Dosing & Uses
Dosage Forms & Strengths
injection, suspension
- 0.5mL prefilled syringe
- Conjugated to carrier protein (diphtheria CRM197 protein)
Streptococcus pneumoniae Immunization
Indicated for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae
0.5 mL IM once
ACIP pneumococcal vaccine recommendations
-
Pneumococcal vaccine-naïve or vaccination status unknown
- ≥65 years: 0.5 mL IM once; follow with dose of 23-valent PPSV ≥1 yr later
- 19-64 years with certain underlying medical conditions: 0.5 mL IM once (follow with PPSV23 >1 yr later); then, repeat regimen when aged ≥65 years
- PPSV23 previously received: May receive PCV15 ≥1 years after their last PPSV23 dose at discretion of physician
- PCV13 previously received: Public health benefits of providing PCV15 to adults who have received PCV13 only or both PCV13 and PPSV23 have not been evaluated; these adults should complete the previously recommended PPSV23 series
- For more information, see full ACIP recommendations at MMWR January 28, 2022
Dosage Modifications
Renal or hepatic impairment
- Studies not conducted
Dosing Considerations
Vaccine serotypes include 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F
Contains all serotypes in Prevnar 13 plus 2 additional serotypes (22F and 33F)
Specific medical conditions for aged 19-64 years
- Alcoholism
- Chronic heart, liver, or lung disease
- Cigarette smoking
- Diabetes mellitus
- Cochlear implant
- CSF leak
- Congenital or acquired asplenia
- Sickle cell disease or other hemoglobinopathies
- Chronic renal failure
- Congenital or acquired immunodeficiencies
- Generalized malignancy
- HIV infection
- Hodgkin disease, leukemia, lymphoma, multiple myeloma
- Iatrogenic immunosuppression
- Nephrotic syndrome
- Solid organ transplant
Dosage Forms & Strengths
injection, suspension
- 0.5mL prefilled syringe
- Conjugated to carrier protein (diphtheria CRM197 protein)
Streptococcus pneumoniae Immunization
Indicated for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in children aged ≥6 weeks
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
-
Aged at first dose
- 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 give 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 receipt of the last dose of another pneumococcal conjugate vaccine and administration of pneumococcal vaccine 15-valent
Dosage Modifications
Renal or hepatic impairment
Studies not conducted
Dosing Considerations
Vaccine serotypes include 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F
Contains all serotypes in Prevnar 13 plus 2 additional serotypes (22F and 33F)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- elivaldogene autotemcel
elivaldogene autotemcel, pneumococcal vaccine 15-valent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- teplizumab
teplizumab decreases effects of pneumococcal vaccine 15-valent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.
Monitor Closely (4)
- satralizumab
satralizumab decreases effects of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .
- tralokinumab
tralokinumab will decrease the level or effect of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.
- ublituximab
ublituximab decreases effects of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
- voclosporin
voclosporin decreases effects of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.
Minor (0)
Adverse Effects
>10%
Adults
-
All grades
- Pain (55.1-75.8%)
- Fatigue (18.1-34.3%)
- Myalgia (15.7-28.8%)
- Headache (13.4-26.5%)
- Swelling (14.2-21.7%)
- Erythema (7.9-15.1%)
- Arthralgia (5.5-12.7%)
Pediatrics
- Moderate irritability (25-31.4%)
- Mild irritability (23.6-30.2%)
- Mild somnolence (13.9-24.2%)
- Mild pain (16.9-24.1%)
- Moderate somnolence (10-21.6%)
- Fever ≥38ºC (13.3-20.4%)
- Fever >38 to <39ºC (12.1-18.5%)
- Erythema ≤2.5 cm (11-15.4%)
- Moderate pain (8.8-14.7%)
- Decreased appetite, mild (7.5-12%)
- Induration ≤2.5 cm (7.5-11%)
1-10%
Adults
Fever 38ºC to <38.5ºC (0.6-1.6%)
-
Grade 3
- Fatigue (1%)
- Pain (1%)
Pediatrics
- Swelling ≤2.5 cm (5.8-9.5%)
- Decreased appetite, moderate (5.7-7.9%)
- Erythema 2.5-7.6 cm (2.3-6.8%)
- Induration 2.5-7.6 cm (2.8-6.2%)
- Severe irritable (2.6-4.7%)
- Induration 2.5-7.6 cm (2.8-6.2%)
- Swelling 2.5-7.6 cm (3.2-5.5%)
- Fever ≥39 to <40ºC (0.7-2.4%)
- Severe somnolence (0.4-1.7%)
- Mild urticaria (0.8-1.7%)
- Moderate urticaria (0.2-1.5%)
- Severe pain (0.2-1.5%)
<1%
Adults
Fever 38.5ºC to <39ºC (0.1-0.3%)
Fever ≥39ºC (0.2%)
-
Grade 3
- Pain (0.8-0.9%)
- Erythema, >10 cm (0.5-0.8%)
- Headache (0.4-0.8%)
- Myalgia (0.3-0.8%)
- Fatigue (0.7%)
- Arthralgia (0.2-0.4%)
- Swelling, >10 cm (0.2-0.4%)
Pediatrics
- Decreased appetite, severe (0.4-0.5%)
- Fever ≥40ºC (0.1-0.5%)
- Erythema >7.6 cm (0.2-0.3%)
- Severe urticaria (0.2%)
- Induration >7.6 cm (0.2%)
- Swelling >7.6 cm (0.2%)
Warnings
Contraindications
Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or to diphtheria toxoid
Cautions
Administer in 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 premature infants based on infant’s medical status and potential benefits and possible risks
Drug interaction overview
- Immunosuppressive therapies may reduce immune response to vaccine
Pregnancy & Lactation
Pregnancy
No adequate and well-controlled studies have been conducted in pregnant women; data are insufficient to inform vaccine-associated risks in pregnancy
Animal studies
- Developmental toxicity studies in female rats administered a human dose have been conducted on 4 occasions (twice before mating, once during gestation, and once during lactation)
- These studies revealed no evidence of harm to the fetus
Lactation
Data are not available to assess vaccine impact on milk production, its presence in breast milk, or its effects on breastfed children
Consider 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 from underlying maternal condition; for preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Protection against invasive disease conferred mainly by opsonophagocytic killing of S pneumoniae
Vaccine induces opsonophagocytic activity against the serotypes contained in vaccine
Administration
IM Preparation
Hold syringe horizontally and shake vigorously immediately before administration to obtain an opalescent suspension
Discard if it cannot be resuspended
Inspect visually for particulate matter and discoloration; do not use if particulate matter or discoloration observed
IM Administration
For IM administration only
Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration
Storage
Refrigerate at 2-8ºC (36-46ºF)
Do not freeze
Protect from light
Preservative-free suspension
Tip cap and plunger stopper of prefilled syringe are not made with natural rubber latex
Images
Formulary
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