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

Streptococcus pneumoniae Immunization

Pneumococcal vaccine 13-valent (PCV13) is 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

Immunocompromised adults aged ≥19 years: ACIP guidelines recommend use for adults with immunocompromising conditions, cerebrospinal fluid leak, or cochlear implant

Immunocompetent adults aged ≥65 years: Need for vaccination based on shared decision making between patient and clinician (ie, no longer routinely recommended for all adults aged ≥65 yr)

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

Cerebrospinal fluid leak or cochlear implant

  • 1 dose PCV13 followed by 1 dose pneumococcal vaccine polyvalent (PPSV23) at least 8 weeks later
  • At age ≥65 yr, administer another dose PPSV23 at least 5 yr after previous PPSV23
  • Note: Only 1 dose PPSV23 recommended at age ≥65 yr

Immunocompromised adults aged 19 yr or older

  • 1 dose PCV13 followed by 1 dose PPSV23 at least 8 weeks later, THEN another dose PPSV23 at least 5 yr after previous PPSV23
  • At age ≥65 yr, administer 1 dose PPSV23 at least 5 yr after most recent PPSV23
  • Note: Only 1 dose PPSV23 recommended at age ≥65 yr
  • Immunocompromising conditions
    • Congenital or acquired immunodeficiency, including B- and T-lymphocyte deficiency, complement deficiencies, phagocytic disorders, HIV infection
    • Chronic renal failure
    • Nephrotic syndrome
    • Leukemia
    • Lymphoma
    • Hodgkin disease
    • Generalized malignancy
    • Iatrogenic immunosuppression (eg, drug, radiation therapy)
    • Solid organ transplant
    • Multiple myeloma
    • Anatomical or functional asplenia, including sickle cell disease and other hemoglobinopathies

Immunocompetent adults aged 65 yr or older

  • Based on shared clinical decision making
  • If both PCV13 and PPSV23 administered, PCV13 should be administered first
  • PCV13 and PPSV23 should be administered at least 1 year apart
  • Do not administer during the same visit

Dosage Forms & Strengths

suspension for IM injection

  • 0.5mL/syringe

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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            Contraindicated (1)

            • belimumab

              belimumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.

            Serious - Use Alternative (38)

            • adalimumab

              adalimumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • alefacept

              alefacept decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • anakinra

              anakinra decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              antithymocyte globulin equine decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • azathioprine

              azathioprine decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • basiliximab

              basiliximab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • brodalumab

              brodalumab, pneumococcal vaccine 13-valent. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • budesonide

              budesonide decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • canakinumab

              canakinumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • cortisone

              cortisone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • deflazacort

              deflazacort decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • dexamethasone

              dexamethasone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • etanercept

              etanercept decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • everolimus

              everolimus decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • fludrocortisone

              fludrocortisone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • glatiramer

              glatiramer decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • golimumab

              golimumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hydrocortisone

              hydrocortisone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • infliximab

              infliximab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ixekizumab

              ixekizumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.

            • leflunomide

              leflunomide decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • mercaptopurine

              mercaptopurine decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methotrexate

              methotrexate decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methylprednisolone

              methylprednisolone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • muromonab CD3

              muromonab CD3 decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • mycophenolate

              mycophenolate decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ofatumumab SC

              ofatumumab SC decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.

            • prednisolone

              prednisolone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • prednisone

              prednisone decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • rilonacept

              rilonacept decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • secukinumab

              secukinumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

            • siponimod

              siponimod decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

            • sirolimus

              sirolimus decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tacrolimus

              tacrolimus decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • temsirolimus

              temsirolimus decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            Monitor Closely (12)

            • certolizumab pegol

              certolizumab pegol decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Use Caution/Monitor.

            • cyclosporine

              cyclosporine decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .

            • dengue vaccine

              dengue vaccine, pneumococcal vaccine 13-valent. unspecified interaction mechanism. Use Caution/Monitor. Data are not available to establish safety and immunogenicity of coadministration of dengue vaccine with recommended adolescent vaccines.

            • ibrutinib

              ibrutinib decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ifosfamide

              ifosfamide decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • lomustine

              lomustine decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mechlorethamine

              mechlorethamine decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • melphalan

              melphalan decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • onasemnogene abeparvovec

              onasemnogene abeparvovec decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

            • oxaliplatin

              oxaliplatin decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • procarbazine

              procarbazine decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ustekinumab

              ustekinumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Use Caution/Monitor. Inactivated vaccinations administered during ustekinumab treatment may not elicit an immune response sufficient to prevent disease.

            Minor (2)

            • chloroquine

              chloroquine decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Minor/Significance Unknown.

            • ozanimod

              ozanimod decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

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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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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Prevnar 13 (PF) intramuscular
            -
            0.5 mL solution
            Prevnar 13 (PF) intramuscular
            -
            0.5 mL solution

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            pneumococcal 13-val conj vaccine-dip crm (PF) intramuscular

            PNEUMOCOCCAL CONJUGATE VACCINE - INJECTION

            (NEU-mo-KOK-al pee-dee-AT-rik)

            COMMON BRAND NAME(S): Prevnar 13

            USES: This vaccine is used to help protect from infection due to a certain bacteria (Streptococcus pneumoniae). This bacteria can cause ear infection or other more serious infections (such as pneumonia, meningitis). Some brands are approved for use only in children, while others can be used in both children and adults.Vaccines may not fully protect everyone who receives them.

            HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This vaccine is injected into a muscle by a health care professional. It is usually injected into the thigh in infants or into the upper arm in toddlers, children, and adults.The child may receive up to 4 injections. The number of injections that are given depends on the age of the child. Adults only receive 1 injection.If the child is receiving this vaccination before spleen surgery or before receiving cancer chemotherapy or other drugs that decrease the immune system function, it should be given at least 2 weeks before these procedures to be effective. Talk to your health care professional for more information.

            SIDE EFFECTS: Injection site reactions (e.g., pain, redness, swelling, hard lump), muscle/joint aches, or fever may occur. Ask your health care professional about taking a fever/pain reducer (e.g., acetaminophen) to help treat these symptoms. Drowsiness, irritability, loss of appetite, nausea, or diarrhea may also occur. If any of these effects persist or worsen, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Get medical help right away if you have any very serious side effects, including: seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

            PRECAUTIONS: Before receiving this vaccine, tell your health care professional if you are allergic to it; or to other vaccines (e.g., diphtheria, tetanus, Haemophilus influenzae); or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the product packaging), which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before using this vaccine, tell your health care professional your medical history, especially of: vaccination/immunization history, recent illness/fever, immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment).During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits with your health care professional.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).

            OVERDOSE: Not applicable.

            NOTES: It is important to understand the risks and benefits of vaccinations. Discuss this with your health care professional.Talk to your health care professional about the need for other vaccines to prevent possibly severe illness (e.g., flu shots).Make sure all of your health care professionals know you have received this vaccine. Make sure a note is placed in your medical record of having received this vaccine.

            MISSED DOSE: It is important to receive each vaccination as scheduled. Be sure to ask when each dose should be received and make a note of the schedule.

            STORAGE: Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised March 2020. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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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.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.