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Meningococcal Polysaccharide Vaccine (Groups A / C / Y and W-135)


General


Pronunciation

(me NIN joe kok al pol i SAK a ride vak SEEN groops aye, see, why & dubl yoo won thur tee fyve)


Brand Names: U.S.

  • Menomune-A/C/Y/W-135

Indications


Use: Labeled Indications

Meningococcal disease prevention: Active immunization of patients 2 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for persons at increased risk for meningococcal disease. Meningococcal quadrivalent conjugate vaccine (MenACWY; Menactra, Menveo) is preferred; meningococcal polysaccharide vaccine (MPSV4; Menomune) is preferred in meningococcal vaccine-naive adults ≥56 years of age requiring only a single vaccination (CDC/ACIP [Cohn 2013]).

Those at increased risk of meningococcal disease include the following:

- Persons ≥2 months of age with medical conditions such as anatomical or functional asplenia or persistent compliment component deficiencies (eg, C5-C9, properdin, factor H, or factor D)

- Persons ≥9 months of age that travel to or reside in countries where meningococcal disease is hyperendemic or epidemic, especially if contact with the local population will be prolonged

- Unvaccinated or incompletely vaccinated first year college students living in residence halls

- Military recruits

- Microbiologists with occupational exposure

- Persons (in all recommended age groups) at risk who are part of outbreaks caused by vaccine preventable serogroups


Contraindications


Hypersensitivity to any component of the formulation


Dosing and Administration


Dosing: Adult

Immunization: SubQ: 0.5 mL/dose

ACIP recommendations (CDC/ACIP [Cohn 2013]):

Adults <56 years: Not routinely recommended.

Adults ≥56 years: Meningococcal polysaccharide vaccine (MPSV4,Menomune) is preferred for meningococcal vaccine-naive persons in this age group who are at increased risk of meningococcal infection and require a single dose (eg, travelers or during a community outbreak). Persons previously vaccinated with a quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo, or Menactra) and who require revaccination or for whom multiple doses are anticipated, MenACWY-D (Menactra) is preferred (eg, persons with asplenia or microbiologists).


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Immunization: Children ≥2 years and Adolescents: SubQ: 0.5 mL/dose

ACIP recommendations (CDC/ACIP [Cohn 2013]): Children and Adolescents: Not routinely recommended.


Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer 's labeling.


Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer 's labeling.


Reconstitution

Reconstitute using provided diluent; shake well. Use single-dose vial immediately after reconstitution. Use multidose vial within 35 days of reconstitution.


Administration

Administer by SubQ injection to the deltoid region; do not administer intradermally, IM, or IV. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering persons name, title, and address be entered into the patient's permanent medical record.


Storage

Prior to and following reconstitution, store vaccine and diluent at 2 ‚ °C to 8 ‚ °C (35 ‚ °F to 46 ‚ °F); do not freeze.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, powder for reconstitution [MPSV4]:

Menomune-A/C/Y/W-135: 50 mcg each of polysaccharide antigen groups A, C, Y, and W-135 per 0.5 mL dose [contains lactose 2.5-5 mg/0.5 mL, natural rubber/natural latex in packaging, thimerosal in diluent for multidose vial]


Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.


Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy


Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.


Adverse Reactions


>10%:

Central nervous system: Headache (29% to 42%), fatigue (children ≥11 years, adolescents, and adults: 25% to 32%), malaise (children ≥11 years, adolescents, and adults: 17% to 22%), irritability (children 2 to 10 years: 12%), drowsiness (children 2 to 10 years: 11%)

Gastrointestinal: Diarrhea (10% to 14%)

Local: Pain at injection site (adults: 48%; children and adolescents 2 to 18 years: 26% to 29%), erythema at injection site (adults: 16%; children and adolescents 2 to 18 years: 6% to 8%), induration at injection site (4% to 11%)

Neuromuscular & skeletal: Arthralgia (adults: 16%; children and adolescents 2 to 18 years: 5% to 10%)

1% to 10%:

Central nervous system: Chills (children ≥11 years, adolescents, and adults: 4% to 6%)

Dermatologic: Skin rash (children and adolescents 2 to 18 years: 1% to 3%; adults: <1%)

Gastrointestinal: Anorexia (8% to 10%), vomiting (1% to 3%)

Local: Swelling at injection site (3% to 8%)

Miscellaneous: Fever (children and adolescents 2 to 18 years: 3% to 5%; adults: <1%)

Postmarketing and/or case reports: Guillain-Barre syndrome, hypersensitivity (angioedema, dyspnea, pruritus, rash, urticaria), vasodepressor syncope


Warnings/Precautions


Concerns related to adverse effects:

- Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).

- Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

Disease-related concerns:

- Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever).

- Meningococcal infections: Not to be used to treat meningococcal infections or to provide immunity against N. meningitidis serogroup B.

Concurrent drug therapy issues:

- Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NCIRD/ACIP 2011).

Special populations:

- Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

Dosage form specific issues:

- Latex: Packaging may contain natural latex rubber.

- Thimerosal: Some dosage forms contain thimerosal.

Other warnings/precautions:

- Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

- Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cerebrospinal fluid leaks, cochlear implants, or sickle cell disease are available from the IDSA (Rubin 2014).

- Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).


Pregnancy Risk Factor

C


Pregnancy Considerations

Animal reproduction studies have not been conducted. Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011). Pregnancy should not preclude vaccination if indicated (CDC/ACIP [Cohn 2013]).


Actions


Pharmacology

Induces the formation of bactericidal antibodies to meningococcal antigens; the presence of these antibodies is strongly correlated with immunity to meningococcal disease caused by Neisseria meningitidis groups A, C, Y and W-135.


Onset of Action

Antibody levels: 7-10 days


Duration of Action

Antibodies against group A and C polysaccharides decline markedly (to prevaccination levels) over the first 3 years following a single dose of vaccine, especially in children <4 years of age


Patient and Family Education


Patient Education

- Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience injection site pain or irritation, headache, loss of strength and energy, joint pain, lack of appetite, diarrhea, irritability (children), or fatigue (children) (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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