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

>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

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

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.

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

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