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Vaxneuvance

Vaxneuvance

vaccine, pneumococcal

Manufacturer:

Merck Sharp & Dohme
Concise Prescribing Info
Contents
Pneumococcal 15-valent conjugate vaccine (adsorbed)
Indications/Uses
Active immunization for prevention of invasive disease, pneumonia & acute otitis media caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F & 33F in infants, childn & adolescents from 6 wk to 17 yr. Active immunization for prevention of invasive disease & pneumonia caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F & 33F in adults ≥18 yr.
Dosage/Direction for Use
IM 0.5 mL (1 dose) inj in deltoid muscle of upper arm in adult & childn, or anterolateral aspect of thigh in infants. Adult Single dose. Ped Routine vaccination schedule Infant 6 wk-6 mth 3-dose regimen (2-dose primary series followed by toddler dose) Administer 1st dose as early as 6 wk-2 mth, followed by 2nd dose 2 mth later, then 3rd dose between 11-15 mth. 4-dose regimen (3-dose primary series followed by toddler dose); preterm infant <37 wk gestation at birth Administer 1st dose as early as 6 wk-2 mth w/ at least 4 wk interval between doses in primary series, followed by 4th dose between 11-15 mth & at least 2 mth after 3rd dose. Catch-up vaccination schedule Pneumococcal vaccine-naïve or not fully vaccinated or completed a dosing regimen w/ lower-valency pneumococcal conjugate vaccines Childn & adolescent 2-17 yr Single dose, 12-23 mth 2 doses w/ 2 mth interval between doses, infant 7-11 mth 3 doses. Administer 1st 2 doses at least 4 wk apart, then 3rd dose after 12 mth, separated from 2nd dose by at least 2 mth. Previous pneumococcal conjugate vaccine was administered At least 2 mth should elapse prior treatment.
Contraindications
History of severe allergic reaction (eg, anaphylaxis) to any component of pneumococcal 15-valent conjugate vaccine or diphtheria toxoid-containing vaccine.
Special Precautions
May not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine. Not to be inj intravascularly & in gluteal area or areas where there may be a major nerve trunk &/or blood vessel. Reduced immune response in patients w/ altered immunocompetence including those receiving immunosuppressive therapy. Appropriate medical treatment & supervision should always be readily available in case of rare anaphylactic event following vaccination. Postpone vaccination in individuals suffering from acute severe febrile illness or acute infection. Caution to individuals receiving anticoagulant therapy, or to those w/ thrombocytopenia or any coagulation disorder eg, haemophilia. May not protect all vaccine recipients. Not to be diluted or mixed w/ other vaccines. Administer vaccine at different inj site when given at the same time w/ another inj vaccine. Not to be used vaccine if it cannot be resuspended; if particulate matter or discoloration is found. Pregnancy & lactation. Potential risk of apnea w/ any IM vaccine in premature infant. Childn <6 wk.
Adverse Reactions
Local reactions: Pain, erythema, swelling, induration. Systemic reactions: Decreased appetite, irritability, somnolence, urticaria, fatigue, headache, myalgia, elevated body temp.
Drug Interactions
Reduced immune responses to vaccines w/ immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids, therapeutic proteins & targeted immunomodulators.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.
Presentation/Packing
Form
Vaxneuvance susp for inj 0.5 mL
Packing/Price
1's
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