Pneumococcal Vaccine 15-valent

Pneumococcal Vaccine15-valent is used for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae.

• Pneumococcal Vaccine 15-valent is available under the following different brand names: Vaxneuvance

Common side effects of Pneumococcal Vaccine 15-valent include:

• injection site reactions (pain, redness, swelling)
• fatigue
• muscle pain
• headache
• joint pain

Serious side effects of Pneumococcal Vaccine 15-valent include:

• NA

Rare side effects of Pneumococcal Vaccine 15-valent 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, light-headedness, 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

Injection, suspension

• 0.5 mL prefilled syringe
• Conjugated to a carrier protein (diphtheria CRM197 protein)

Streptococcus pneumoniae immunization

Adult dosage

• 0.5 mL IM once
• ACIP pneumococcal vaccine recommendations
• Pneumococcal vaccine-naïve or vaccination status unknown
• Aged 65 years or above: 0.5 mL IM once; follow with a dose of 23-valent PPSV 1 yr or more or later
• 19-64 years with certain underlying medical conditions: 0.5 mL IM once (follow with PPSV23 more than 1 year later); then, repeat the regimen when aged 65 years or above

Pediatric dosage

• 4-dose series: 0.5 mL IM at 2, 4, 6, and 12-15 months of age
• First dose may be given as early as 6 weeks old
• 4-dose series initiated with lower valency pneumococcal conjugate vaccine can be completed with Pneumococcal Vaccine 15-valent
• Catch-up schedule for children who have never received a pneumococcal vaccine
• 7-11 months: 3 doses; first 2 doses given at least 4 weeks apart; third dose given after one-year birthday, separated from the second dose by at least 2 months
• 12-23 months: 2 doses given at least 2 months apart
• 2-17 years: 1 dose
• Catch-up schedule for children previously vaccinated with a pneumococcal vaccine
• Administer single dose to children and adolescents aged 2-17 years who have received an incomplete series of another pneumococcal vaccine
• At least 2 months should elapse between the receipt of the last dose of another pneumococcal conjugate vaccine and administration of pneumococcal Vaccine 15-valent

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.

• Pneumococcal Vaccine 15-valent has severe interactions with no other drugs.
• Pneumococcal Vaccine 15-valent has serious interactions with the following drugs:
  • elivaldogene autotemcel
  • teplizumab
• Pneumococcal Vaccine 15-valent has moderate interactions with the following drugs:
  • satralizumab
  • tralokinumab
  • ublituximab
  • voclosporin
• Pneumococcal Vaccine 15-valent has minor interactions with no 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

• Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or diphtheria toxoid

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pneumococcal Vaccine 15-valent?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pneumococcal Vaccine 15-valent?”

Cautions

• Administer in a facility with appropriate medical treatment to manage allergic reactions
• Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have reduced immune response
• Apnea following IM observed in some infants born prematurely; consider when to administer Pneumococcal vaccine 15-vaccine to premature infants based on the infant’s medical status and potential benefits and possible risks
• Drug interaction overview
  • Immunosuppressive therapies may reduce the immune response to the vaccine

Pregnancy and Lactation

• No adequate and well-controlled studies have been conducted on pregnant women; data are insufficient to inform vaccine-associated risks in pregnancy
• Lactation
  • Data are not available to assess the vaccine’s impact on milk production, its presence in breast milk, or its effects on breastfed children
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy, and any potential adverse effects on breastfed children from the drug or any underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine