Safety information
Safety information
PNEUMOVAX® 23 (pneumococcal polysaccharide vaccine)
Prescribing Information [External link]
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed:
- Phenol
- Sodium chloride
- Water for injections
Special warnings and precautions for use
Delay the use of the vaccine in any significant febrile illness, other active infection or when a systemic reaction would pose a significant risk except when this delay may involve even greater risk.
PNEUMOVAX® 23 should never be injected intravascularly, and precautions should be taken to make sure the needle does not enter a blood vessel. Also, the vaccine should not be injected intradermally, as injection by that route is associated with increased local reactions.
If the vaccine is administered to patients who are immunosuppressed due to either an underlying condition or medical treatment (e.g., immunosuppressive therapy such as cancer chemotherapy or radiation therapy), the expected serum antibody response may not be obtained after a first or second dose. Accordingly, such patients may not be as well protected against pneumococcal disease as immunocompetent individuals.
As with any vaccine, vaccination with pneumococcal polysaccharide vaccine may not result in complete protection in all recipients.
For patients receiving immunosuppressive therapy, the time to recovery of the immune response varies with the illness and the therapy. Significant improvement in antibody response has been observed for some patients during the two years following the completion of chemotherapy or other immunosuppressive therapy (with or without radiation), particularly as the interval between the end of treatment and pneumococcal vaccination increased.
As with any vaccine, adequate treatment provisions including epinephrine (adrenaline) should be available for immediate use should an acute anaphylactic reaction occur.
Required prophylactic antibiotic therapy against pneumococcal infection should not be stopped after pneumococcal vaccination.
Patients at especially increased risk of serious pneumococcal infection (e.g., asplenics and those who have received immunosuppressive therapy for any reason), should be advised regarding the possible need for early antimicrobial treatment in the event of severe, sudden febrile illness.
Pneumococcal vaccine may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid.
A clinical study of primary vaccination and revaccination was conducted in 629 adults ≥65 years of age and 379 adults 50 to 64 years of age. The data obtained suggested that the rates of injection site and systemic adverse reactions among subjects ≥65 years of age were not higher than the rates amongst subjects 50 to 64 years of age. It should be noted that, in general, elderly individuals may not tolerate medical interventions as well as younger individuals; a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.
Interaction with other medicinal products and other forms of interaction
PNEUMOVAX® 23 can be administered simultaneously with influenza vaccine as long as different needles and injection site are used.
Pregnancy and lactation
Pregnancy
The vaccine should not be used during pregnancy unless clearly necessary (the potential benefit must justify any potential risk to the foetus).
Breastfeeding
It is unknown whether this vaccine is excreted in human milk. Caution should be exercised when it is administered to a nursing mother.
Adverse events
A full list of side effects can be found in the Summary of Product Characteristics and Patient Information Leaflet [External links].
Side effects of PPV
Very common (≥1/10)
General disorders and administration site conditions:
- Fever (≤38.8 °C)
Injection site:
- Erythema
- Induration
- Pain
- Soreness
- Swelling
- Warmth
Other reported side effects that may potentially be serious
Thrombocytopenia in patients with stabilised idiopathic thrombocytopenic purpura, haemolytic anaemia in patients who have had other haematologic disorders, leukocytosis, lymphadenitis, lymphadenopathy, anaphylactoid reactions, serum sickness, angioneurotic oedema, Guillain-Barré Syndrome, radiculoneuropathy, febrile convulsions, extensive swelling of the vaccinated limb
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Merck Sharp & Dohme (UK) Limited (Tel: 0208 154 8000).
Supporting documentation
- Pneumovax-23 Summary of Product Characteristics.
PNEUMOVAX® 23 (pneumococcal polysaccharide vaccine)
Prescribing Information
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