Menactra®

/ Medici

Preparation for Administration: Menactra is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered. Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.
Dose and Schedule: Menactra is administered as a 0.5 mL dose by intramuscular injection.
Do not administer this product intravenously or subcutaneously.
Primary Vaccination:
– In children 9 through 23 months of age, Menactra is given as a 2-dose series three months apart.
– Individuals 2 through 55 years of age, Menactra is given as a single dose.
Booster Vaccination:
– A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.

Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitides serogroup B disease.

Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide, diphtheria toxoid- or CRM197-containing vaccine, or to any component of Menactra.

Guillain-Barré Syndrome: Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS following receipt of Menactra. The decision to give Menactra should take into account the potential benefits and risks.
GBS has been reported in temporal relationship following administration of Menactra.
The risk of GBS following Menactra vaccination was evaluated in a post- marketing retrospective cohort study.
Preventing and Managing Allergic Vaccine Reactions: Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks.
Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Thrombocytopenia or Bleeding Disorders: Menactra has not been evaluated in persons with thrombocytopenia or bleeding disorders. As with any other vaccine administered intramuscularly, the vaccine risk versus benefit for persons at risk of hemorrhage following intramuscular injection must be evaluated.
Altered Immunocompetence:
• Reduced Immune Response: Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to Menactra.
• Complement Deficiency: Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, even if they develop antibodies following vaccination with Menactra.
Limitations of Vaccine Effectiveness: Menactra may not protect all recipients.
Because of the decrease in immunogenicity with parallel immunization of Pneumovax it is not recommended to give both vaccines together.
Syncope: Syncope (fainting) has been reported following vaccination with Menactra. Procedures should be in place to prevent falling injury and manage syncopal reactions.

The most frequently reported solicited injection site and systemic adverse reactions in US children aged 2-10 years of age (Table 2) were injection site pain and irritability. Diarrhea, drowsiness, and anorexia were also common.
The most commonly reported solicited injection site and systemic adverse reactions in adolescents, ages 11-18 years (Table 3), and adults, ages 18-55 years (Table 4), after a single dose were injection site pain, headache and fatigue. Except for redness in adults, injection site reactions were more frequently reported after Menactra vaccination than after Menomune – A/C/Y/W-135 vaccination.
See prescribing information for full details.

Concomitant Administration with Other Vaccines: Menactra vaccine was concomitantly administered with Typhim Vi® [Typhoid Vi Polysaccharide Vaccine] (Typhoid) and Tetanus and Diphtheria Toxoids Adsorbed, For Adult Use (Td) vaccine, in individuals 18 through 55 and 11 through 17 years of age, respectively. In children 4 through 6 years of age, Menactra was co-administered with DAPTACEL, and in children younger than 2 years of age, Menactra was coadministered with one or more of the following vaccines: PCV7, MMR, V, MMRV, or HepA.
When Menactra and DAPTACEL are to be administered to children 4 through 6 years of age, preference should be given to simultaneous administration of the 2 vaccines or administration of Menactra prior to DAPTACEL. Administraton of Menactra one month after DAPTACEL has been shown to reduce meningococcal antibody responses to Menactra. Data are not available to evaluate the immune response to Menactra administered to younger children following DAPTACEL or to Menactra administered to persons <11 years of age following other diphtheria toxoid-containing vaccines.
Pneumococcal antibody responses to some serotypes in PCV7 were decreased following co- administration of Menactra and PCV7.
Do not mix Menactra with other vaccines in the same syringe. When Menactra is administered concomitantly with other injectable vaccines, the vaccines should be administered with different syringes and given at separate injection sites.
Immunosuppressive Therapies: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) may reduce the immune response to vaccines.

Pregnancy: Since there are no data on the use of this vaccine in pregnant women, Menactra vaccine should be given to a pregnant woman only if clearly needed, such as during an outbreak or prior to necessary travel to an endemic area, and only following an assessment involving the healthcare professional and patient of the risks and benefits.
Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Menactra and any potential adverse effects on the breastfed child from Menactra. Data are not available to assess the effects of Menactra on the breastfed infant or on milk production/excretion.
See prescribing information for full details.

Storage: Store at 2° to 8°C. DO NOT FREEZE. Product that has been exposed to freezing should not be used.