Abbreviated prescribing information

Prevenar 13®▼suspension for injection
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Presentation

Each 0.5ml dose of Prevenar 13 contains 2.2 micrograms of each of the following polysaccharide serotypes: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 micrograms of polysaccharide serotype 6B.  Each polysaccharide is conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium).

Indications:

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

Dosage and administration

For intramuscular injection. 
It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.
Infants aged 6 weeks-6 months:
Three-dose primary series:  The recommended immunisation series consists of four doses. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.
Two-dose primary series: Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended between 11 and 15 months of age.
Unvaccinated infants and children ≥ 7 months of age:
Infants aged 7 11 months: Two doses, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.
Children aged 12 23 months: Two doses, with an interval of at least 2 months between doses.
Children aged 2 5 years: One single dose.
Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F)
Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule.
Children aged 12-23 months: Children who have not received two doses of Prevenar 13 during the infant series should receive two doses of the vaccine (with an interval of at least 2 months between doses) to complete the immunisation series for the six additional serotypes. Alternatively, complete the immunisation series according to official recommendations.
Children aged 2-5 years: One single dose.

Adults aged 50 years and older: One single dose.
The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
Regardless of prior pneumococcal vaccination status, if the use of 23 valent polysaccharide vaccine  is considered appropriate, Prevenar 13 should be given first.

Contra-indications

Hypersensitivity to the active substances, to any of the excipients, or to diphtheria toxoid. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

Warnings and precautions

Do not administer intravascularly.  Appropriate medical treatment and supervision must be available in case of anaphylaxis. It should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks.  Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization. Safety and immunogenicity data for Prevenar 13 are not available for individuals in specific immuno-compromised groups (e.g., congenital or acquired splenic dysfunction, HIV infected, malignancy, haematopoietic stem cell transplant, nephrotic syndrome) and vaccination should be considered on an individual basis.

Infants and children aged 6 weeks to 5 years
Limited data have demonstrated that Prevenar 7 valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non high-risk groups. Children younger than 2 years old should receive the appropriate-for-age Prevenar 13 vaccination series.  The use of pneumococcal conjugate vaccine does not replace 23-valent polysaccharide vaccine in at risk children ≥ 2 years of age. Children ≥ 2 years of age at high risk, previously immunised with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine whenever recommended.  The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.  Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or a prior history of febrile seizures, or when vaccinating simultaneously with whole cell pertussis vaccines. 

Fertility, Pregnancy & Lactation:
There are no data from the use of pneumococcal 13-valent conjugate in pregnant women. It is unknown whether pneumococcal 13-valent conjugate is excreted in human milk.

Side Effects:
Adverse reactions reported in clinical studies or from the post-marketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: very common (≥ 1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥  1/10,000 to < 1/1,000), very rare (≤ 1/10,000), not known (cannot be estimated from available data).

Infants and children aged 6 weeks to 5 years
Very common (≥ 1/10): Decreased appetite, fever, pyrexia, irritability, any injection-site reactions (including erythema, induration/swelling [2.5 cm – 7.0 cm after booster dose and in older children, aged 2 to 5 years] or pain/tenderness), drowsiness, restless sleep.  Common (≥ 1/100 to < 1/10): Fever over 39 °C, injection-site movement impairment (due to pain), injection-site erythema or induration/swelling 2.5 cm – 7.0 cm (after infant series).  Uncommon (≥ 1/1,000 to < 1/100): Vomiting, diarrhoea, injection-site erythema, induration/swelling > 7.00 cm, crying.  Rare (≥ 1/10,000 to < 1/1,000): Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, convulsions (including febrile convulsions), hypotonic-hyporesponsive episode, rash, urticaria or urticaria-like rash, anaphylactic/anaphylactoid reaction including shock, angioedema, injection-site urticaria, injection-site dermatitis, injection-site pruritis, flushing.  Very rare (≤ 1/10,000): Lymphadenopathy (localised to the region of the injection site), erythema multiforme
Additional information in special populations: Apnoea in very premature infants (≤28 weeks of gestation).

Adults aged 50 years and older
Very common (≥ 1/10): Decreased appetite, headaches, diarrhoea, rash, chills; fatigue; injection-site erythema; injection-site induration/swelling; injection-site pain/tenderness; limitation of arm movement, arthralgia; myalgia Common (≥ 1/100 to < 1/10): Vomiting, pyrexia,Uncommon (≥ 1/1,000 to < 1/100):     Nausea, hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, lymphadenopathy localized to the region of the injection site. Legal Category: POM 

Package Quantities:  Pack of 1 single-dose pre-filled syringe (with separate needle) or pack of 10 single-dose pre-filled syringes

Cost:
There is no cost to immunisers supplied under the UK routine childhood immunisation programme.  Cost for supply outside the UK routine childhood immunisation programme:  Single-dose pre-filled syringe (with separate needle) pack of 1:  £49.10;   single-dose pre-filled syringe pack of 10:  £491.

Marketing Authorisation Numbers:
Single-dose pre-filled syringe (with separate needle) pack of 1: EU/1/09/590/002, single-dose pre-filled syringe pack of 10: EU/1/09/590/003
Marketing Authorisation Holder: Wyeth-Lederle Vaccines S.A., Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel – Bruxelles, Belgium
For full prescribing information and details of other side effects see Summary of Product Characteristics
Further information is available on request from Medical Information Department at Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK.
Date of Prescribing Information: October 2011

Ref: PN 2_1

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk. Adverse events should also be reported to Pfizer Medical Information on 01304 616161

Further information on adverse event reporting can be found by clicking here.

Summary of Product Characteristics can be found on electronic Medicines Compendium (eMC) click here to view.

Patient information Leaflet can be found on electronic Medicines Compendium (eMC) click here to view and download.