Prevnar 13 Pneumococcal Vaccine 13-Valent

Pneumococcal vaccine 13-valent is used 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.

Pneumococcal vaccine 13-valent is available under the following different brand names: Prevnar 13.

Dosages of Pneumococcal Vaccine 13-Valent:

Dosage Forms and Strengths

Suspension for Intramuscular (IM) Injection

• 0.5mL/syringe

Dosage Considerations – Should be Given as Follows:

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 or older: ACIP guidelines recommend use for adults with immunocompromising conditions, cerebrospinal fluid leak, or cochlear implant
• Immunocompetent adults aged 65 years or older: Need for vaccination based on shared decision making between patient and clinician (i.e., no longer routinely recommended for all adults aged 65 years or older)
• Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

A 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 years or older, administer another dose PPSV23 at least 5 years after the previous PPSV23
• Note: Only 1 dose of PPSV23 is recommended at age 65 years or older

Immunocompromised adults aged 19 years or older

• 1 dose PCV13 followed by 1 dose PPSV23 at least 8 weeks later, then another dose PPSV23 at least 5 years after previous PPSV23
• At age 65 years or older, administer 1 dose PPSV23 at least 5 years after the most recent PPSV23
• Note: Only 1 dose of PPSV23 is recommended at age 65 years or older
• 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 (e.g., drug, radiation therapy)
  • Solid-organ transplant
  • Multiple myeloma
  • Anatomical or functional asplenia, including sickle cell disease and other hemoglobinopathies

Immunocompetent adults aged 65 years or older

• Based on shared clinical decision making
• If both PCV13 and PPSV23 are administered, PCV13 should be administered first
• PCV13 and PPSV23 should be administered at least 1 year apart
• Do not administer during the same visit
• Routine vaccination: 4-dose series at ages 2, 4, and 6 months and 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 the 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 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 weeks
5. For children with no history of PPSV23 vaccination, administer PPSV23 at least 8 weeks 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 have been received previously, administer 1 dose of PCV13 now and 1 dose of PPSV23 at least 8 weeks later
2. If PCV13 has been received previously but PPSV23 has not, administer 1 dose of PPSV23 at least 8 weeks 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 weeks 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 (under 37 weeks 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 or older, N = 100) for some serotypes; effectiveness cannot be established from this study

Common side effects of pneumococcal vaccine 13-valent include:

• Fever
• Irritability
• Altered sleep duration (increased or decreased)
• Decreased appetite
• Redness, swelling, and tenderness at the injection site

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, 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, health care provider or pharmacist first.

• Severe interactions of pneumococcal vaccine 13-valent include:
  • belimumab
• Pneumococcal vaccine 13-valent has serious interactions with at least 38 different drugs.
• Moderate interactions of pneumococcal vaccine 13-valent include:
  • certolizumab pegol
  • dengue vaccine
  • ibrutinib
  • ifosfamide
  • lomustine
  • mechlorethamine
  • melphalan
  • onasemnogene abeparvovec
  • oxaliplatin
  • procarbazine
  • ustekinumab
• Mild interactions of pneumococcal vaccine 13-valent include:
  • chloroquine

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

If your doctor has directed you to use this medication, 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, health care provider or pharmacist first.

Warnings

• This medication contains pneumococcal vaccine 13-valent. Do not take Prevnar 13 if you are allergic to pneumococcal vaccine 13-valent or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity to any component or diphtheria toxoid

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Pneumococcal Vaccine 13-Valent?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Pneumococcal Vaccine 13-Valent?”

Cautions

• Apnea observed following intramuscular (IM) vaccination in some premature infants
• IM use only, do not administer intravenously (IV) under any circumstances; take special care to prevent injection into or near a blood vessel or nerve
• Does not replace the use of 23-valent pneumococcal polysaccharide vaccination in children over 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 the use of injectable vaccines and may result in serious secondary injury from falls, including a skull fracture, cerebral hemorrhage; may occur 15 minutes after vaccination
• The decision to administer or delay vaccination because of current or recent febrile illness depends on the 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 the patient receives antihemophilic or other similar therapy, IM injection can be scheduled shortly after such therapy is administered

Pregnancy and Lactation

• Use pneumococcal vaccine 13-valent with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• There is no information available regarding the use of pneumococcal vaccine 13-valent in lactating women. Consult your doctor before breastfeeding.