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Menomune

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Menomune

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Latex

The stoppers to the vials of lyophilized vaccine and diluent contain dry natural latex rubber that may cause allergic reactions in latex sensitive persons.

Management Of Acute Allergic Reactions

Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of the vaccine.

Moderate Or Severe Acute Illness

To avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects, vaccination with Menomune - A/C/Y/W-135 vaccine should be postponed in persons with moderate or severe acute illness.4

Limitations Of Vaccine Effectiveness

Menomune - A/C/Y/W-135 vaccine may not protect all recipients.

Altered Immunocompetence

Persons who are immunosuppressed, including persons receiving immunosuppressive therapy, may have a diminished immune response to Menomune - A/C/Y/W-135 vaccine [see DRUG INTERACTIONS].

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Menomune -A/C/Y/W-135 vaccine. It is also not known whether Menomune - A/C/Y/W-135 vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Menomune - A/C/Y/W-135 vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Menomune - A/C/Y/W-135 vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menomune - A/C/Y/W-135 vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Menomune - A/C/Y/W-135 vaccine in children below the age of 2 years have not been established.

During a meningococcal serogroup A epidemic in sub-Saharan Africa, children 3 months to 16 years of age were vaccinated with a high molecular weight serogroup A/C meningococcal polysaccharide vaccine. In case-control studies, after 1 year of observation, vaccine efficacy against meningococcal serogroup A disease was estimated to be 87% [90% Confidence Interval (CI), 52% to 96%], overall. After 3 years, efficacy was estimated to be 67% (90% CI, 40% to 82%) among children who were 4-16 years of age at the time of vaccination and 8% (90% CI, -102% to 58%) among children who were 1-3 years of age at the time of vaccination.5

The efficacy of a serogroup C meningococcal vaccine in infants and young children was evaluated in a placebo-controlled trial during a serogroup C epidemic in Brazil. Vaccine efficacy was estimated to be 12% (95% CI, -55% to 62%) among children 6 to 23 months of age and 55% (95% CI, -4% to 72%) among children 24 to 36 months of age.6

Geriatric Use

Clinical studies of Menomune - A/C/Y/W-135 vaccine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

REFERENCES

4 Recommendations of the Advisory Committee on Immunization Practices (ACIP) General Recommendations on Immunization. MMWR 2006 December 01;55(RR15):1-48.

5 Reingold AL, et al. Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine. Lancet. 1985;No.8447:114-118.

6 Granoff DM, et al. Meningococcal vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008:399-434.

Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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