meningococcal ABCWY pentavalent vaccine

Meningococcal ABCWY pentavalent vaccine is administered to protect a person from meningococcal disease caused by the bacteria Neisseria meningitidis serogroups A, B, C, W, and Y. Meningococcal disease is a severe, and sometimes, life-threatening bacterial infection of the lining of the brain, spinal canal, and the bloodstream. There are at least 13 strains of N. Meningitidis, but serogroups A, B, C, W, X and Y account for a majority of invasive disease and among these, B, C and Y are the most prevalent in the United States.

Meningococcal disease can affect anyone, even healthy individuals, and turn fatal within 24 hours. It is, however, more common in children younger than 1 year old, young adolescents and adults 16-23 years old, and adults above 65 years and older. Meningococcal ABCWY pentavalent vaccine is administered as two intramuscular injections 6 months apart in individuals of age 10 to 25 years.

N. meningitidis lives in the nose and throat of approximately 10% of the population without causing disease. N. meningitidis is transmitted through saliva and nasal droplets of a carrier and can cause invasive disease in others who are vulnerable due to age, medical conditions, compromised immunity or other factors. The bacteria get into the bloodstream, cross the blood-brain barrier and infect the membranes of the brain and spinal cord.

Meningococcal ABCWY pentavalent vaccine is an inactivated bacterial vaccine prepared from protein and carbohydrate fragments of A, B, C, W and Y strains of N. meningitidis grown in culture, purified and killed (inactivated) to prevent them from causing disease. Meningococcal ABCWY pentavalent vaccine stimulates the immune system to produce antibodies that recognize the N. meningitidis bacterial molecules (antigens), and attack and kill them, protecting the vaccinated individual from severe disease if exposed to the bacteria in the future.

Meningococcal ABCWY pentavalent vaccine is conjugated with a tetanus bacterial toxoid used as a carrier protein and to enhance immune response. Toxoids are toxins that are chemically altered to eliminate the toxicity, but can be recognized as bacterial antigens by the immune system. The vaccine does not contain any preservatives.

• Do not administer meningococcal ABCWY pentavalent vaccine to anyone with a history of severe allergic reactions (anaphylaxis) to any component of the formulation.
• Administer meningococcal ABCWY pentavalent vaccine only as an intramuscular injection. Do not use any other route to administer.
• Meningococcal ABCWY pentavalent vaccine should be administered only in a clinical setting where medical facilities and trained personnel are readily available to manage severe reactions, should they occur.
• Injectable vaccines, including meningococcal ABCWY pentavalent vaccine, can cause fainting. Precautions should be taken when administering the vaccine to prevent falling and injury.
• Individuals with altered immunocompetence may have reduced immune response to the meningococcal ABCWY pentavalent vaccine.
• There is an increased risk of developing invasive disease from N. meningitidis serogroups A, B, C, W, and Y, despite development of antibodies in individuals:
  • With certain deficiencies in the complement system, a part of the immune system that enhances the ability of antibodies to kill pathogens.
  • Taking treatment that inhibits terminal complement system activation.
• Vaccination with meningococcal ABCWY pentavalent vaccine may not protect 100% of recipients from invasive disease.
• Meningococcal ABCWY pentavalent vaccine cannot prevent tetanus, and cannot substitute for a tetanus vaccination.
• There have been unexpected reports of Guillain-Barré syndrome (GBS), a rare disorder in which the immune system attacks the peripheral nerves, with the use of another meningococcal vaccine. Consider benefits and risks before administering meningococcal ABCWY pentavalent vaccine to individuals with a history of GBS.

Common side effects of meningococcal ABCWY pentavalent vaccine include:

• Injections site reactions including:
  • Pain
  • Redness (erythema)
  • Swelling
• Fatigue
• Headache
• Muscle pain
• Joint pain
• Chills
• Fever
• Vomiting
• Diarrhea

Less common side effects of meningococcal ABCWY pentavalent vaccine include:

• Allergic reactions
• Severe allergic reactions (anaphylaxis)
• Fainting (syncope)

Call your doctor immediately if you experience any of the following symptoms or serious side *effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Lyophilized powder for reconstitution

• 0.5 mL suspension for intramuscular (IM) injection after reconstitution
• Supplied as kit that includes lyophilized MenACWY component, a prefilled syringe containing the MenB component, and a vial adapter

Adult and Pediatric:

Meningococcal Vaccination

• Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, Y, and W-135 in persons aged 10-25 years
• 2 dose series: 0.5 mL IM administered 6 months apart

Overdose

There are no reports of overdose with meningococcal ABCWY pentavalent vaccine. Overdose is unlikely to occur because the vaccine comes with the recommended doses in a kit and is administered in a clinical setting.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

Meningococcal ABCWY pentavalent vaccine has no listed severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• No developmental toxicity studies have been performed with the use of meningococcal ABCWY pentavalent vaccine during pregnancy. There are no clinical studies on the use of the vaccine in pregnant women to determine a vaccine-associated risk to the fetus.
• There are no data on the presence of meningococcal ABCWY pentavalent vaccine in breastmilk, or its effect on milk production or the breastfed infant.
• Decision to breastfeed should be made after considering the developmental and health benefits of breastfeeding, along with the potential adverse effects to the infant from the vaccine or the mother’s susceptibility to contracting the disease that the vaccine prevents.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to meningococcal ABCWY pentavalent vaccine during pregnancy. Individuals who received the vaccine during pregnancy are encouraged to contact, or have their healthcare provider contact, 1-877-390-2953 to enroll in or obtain information about the registry.