Pneumococcal Polysaccharide Vaccine (23-Valent)

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Headache.
• Feeling tired or weak.
• Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequency not defined.

Cardiovascular: Peripheral edema (in injected extremity)

Central nervous system: Chills, Guillain-Barre syndrome, febrile seizures, headache, malaise, pain, paresthesia, radiculopathy

Dermatologic: Cellulitis, skin rash, urticaria

Gastrointestinal: Nausea, vomiting

Hematologic & oncologic: C-reactive protein increased, hemolytic anemia (in patients with other hematologic disorders), leukocytosis, lymphadenitis, lymphadenopathy, thrombocytopenia (in patients with stabilized immune thrombocytopenia [formerly known as idiopathic thrombocytopenic purpura])

Hypersensitivity: Anaphylactoid reaction, angioedema, serum sickness

Local: Injection site reaction (most common in clinical trials; includes erythema at injection site, induration at injection site, local soreness/soreness at injection site, swelling at injection site, warm sensation at injection site)

Neuromuscular & skeletal: Arthralgia, arthritis, decreased range of motion (limb), myalgia, weakness

Miscellaneous: Fever (most common in clinical trials: ≤102°F; fever >102°F)

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

• Cardiovascular disease: Use with caution in patients with severely compromised cardiovascular function where a systemic reaction may pose a significant risk.

• HIV: Patients with HIV should be vaccinated as soon as possible following confirmation of the diagnosis (CDC/ACIP, 61[40] 2012).

• Cerebrospinal fluid (CSF) leaks: Vaccination may not be as effective in patients with chronic CSF leaks due to congenital lesions, skull fractures, or neurosurgical procedures.

• Pneumococcal meningitis: Pneumococcal vaccine may not be effective in preventing pneumococcal meningitis in persons who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

• Respiratory disease: Use with caution in patients with severe pulmonary disease where a systemic reaction may pose a significant risk.

• Splenectomy: Patients who will undergo splenectomy should also be vaccinated at least 2 weeks prior to surgery, if possible (IDSA [Rubin 2014]).

• Thrombocytopenia purpura: May cause relapse in patients with stable idiopathic thrombocytopenia purpura.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (NCIRD/ACIP 2011). If a person has not received any pneumococcal vaccine or if pneumococcal vaccination status is unknown, PPSV23 should be administered as indicated.

• Antibiotic prophylaxis: This vaccine does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection. In persons who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with pneumococcal vaccine.

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients; patients who will be receiving immunosuppressive therapy (including Hodgkin disease, cancer chemotherapy, or transplantation) should be vaccinated at least 2 weeks prior to the initiation of therapy. Immune responses may be impaired for several months following intensive immunosuppressive therapy (up to 2 years in Hodgkin disease patients). In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Children: Pneumococcal vaccine is not approved for use in children <2 years. Children in this age group do not develop an effective immune response to the capsular types contained in this polysaccharide vaccine.

• Cochlear implants: Patients who will undergo cochlear implant placement should be vaccinated at least 2 weeks prior to surgery, if possible (IDSA [Rubin 2014]).

• Elderly: Postmarketing reports of adverse effects in elderly patients, especially those with comorbidities, have been significant enough to require hospitalization.

Other warnings/precautions:

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014). Vaccination does not replace the need for antibiotic prophylaxis against pneumococcal infection when otherwise required.

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).

Applies to pneumococcal 23-polyvalent vaccine: injection injectable

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Headache.
• Feeling tired or weak.
• Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

0.5 mL, IM or subcutaneously, once

Comments:
-For use in patients 50 years or older, or in younger patients at increased risk of pneumococcal disease

Administration advice:
-For IM or subcutaneous administration only.
-Administer in the deltoid or lateral mid-thigh.
-Do not inject intravenously or intradermally.

Storage requirements:
-Refrigerate

IV compatibility:
-Do not mix with other vaccines in the same syringe or vial.

Safety has not been established during pregnancy; use only if clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C

Animal studies have not been performed. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used only if clearly needed. Excreted into human milk: Unknown Excreted into animal milk: Data not available