meningococcal A C Y and W-135 diphtheria conjugate vaccine (Rx)

Brand and Other Names:Menactra, Menveo
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

IM solution

  • 0.5 mL/single-dose vial (Menactra)
  • 0.5 mL/1-vial presentation (Menveo)
  • 0.5 mL/2-vial presentation (Menveo)*
  • *2-vial presentation combines Vial 1 (gray cap) containing the MenCYW-135 liquid conjugate component and Vial 2 (orange cap) containing the MenA lyophilized conjugate to form a single dose (0.5 mL)

Meningococcal Vaccination

Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals

0.5 mL/dose IM

Menveo (1-vial or 2-vial presentation) or Menactra

  • All formulations: 0.5 mL/dose IM x 1 dose
  • Booster (15-55 years): 0.5 mL IM x 1 dose to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose

Menactra

  • 2-55 years: 0.5 mL IM x 1 dose
  • Booster (15-55 years): Administer 0.5 mL to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose

CDC recommendations for special situations

  • https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
  • Anatomical or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (eg, eculizumab, ravulizumab) use: 2-dose series of Menactra or Menveo at least 8 weeks apart and revaccinate every 5 years if risk remains
  • Travel in countries with hyperendemic or epidemic meningococcal disease, or microbiologists routinely exposed to Neisseria meningitidis: 1 dose Menactra, or Menveo and revaccinate every 5 years if risk remains
  • First-year college students who live in residential housing (if not previously vaccinated at age ≥16 years or older) or military recruits: 1 dose Menactra or Menveo

Dosing Considerations

No prevention against N. meningitidis serogroup B infections

Menveo

  • Supplied as 1-vial or 2-vial presentation

Dosage Forms & Strengths

IM solution

  • 0.5 mL/single-dose vial (Menactra)
  • 0.5 mL/1-vial presentation (Menveo)
  • 0.5 mL/2-vial presentation (Menveo)*
  • *2-vial presentation combines Vial 1 (gray cap) containing the MenCYW-135 liquid conjugate component and Vial 2 (orange cap) containing the MenA lyophilized conjugate to form a single dose (0.5 mL)

Meningococcal Vaccination

Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months to 55 years of age (Menveo) or 9 months to 55 years of age (Menactra)

0.5 mL/dose IM

CDC recommendations

  • Dose 1 at age 11-12 years
  • Dose 2 (booster) at age 16 years
  • Also see CDC Immunization Schedules
  • Catch-up vaccination
    • Dose 1 at 13-15 years
    • Dose 2 (booster) at 16-18 years (at least 8 weeks after initial dose)

Menveo (2-vial presentation)

  • Initiated at 2 months: 4-dose series at 2, 4, 6, and 12 months of age
  • Initiated at 7-23 months: 2-dose series with second dose administered in second year of life and at least 3 months after first dose
  • Initiated at 2-10 years: 0.5 mL IM x 1 dose; for children aged 2-5 years at continued high risk of meningococcal disease, administer second dose 2 months after first dose
  • Initiated at 12-18 years: 0.5 mL IM x 1 dose
  • Booster (15-18 years): Administer 0.5 mL using either one-vial or two-vial presentation to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose

Menactra

  • Initiated at 9-23 months: 2-dose series with second dose administered in second year of life and at least 3 months after first dose
  • Initiated at 2-18 years: 0.5 mL IM x 1 dose
  • Booster (15-18 years): Administer 0.5 mL to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose

High-risk condition

  • https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
  • Includes anatomic or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (eg, eculizumab, ravulizumab) use
  • Menveo
    • Initiated at 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months)
    • Initiated at 3-6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until dose is received at ≥7 months, followed by an additional dose at least 12 weeks later and after 12 months)
    • Initiated at 7-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months)
    • Initiated at ≥24 months: 2-dose series at least 8 weeks apart
  • Menactra (9-23 months)
    • Persistent complement component deficiency or complement inhibitor use: 2-dose series at least 12 weeks apart
    • Anatomic or functional asplenia, sickle cell disease, or HIV infection: Not recommended
  • Menactra (≥2 years)
    • Anatomic or functional asplenia, sickle cell disease, HIV infection, persistent complement component deficiency or complement inhibitor use: 2-dose series at least 8 weeks apart
    • Must be administered at least 4 weeks after completion of PCV13 series

Travel in countries with hyperendemic or epidemic meningococcal disease, including countries in the African meningitis belt or during the Hajj

  • Based on CDC recommendations
  • Menveo (2–23 months)
    • Initiated at 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months)
    • Initiated at 3-6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until dose is received at ≥7 months, followed by an additional dose at least 12 weeks later and after 12 months)
    • Initiated at 7-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months)
    • Initiated at ≥24 months: 0.5 mL IM x 1 dose
  • Menactra
    • Initiated at 9-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1; dose 2 may administer as early as 8 weeks after dose 1 in travelers
    • Initiated at ≥2 years: 1 dose
    • First-year college students who live in residential housing (if not previously vaccinated at age ≥16 years) or military recruits H5
    • Menveo or Menactra: 1 dose

Dosing Considerations

No prevention against N. meningitidis serogroup B infections

Menveo

  • Supplied as 1-vial or 2-vial presentation

Safety and efficacy of Menactra and Menveo not established in adults aged >55 yr (Menomune A/C/Y/W-135 recommended for 1 time doses in travelers)

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Adverse Effects

>10%

Menveo

  • 7-9 months
    • Erythema >50 mm (15%)
    • Tenderness, severe (11%)
  • 12 months
    • Erythema >50 mm (13%)
  • 2-5 years
    • Injection site pain, any (33%)
    • Erythema, any (27%)
    • Irritability, any (21%)
    • Induration, any (18%)
    • Sleepiness, any (16%)
  • 6-10 years
    • Injection site pain (39%)
    • Erythema (28%)
    • Headache (18%)
    • Induration (17%)
    • Malaise (14%)

Menactra

  • 2-5 years
    • Injection site pain, any (35%)
    • Erythema, any (25%)
    • Irritability, any (22%)
    • Induration, any (18%)
    • Sleepiness, any (18%)
  • 6-10 years
    • Injection site pain, any (45%)
    • Erythema, any (22%)
    • Induration, any (13%)
    • Headache, any (13%)
    • Malaise, any (11%)

1-10%

Menveo

  • 7-9 months
    • Induration >50 mm (ages 7-9 months) (8%)
  • 12 months
    • Tenderness, severe (10%)
    • Induration >50 mm (8%)
  • 2-5 years
    • Change in eating, any (9%)
    • Diarrhea, any (7%)
    • Injection site pain, moderate (6%)
    • Irritability, moderate (6%)
    • Erythema, moderate (5%)
    • Headache, any (5%)
    • Rash, any (4%)
    • Sleepiness, moderate (3%)
    • Induration, moderate (2%)
    • Fever, any (2%)
    • Injection site pain, severe (1%)
    • Erythema, severe (1%)
    • Irritability, severe (1%)
    • Sleepiness, severe (1%)
    • Change in eating, severe (1%)
    • Diarrhea, moderate (1%)
    • Headache, moderate (1%)
    • Arthralgia, moderate (1%)
    • Vomiting, moderate (1%)
  • 6-10 years
    • Myalgia, any (10%)
    • Nausea, any (8%)
    • Arthralgia, any (6%)
    • Chills, any (5%)
    • Rash, any (5%)
    • Headache, moderate (3%)
    • Malaise, moderate (3%)
    • Myalgia, moderate (2%)
    • Nausea, moderate (2%)
    • Fever, any (2%)
    • Headache, severe (1%)
    • Malaise, severe (1%)
    • Myalgia, severe (1%)
    • Nausea, severe (1%)
    • Arthralgia, moderate (1%)
    • Chills, moderate (1%)
    • Fever, moderate (1%)

Menactra

  • 2-5 years
    • Change in eating, any (10%)
    • Injection site pain, moderate (8%)
    • Diarrhea, any (8%)
    • Irritability, moderate (7%)
    • Headache, any (6%)
    • Sleepiness, moderate (5%)
    • Rash, any (5%)
    • Erythema, moderate (3%)
    • Induration, moderate (2%)
    • Change in eating, moderate (2%)
    • Fever, any (2%)
    • Irritability, severe (1%)
    • Sleepiness, severe (1%)
    • Diarrhea, moderate (1%)
    • Headache, moderate (1%)
    • Arthralgia, moderate (1%)
    • Vomiting, moderate (1%)
  • 6-10 years
    • Myalgia, any (10%)
    • Injection site pain, any (10%)
    • Nausea, any (6%)
    • Chills, any (5%)
    • Arthralgia, any (4%)
    • Rash, any (3%)
    • Malaise, moderate (3%)
    • Injection site pain, severe (2%)
    • Erythema, moderate (2%)
    • Induration, moderate (2%)
    • Headache, moderate (2%)
    • Myalgia, moderate (2%)
    • Nausea, moderate (2%)
    • Headache, severe (1%)
    • Malaise, severe (1%)
    • Myalgia, severe (1%)
    • Arthralgia, moderate (1%)
    • Chills, moderate (1%)

<1%

Menveo

  • 2-5 years
    • Induration, severe (0.4%)
    • Fever, moderate (0.4%)
    • Diarrhea, severe (0.1%)
    • Arthralgia, severe (0.1%)
    • Vomiting, severe (0.1%)

Menactra

  • 2-5 years
    • Injection site pain, severe (0.4%)
    • Erythema, severe (0.3%)
    • Induration, severe (0.3%)
    • Change in eating, severe (0.3%)
    • Headache, severe (0.3%)
    • Fever, moderate (0.3%)
  • 6-10 years
    • Nausea, severe (0.4%)
    • Arthralgia, severe (0.4%)
    • Chills, severe (0.4%)
    • Fever, severe (0.4%)
    • Erythema, severe (0.2%)

Postmarketing Experience

Blood and lymphatic system disorders: Local lymphadenopathy

Ear and labyrinth disorders: Hearing impaired, ear pain, vertigo, vestibular disorder

Eye disorders: Eyelid ptosis

General disorders and administration site conditions: Injection site pruritus; pain; erythema; inflammation; and swelling, including extensive swelling of the vaccinated limb; fatigue; malaise; pyrexia

Immune system disorders: Hypersensitivity reactions, including anaphylaxis

Infections and infestations: Vaccination site cellulitis

Injury, poisoning, and procedural complications: Fall, head injury

Investigation: ALT increased; body temperature increased

Musculoskeletal and connective tissue disorders: Arthralgia, bone pain

Nervous system disorders: Dizziness, syncope, tonic convulsion, headache, facial paresis, balance disorder

Respiratory, thoracic, and mediastinal disorders: Oropharyngeal pain

Skin and SC tissue disorders: Skin exfoliation

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Warnings

Contraindications

History of severe allergic reaction (eg, anaphylaxis) to any component of vaccine, or to any other diphtheria toxoid-containing vaccine

Cautions

Ensure appropriate medical treatment is available should an allergic reaction (eg, anaphylactic reaction) occurs

Syncope reported; place proper protocols to avoid injury from syncope

Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to drug

Certain complement deficiencies and treatments that inhibit terminal complement activation (eg, eculizumab) may increase the patient’s risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and 20 W-135, even if antibodies develop following vaccination

Persons previously diagnosed with Guillain-Barre syndrome (GBS) may be at increased risk of GBS following therapy; consider the potential benefits and risks before administering; GBS has been reported in temporal relationship following administration of therapy

Apnea observed in some infants born prematurely; consider the potential benefits and risks before administering in premature infants

Drug interaction overview

Other vaccines
  • Do not mix meningococcal vaccine or any of its components with any other vaccine or diluent in same syringe or vial
Immunosuppressives
  • Immunosuppressive therapies, such as irradiation, antimetabolite medications, alkylating agents, cytotoxic drugs, and corticosteroids (when used in greater than physiologic doses) may reduce immune response to vaccine
  • Not evaluated in persons receiving such therapies

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant females

Available data do not suggest an increased risk of major birth defects and miscarriage in females who received vaccine within 28 days before conception or during pregnancy

Animal data

  • A developmental toxicity study was performed in female rabbits administered 0.5 mL (at each occasion) before mating and during gestation
  • This study revealed no adverse effects on fetal or preweaning development

Lactation

It is not known whether the vaccine components are excreted in human milk

Data are not available to assess effects of vaccine in breastfed infant or on milk production/excretion

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Presence of bacteriocidal anti-capsular meningococcal antibodies associated with protection from invasive meningococcal disease

Meningococcal serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein carrier

Induces production of bactericidal antibodies directed against the capsular polysaccharides of serogroups A, C, Y and W-135

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Administration

Preparation

  • Menactra

    • Withdraw 0.5 mL from vial
  • Menveo (1-vial presentation)

    • No reconstitution required
    • Withdraw 0.5 mL from vial (pink cap)
  • Menveo (2-vial presentation)

    • Withdraw contents of Vial 1 (gray cap) and reconstitute Vial 2 (orange cap)
    • Invert Vial 2 and shake well until lyophilized conjugate is fully dissolved
    • Once reconstituted, withdraw 0.5 mL from vial containing reconstituted vaccine
    • Administer immediately or store at 36-77ºF (2-25ºC) for up to 8 hr

IM Administration

Menveo: Solution appears clear, colorless, free from visible foreign particles

Menactra: Solution is a clear to slightly turbid solution

Visually inspect parenteral drug products and discard if solution contains particulate matter or appears discolored before administering

Administer as IM injection only

Do not administer IV or SC

Storage

Menactra

  • Do NOT freeze; discard frozen/previously frozen product
  • Unopened: Refrigerate at 36-46ºF (2-8ºC); discard after expiration date
  • Discard any unused portion

Menveo 1-vial presentation (pink-cap vial)

  • Do NOT freeze; discard frozen/previously frozen product
  • Unopened: Refrigerate at 36-46ºF (2-8ºC); protect from light; maintain vaccine at 36-46ºF (2-8ºC) during transport; discard after expiration date
  • During transport: Refrigerate at 36-46°F (2-8ºC)

Menveo 2-vial presentation

  • Do NOT freeze; discard frozen/previously frozen product
  • Unopened: Refrigerate at 36-46ºF (2-8ºC); protect from light; maintain vaccine at 36-46ºF (2-8ºC) during transport; discard after expiration date
  • Reconstituted vaccine: Store at 36-77ºF (2-25ºC) for up to 8 hr; discard if frozen or not used within 8 hr
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Menactra (PF) intramuscular
-
4 mcg/0.5 mL vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
meningococcal vaccine A,C,Y,W-135 diph conj(PF)intramuscular

MENINGOCOCCAL VACCINE - INJECTION

(MEN-in-go-COC-al)

COMMON BRAND NAME(S): Menactra, Menveo, Trumenba

USES: This vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). This infection may cause severe problems (hearing loss, brain/nerve problems, paralysis, blindness, seizures, loss of limbs) even with antibiotic treatment. This vaccine works by increasing the body's natural defense (immunity) against the bacteria that cause meningococcal disease.Vaccination is the best way to prevent infection. However, like any vaccine, it may not fully protect everyone who receives it.The brand and dose of vaccine you receive depend on your age. Other vaccines may also be given at the same time, usually in a different site on the body.

HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This vaccine is given by injection into a muscle by a health care professional. Adults and children usually receive the injection in the upper arm, and infants receive it in the upper thigh. Depending on your age, the vaccine is given one or more times. Ask your health care professional for your recommended vaccine schedule.Since fever may commonly occur after vaccination (especially in infants and children), your health care professional may recommend a fever/pain relief medication (such as acetaminophen) for use if needed. Ask your health care professional for details.

SIDE EFFECTS: Pain/redness/swelling at the injection site, headache, fever, chills, drowsiness, tiredness, joint/muscle pain, nausea, loss of appetite, or diarrhea may occur. If any of these effects last or get worse, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that this medication has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your health care professional right away if you have any serious side effects, including: numbness/tingling, muscle weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

PRECAUTIONS: Before receiving this vaccine, tell your health care professional if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in some brands), which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before receiving this vaccine, tell your health care professional your medical history, especially of: current fever/illness, a certain nerve disease (Guillain-Barre syndrome), immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment).This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits with your health care professional.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).

OVERDOSE: Not applicable.

NOTES: Keep vaccine records for yourself and your children. After your children are grown, give them a record to share with their health care professionals to help prevent unnecessary re-vaccinations.

MISSED DOSE: It is important that you or your child receive each vaccination as scheduled. Be sure to ask when each dose should be received, and make a note on a calendar to help you remember.

STORAGE: Store in the refrigerator. Do not freeze. Different brands of this medication may have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.