Menveo Mencyw-135 Component (meningococcal C,Y,W-135,dip-conj vaccine component 1 of 2/PF)

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 is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*MenACWY-CRM (Menveo(R)): Severe allergic reaction (e.g., anaphylaxis) to any vaccine component or after previous dose of the vaccine or any vaccine containing diphtheria toxoid.

*MenACWY-TT (MenQuadfi(R)): Severe allergic reaction to any vaccine component or after a previous dose of the vaccine or any vaccine containing tetanus toxoid.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

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 no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

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.

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-TT is labeled by FDA for use in adults >=56 years of age, including those >=65 years of age. The manufacturer of MenACWY-TT makes no specific dosage recommendations for geriatric patients.

The manufacturer states that safety and efficacy of MenACWY-CRM have not been established in adults >=65 years of age. Although not labeled by FDA for use in adults >=56 years of age+, including those >=65 years of age, ACIP states that the vaccine can be used when primary or booster immunization is indicated in this age group.

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.