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Menactra

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Menactra

WARNINGS

Guillain-Barre syndrome (GBS) has been reported in temporal relationship following administration of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine. An evaluation of post-marketing adverse events suggests a potential for an increased risk of GBS following Menactra vaccination17 (see ADVERSE REACTIONS, Post-Marketing Reports section). Persons previously diagnosed with GBS should not receive Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine.

The stopper of the vial contains dry natural rubber latex, which may cause allergic reactions in latex-sensitive individuals. There is no latex in any component of the syringe.

The ACIP has published guidelines for vaccination of persons with recent or acute illness (refer to www.cdc.gov).15

PRECAUTIONS

General

Before administration, all appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient's previous immunization history, the presence of any contraindications to immunization, the current health status, and history concerning possible sensitivity to the vaccine, similar vaccine, or to latex.

As a precautionary measure, epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available in case of anaphylactic or serious allergic reactions.

Special care should be taken to avoid injecting the vaccine subcutaneously since clinical studies have not been conducted to establish safety and efficacy of the vaccine using this route of administration.

The immune response to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine administered to immunosuppressed persons has not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine has not been evaluated in animals for its carcinogenic or mutagenic potentials or for impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine. It is also not known whether Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well controlled studies in pregnant women. Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine should only be given to a pregnant woman if clearly needed. Assessment of the effects on animal reproduction has not been fully conducted with Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine as effects on male fertility in animals has not been evaluated. The effect of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine on embryo-fetal and pre-weaning development was evaluated in one developmental toxicity study in mice. Animals were administered Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine on Day 14 prior to gestation and during the period of organogenesis (gestation Day 6). The total dose given per time point was 0.1 mL/mouse via intramuscular injection (900 times the human dose, adjusted by body weight). There were no adverse effects on pregnancy, parturition, lactation or pre-weaning development noted in this study. Skeletal examinations revealed one fetus (1 of 234 examined) in the vaccine group with a cleft palate. None were observed in the concurrent control group (0 of 174 examined). There are no data that suggest that this isolated finding is vaccine related, and there were no vaccine related fetal malformations or other evidence of teratogenesis observed in this study. Health care providers are encouraged to register pregnant women who receive Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine in children below the age of 2 years have not been established.

Geriatric Use

Safety and effectiveness of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine in adults older than 55 years have not been established.

REFERENCES

15. CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR02):1-36.

18. CDC. Vaccine Adverse Event Reporting System - United States. MMWR 1990;39:730-733.

Last reviewed on RxList: 10/30/2007
This monograph has been modified to include the generic and brand name in many instances.

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