pneumococcal vaccine 13-valent (Rx)

Brand and Other Names:Prevnar 13
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

suspension for IM injection

  • 0.5mL/syringe
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Streptococcus pneumoniae Immunization

Indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

Although PCV13 is licensed by the FDA for individuals aged ≥50 yr, ACIP recommends routine vaccination with both PCV13 plus PPSV23 for individuals aged ≥65 yr

Also indicated for adults aged 18-49 yr with the specific immunocompromised conditions noted below

<50 years: Not indicated in otherwise healthy adults

≥50 years: 0.5 mL IM as a single dose

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

ACIP Guidelines, Routine Immunization for Immunocompetent Adults

All adults ≥65 years: ACIP recommends routine vaccination with both PCV13 (13-valent pneumococcal conjugate vaccine) and PPSV23 (23-valent pneumococcal polysaccharide vaccine)

MMWR 2015 Sep 4:64(34);944-947

Pneumococcal vaccine-naïve

  • Administer PCV13 first, and then PPSV23 ≥1 yr later

Previous vaccination with PPSV23

  • A dose of PCV13 should be given ≥1 yr after receipt of the most recent PPSV23 dose
  • For those whom an additional dose of PPSV23 is indicated, this subsequent PPSV23 dose should be given 6-12 months after PCV13 and ≥5 yr after the most recent dose of PPSV23

ACIP Guidelines, Immunocompromising Conditions

PCV13 recommended in addition to PPSV23 for adults aged 18-49 yr with immunocompromising conditions (including chronic renal failure and nephrotic syndrome), functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants who have not previously received PCV13 or PPSV23 (MMWR 2012 Oct 12;61[40]:816-819)

Note: minimum interval between PCV13 and PPSV23 is 8 wk for immunocompromised adults

Dosage Forms & Strengths

suspension for IM injection

  • 0.5mL/syringe
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Streptococcus pneumoniae Immunization

Routine vaccination: 4-dose series at ages 2, 4, and 6 months and at age 12-15 months

Aged 6 weeks through 17 years: Indicated for active immunization to prevent invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F

Aged 6 weeks through 5 years: Also indicated for prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F

Dose: 0.5 mL IM

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

Aged 6 weeks through 5 years

  • Routine vaccination: 4-dose series at ages 2, 4, and 6 months and at age 12-15 months
  • May administer 1st dose as early as age 6 weeks
  • Dosing interval between 1st and 2nd doses, and 2nd and 3rd doses is 4-8 weeks
  • Administer 4th dose at approximately age 12-15 months, and at least 2 months after 3rd dose
  • For children aged 14 through 59 months who have received an age-appropriate series of 7-valent PCV (PCV7), administer a single supplemental dose of 13-valent PCV (PCV13)
  • Catch-up vaccination: Administer 1 dose of PCV13 to all healthy children aged 24 through 59 months who are not completely vaccinated for their age

ACIP Guidelines, Aged 2-5 Years With High Risk

Any of the following conditions:

Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure)

Chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy)

Diabetes mellitus

Cerebrospinal fluid leak

Cochlear implant

Sickle cell disease and other hemoglobinopathies

Anatomic or functional asplenia

HIV infection

Chronic renal failure

Nephrotic syndrome

Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; solid organ transplantation; or congenital immunodeficiency

Dosage for high risk 2-5 years olds

  • 1. Administer 1 dose of PCV13 if 3 doses of PCV (7- or 13-valent) were received previously
  • 2. Administer 2 doses of PCV at least 8 weeks apart if fewer than 3 doses of PCV13 were received previously
  • 3. Administer 1 supplemental dose of PCV13 if 4 doses of PCV7 or other age-appropriate complete PCV7 series was received previously
  • 4. The minimum interval between doses of PCV is 8 wk
  • 5. For children with no history of PPSV23 vaccination, administer PPSV23 at least 8 wk after the most recent dose of PCV13

ACIP Guidelines, Aged 6-17 Years With High Risk

Any of the following conditions:

Cerebrospinal fluid leak

Cochlear implant

Sickle cell disease and other hemoglobinopathies

Anatomic or functional asplenia

Congenital or acquired immunodeficiencies

HIV infection

Chronic renal failure

Nephrotic syndrome

Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; generalized malignancy; solid organ transplantation; or multiple myeloma

1. If neither PCV13 nor PPSV23 has been received previously, administer 1 dose of PCV13 now and 1 dose of PPSV23 at least 8 wk later

2. If PCV13 has been received previously but PPSV23 has not, administer 1 dose of PPSV23 at least 8 wk after the most recent dose of PCV13

3. If PPSV23 has been received but PCV13 has not, administer 1 dose of PCV13 at least 8 wk after the most recent dose of PPSV23

Heart, lung, diabetes, liver diseases in 6-17 year olds

  • Any of the following conditions:
  • Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure)
  • Chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy)
  • Diabetes mellitus
  • Alcoholism
  • Chronic liver disease
  • If the patient has not received PPSV23, administer 1 dose of PPSV23
  • If PCV13 has been received previously, then PPSV23 should be administered at least 8 wk after any prior PCV13 dose

Dosing Considerations

Use in preterm infants

  • U.S. vaccine schedule: Immune response have not been studied
  • Non-U.S. vaccine schedule: When preterm infants (<37 wk gestational age, N = 100) were administered 4 doses, the serotype-specific IgG antibody responses after the 3rd and 4th doses were lower compared to responses among term infants (≥37 weeks gestational age, N = 100) for some serotypes; effectiveness cannot be established from this study
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Interactions

Interaction Checker

and pneumococcal vaccine 13-valent

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            Adverse Effects

            >10%

            Fever

            Irritability

            Altered sleep duration (increased or decreased)

            Decreased appetite

            Redness, swelling, and tenderness at injection site

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            Warnings

            Contraindications

            Documented hypersensitivity to any component or diphtheria toxoid

            Cautions

            Apnea observed following IM vaccination in some premature infants

            IM use only, do not administer IV under any circumstances; take special care to prevent injection into or near a blood vessel or nerve

            Does not replace use of 23-valent pneumococcal polysaccharide vaccination in children >24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immunocompromised

            Because of IM injection, caution in coagulation disorders

            Syncope reported with use of injectable vaccines and may result in serious secondary injury from falls, including skull fracture, cerebral hemorrhage; may occur 15 min after vaccination

            Decision to administer or delay vaccination because of current or recent febrile illness depends on severity of symptoms and etiology of disease; consider deferring administration in patients with moderate or severe acute illness; vaccination should not be delayed for patients with mild acute illness

            Use caution in patients with bleeding disorders, including patients with thrombocytopenia or receiving anticoagulant therapy; bleeding hematoma may occur from IM administration; if patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: N/A

            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.

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            Pharmacology

            Mechanism of Action

            Elicits antibodies in response to antigenic stimulation

            Capsular polysaccharide vaccine against 13 strains of pneumococci, conjugated to nontoxic diphtheria protein

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            Administration

            Incompatibilities

            Syringe: Do not mix with over vaccines or products

            IM Preparation

            Shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container

            Do not use if it cannot be resuspended

            Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration

            This product should not be used if particulate matter or discoloration is found

            IM Administration

            Adults: IM into the deltoid muscle

            Pediatrics: IM in anterolateral aspect of thigh for infants, or deltoid muscle of upper arm in toddlers or young children

            Storage

            Store refrigerated at 2-8 degrees C (36-46 degrees F)

            Do not freeze; discard if vaccine has been frozen

            Vial stopper, tip cap, and rubber plunger of prefilled syringe do not contain latex

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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