic

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

Consult the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) vaccination schedules for specific dosage information, including detailed recommendations for certain scenarios (e.g., catch-up vaccination) and high-risk conditions.

The CDC and ACIP state that MenACWY-CRM and MenACWY-TT can be used interchangeably; however, the same vaccine is recommended (but not required) for all doses.

MenACWY-TT and MenACWY-CRM are administered IM in 0.5-mL doses.

There are 2 different vaccines commercially available in the US for active immunization for prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135: 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 vaccines are administered only by IM injection. MenACWY vaccines usually can be given concurrently with other age-appropriate vaccines.

When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separates syringes and different injection sites. Injection sites should be separated by >=1 inch if possible. Depending on patient age, IM injections should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm.

In infants younger than 12 months of age, IM injections should preferably be made into the anterolateral thigh. In certain circumstances (e.g., physical obstruction at other sites and no reasonable indication to defer the vaccine dose), IM injections can be made into the gluteal muscle using care to identify anatomical landmarks prior to injection. In infants and children 1 through 2 years of age, the anterolateral thigh is the preferred site for IM injections; alternatively, IM injections can be made into the deltoid muscle if muscle mass is adequate.

In adults, adolescents, and children 3 years of age or older, IM injections should preferably be made into the deltoid muscle; alternatively, IM injections can be made into the anterolateral thigh. 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 injection technique. Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.

All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained. Meningococcal vaccine that has been mishandled or has not been stored at the recommended temperature should not be administered. If there are concerns about mishandling, the manufacturer or state or local immunization or health departments should be contacted for guidance on whether the vaccine is usable.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for MENVEO MENCYW-135 COMPONENT (meningococcal c,y,w-135,dip-conj vaccine component 2 of 2/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, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, 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, KYMBEE, 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, P-PACK PREDNISONE, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PROCTOCORT, PYQUVI, 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 MENCYW-135 COMPONENT (meningococcal c,y,w-135,dip-conj vaccine component 2 of 2/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

MenACWY-CRM: Adverse effects reported most frequently in infants initiating vaccination at 2 months of age and receiving a 4-dose series of MenACWY-CRM were tenderness (24-41%) and erythema (11-15%) at the injection site, irritability (42-57%), sleepiness (29-50%), persistent crying (21-41%), change in eating habits (17-23%), vomiting (5-11%), and diarrhea (8-16%). Adverse effects reported most frequently in children initiating vaccination at 7 months through 23 months of age and receiving a 2-dose series of MenACWY-CRM were tenderness (10-16%) and erythema at injection site (12-15%), irritability (27-40%), sleepiness (17-29%), persistent crying (12-21%), change in eating habits (12-20%), and diarrhea (10-16%). Adverse effects reported most frequently when MenACWY-CRM was used in children 2 through 10 years of age were injection site pain (31%), erythema (23%), irritability (18%), induration (16%), sleepiness (14%), malaise (12%), and headache (11%).

Among adolescents and adults 11 through 55 years of age, the most frequently reported adverse effects were injection site pain (41%), headache (30%), myalgia (18%), malaise (16%), and nausea (10%). Similar rates of solicited adverse effects were observed following a single booster dose. MenACWY-TT: In infants who received a 4-dose series of MenACWY-TT administered at 2, 4, 6, and 12-18 months of age, the most common adverse effects were tenderness (39-46%), erythema (13-20%), and swelling (10-13%) at the injection site; irritability (40-52%); abnormal crying (27-42%); drowsiness (25-43%); loss of appetite (17-22%); fever (8-18%); and vomiting (4-13%).

In infants who received a 2-dose series of MenACWY-TT administered at 6-7 months and 12-13 months of age, the most common adverse effects were tenderness (30-43%), erythema (21-22%), and swelling (15-16%) at the injection site; irritability (40-49%); abnormal crying (27-35%); drowsiness (28-37%); loss of appetite (15-17%); fever (9-13%); and vomiting (6-9%). In children 2 through 9 years of age, the most common adverse effects of MenACWY-TT following a primary dose were pain (39%), erythema (23%), and swelling (14%) at the injection site; myalgia (20%); malaise (21%); and headache (13%). In adolescents 10 through 17 years of age, the most common adverse effects of MenACWY-TT following a primary dose were injection site pain (35-45%), myalgia (27-35%), headache (27-30%), and malaise (19-26%).

In adults 18 through 55 years of age, the most common adverse effects of MenACWY-TT following a primary dose were injection site pain (42%), myalgia (36%), headache (29%), and malaise (23%). In adults 56 years of age or older, the most common adverse effects of MenACWY-TT following a primary dose were injection site pain (26%), myalgia (22%), headache (19%), and malaise (15%). Adverse effects reported following a booster dose of MenACWY-TT in adolescents and adults were comparable to those reported following primary immunization.

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 MENCYW-135 COMPONENT (meningococcal c,y,w-135,dip-conj vaccine component 2 of 2/pf):

Pediatric
Pregnant
Lactation
Geriatric

MenACWY-CRM: Safety and efficacy have not been established in children younger than 2 months of age. Safety and effectiveness of the 1-vial presentation of MenACWY-CRM have not been established in children younger than 10 years of age. Only the 2-vial presentation is approved for use in children 2 months through 9 years of age.

MenACWY-TT: Safety and efficacy have not been established in children younger than 6 weeks of age. Safety and efficacy have been established in children 6 weeks through 17 years of age. Apnea has been reported following IM administration of vaccines in some infants born prematurely. Decisions regarding when to administer an IM vaccine in infants born prematurely should be based on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

MenACWY-CRM: There are no adequate and well-controlled studies evaluating MenACWY-CRM in pregnant women in the US. A developmental toxicity study performed in female rabbits administered 0.5 mL of the vaccine (at each occasion) prior to mating and during gestation 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: There are no clinical studies evaluating MenACWY-TT in pregnant women. Available data on MenACWY-TT administered to pregnant women are insufficient to inform vaccine-associated risks.

A developmental toxicity study 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 states that MenACWY vaccine (MenACWY-CRM, MenACWY-TT) 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.

It is not known whether MenACWY-CRM or MenACWY-TT is distributed into human milk. Data are not available to assess the effects of MenACWY-CRM or MenACWY-TT on the breast-fed infant or on milk production/excretion. 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.

MenACWY-CRM: Safety and efficacy have not been established in adults 56 years of age or older+, including geriatric adults 65 years of age or older. However, ACIP states that MenACWY-CRM can be used when indicated in this age group. MenACWY-TT: A clinical study in adults 56 years of age or older included 249 vaccinees 65 years of age or older (71 of these were 75 years of age or older). The antibody response to all MenACWY vaccine serotypes was diminished in vaccine recipients 65 years of age or older compared with recipients 56-64 years of age.

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