Meningococcal Vaccine

Trade Names:Menactra- Injection 48 mcg

Trade Names:Menomune-A/C/Y/W-135- Injection 50 mcg

Pharmacology

Induces production of bactericidal antibodies specific to capsular polysaccharides of serogroups A, C, Y, and W-135.

Indications and Usage

Active immunization of children and adults 2 to 55 yr of age against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

Active immunization against invasive meningococcal disease caused by serogroups A, C, Y, and W-135; may be used to prevent and control outbreaks of serogroup C meningococcal disease.

Contraindications

Hypersensitivity to dry natural rubber latex; hypersensitivity to any component of the product, including diphtheria toxoid; known history of Guillain-Barré syndrome; life-threatening reaction after previous administration of a vaccine containing similar components.

Known sensitivity to thimerosal or any component of the vaccine. Defer immunization during any acute illness.

Dosage and Administration

IM Single 0.5 mL dose, preferably in the deltoid region.

Subcutaneous Single 0.5 mL dose. Revaccination with a single 0.5 mL dose may be indicated for persons at high risk of infection, particularly children who were first vaccinated when they were younger than 4 yr of age.

General Advice

• Do not mix meningococcal vaccine with any vaccine in the same syringe. Separate injection sites and different syringes should be used in case of coadministration.
• Menactra is for IM use only. Do not administer IV, subcutaneously, or intradermally.
• Menomune is for subcutaneous use only. Do not administer IM, IV, or intradermally.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Protect from freezing. Do not use vaccine if it has been frozen.

Store at 35° to 46°F. Discard remainder of multidose vials within 35 days of reconstitution. Use single-dose vial within 30 min after reconstitution.

Drug Interactions

An adequate immunologic response may not be obtained.

Do not coadminister with Menomune because of combined endotoxin content.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (42%); fatigue (35%); malaise (24%); irritability (12%); drowsiness (11%); acute disseminated encephalomyelitis, facial palsy, Guillain-Barré Syndrome, transverse myelitis, vasovagal syncope (postmarketing).

Dermatologic

Rash (3%); urticaria (postmarketing).

GI

Diarrhea (16%); anorexia (12%); vomiting (3%).

Local

Pain (59%); tenderness (36%); redness (22%); induration (19%); swelling (17%); erythema (4%).

Musculoskeletal

Arthralgia (20%); myalgia (postmarketing).

Miscellaneous

Chills (10%); fever (5%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 2 yr of age.

Elderly

Safety and efficacy not established in adults older than 55 yr of age.

Hypersensitivity

Vaccine and vaccine components can cause hypersensitivity reactions.

Guillain-Barré Syndrome

Risk of Guillain-Barré Syndrome following Menactra vaccination may be increased. Persons with a history of Guillain-Barré Syndrome should not receive Menactra vaccine.

Latex

Dry natural latex rubber is contained in the vial stopper.

Patient Information

• Advise patient or caregiver that vaccine will be prepared and administered by health care provider.
• Review potential benefits and risks of vaccine with patient or caregiver and provide vaccine information statements for review.
• Advise patient or caregiver that pain at the injection site, headache, fever, general body discomfort, and joint pain can occur, and to use nonnarcotic analgesic and antipyretic (eg, ibuprofen) agents for symptomatic relief. Advise patient or caregiver to report severe, persistent, or unusual or unexplained symptoms to health care provider.

Copyright © 2009 Wolters Kluwer Health.