Pneumococcal 13-valent conjugate vaccine

What is Pneumococcal 13-valent conjugate vaccine?

Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 protein.

What are the uses of this medicine?

Children 6 Weeks Through 5 Years of Age In children 6 weeks through 5 years of age (prior to the 6th birthday), Prevnar 13® is indicated for:

• active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
• active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.

Children 6 Years Through 17 Years of Age In children 6 years through 17 years of age (prior to the 18th birthday), Prevnar 13 is indicated for:

• active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Adults 18 Years of Age and Older In adults 18 years of age and older, Prevnar 13 is indicated for:

• active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Limitations of Prevnar 13 Use and Effectiveness

• Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.

How does this medicine work?

• A pneumococcal conjugate vaccine containing 13 different strains of the bacterium streptococcus pneumoniae, used in children and studied in immunocompromised patients for the prevention of pneumococcal disease.
• The pneumococcal 13-valent conjugate vaccine contains capsular antigen polysaccharides derived from the s. Pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f that are individually conjugated to a nontoxic diphtheria cross-reactive material (crm) carrier protein (crm197).
• Upon vaccination, pneumococcal 13-valent conjugate vaccine induces active immunization against 13 different serotypes of s. Pneumoniae and protects against pneumococcal disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine

What drug interactions can this medicine cause?

• When Prevnar 13 is administered at the same time as another injectable vaccine(s), the vaccines should always be administered with different syringes and given at different injection sites.
• Do not mix Prevnar 13 with other vaccines/products in the same syringe.
• Individuals with impaired immune responsiveness due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may not respond optimally to active immunization.
• Prior receipt of PPSV23 within 1 year results in diminished immune responses to Prevnar 13 compared to PPSV23 naïve individuals

Is this medicine FDA approved?

• Initial U.S. Approval: 2010

How should this medicine be used?

Recommended Dosage:

• Children 6 weeks through 5 years: The four-dose immunization series consists of a 0.5 mL intramuscular injection administered at 2, 4, 6, and 12–15 months of age.
• Children 6 through 17 years of age: a single dose.
• Adults 18 years and older: a single dose.

Administration

• Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container.
• Do not use the vaccine 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.
• Do not mix Prevnar 13 with other vaccines/products in the same syringe.
• For intramuscular injection only.
• Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe.
• The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, children and adults.
• The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.5 mL suspension for intramuscular injection, supplied in a single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• Prevnar 13

What side effects can this medication cause?

The most common side effects of this medicine include: In infants and toddlers vaccinated at 2, 4, 6, and 12–15 months of age:

• irritability
• injection site tenderness
• decreased appetite
• decreased sleep
• increased sleep
• injection site redness
• injection site swelling

In children aged 5 through 17 years:

• injection site tenderness
• injection site redness
• injection site swelling
• irritability
• decreased appetite
• ncreased sleep
• fever
• decreased sleep

In adults aged 18 years and older:

• pain at the injection site
• fatigue
• headache
• muscle pain
• joint pain
• decreased appetite
• injection site redness
• injection site swelling
• limitation of arm movement
• vomiting
• fever
• chills
• rash

What special precautions should I follow?

• Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, to infants born prematurely should be based on consideration of the individual infant's medical status, and the potential benefits and possible risks of vaccination.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data on Prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
• STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Inactive ingredients:

• CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN
• POLYSORBATE 80
• ALUMINUM PHOSPHATE
• SUCCINATE DIANION

Who manufactures and distributes this medicine?

• Packager: Wyeth Pharmaceutical Division of Wyeth Holdings LLC

What should I know about storage and disposal of this medication?

• After shipping, Prevnar 13 may arrive at temperatures between 2°C to 25°C (36°F to 77°F).
• Upon receipt, store refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze. Discard if the vaccine has been frozen.
• Prevnar 13 is stable at temperatures up to 25°C (77°F) for 4 days. These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions.
• The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

• Dailymed label info on Pneumococcal 13-valent conjugate vaccine
• FDA Pneumococcal 13-valent conjugate vaccine

Pneumococcal 13-valent conjugate vaccine Resources
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