Meningococcal ABCWY Pentavalent Vaccine

Meningococcal ABCWY Pentavalent Vaccine is 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 to 25 years.

• Meningococcal ABCWY Pentavalent Vaccine is available under the following different brand names: Penbraya

Common side effects of Meningococcal ABCWY Pentavalent Vaccine include:

• pain at the injection site
• fatigue
• headache
• injection site redness
• muscle pain
• injection site swelling
• joint pain, and chills

Serious side effects of Meningococcal ABCWY Pentavalent Vaccine include:

• not available

Rare side effects of Meningococcal ABCWY Pentavalent Vaccine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

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

Adult and pediatric dosage

Lyophilized powder for reconstitution

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

Meningococcal vaccination

Adult and pediatric dosage

• 2 dose series: 0.5 mL IM administered 6 months apart

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Meningococcal ABCWY Pentavalent Vaccine has no noted severe interactions with any other drugs
• Meningococcal ABCWY Pentavalent Vaccine has no noted serious interactions with any other drugs
• Meningococcal ABCWY Pentavalent Vaccine has no noted moderate interactions with any other drugs
• Meningococcal ABCWY Pentavalent Vaccine has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Meningococcal ABCWY Pentavalent Vaccine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Meningococcal ABCWY Pentavalent Vaccine?”

Cautions

• Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an anaphylactic reaction occurs following administration
• Syncope may occur in association with administration of injectable vaccines; procedures should be in place to avoid injury from fainting
• Vaccination with MenABCWY does not substitute for vaccination with a tetanus toxoid-containing vaccine to prevent tetanus (lyophilized MenACWY polysaccharides individually conjugated to TT)
• Guillain-Barré syndrome (GBS) reported in temporal relationship following administration of another meningococcal quadrivalent polysaccharide conjugate vaccine; consider the expected benefits and potential risks when administering to persons with a history of GBS
• Vaccination may not protect all vaccine recipients
• Altered immunocompetence
  • Some individuals with altered immunocompetence may have reduced immune responses to vaccines
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination

Pregnancy and Lactation

• Available human data on the vaccine administered to pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy
• There were no developmental toxicity studies performed
• Pregnancy registry
  • Individuals who received the MenABCWY 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
• Lactation
  • There are no data available to assess the effects on breastfed infants or milk production/excretion