Prevnar Warnings, Precautions, Pregnancy, Nursing, Abuse - Pneumococcal 7-valent Conjugate

Prevnar Warnings, Precautions, Pregnancy, Nursing, Abuse - Pneumococcal 7-valent Conjugate

WARNINGS

THIS VACCINE WILL NOT PROTECT AGAINST S. PNEUMONIAE DISEASE CAUSED BY SEROTYPES UNRELATED TO THOSE IN THE VACCINE, NOR WILL IT PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE INVASIVE INFECTIONS SUCH AS BACTEREMIA AND MENINGITIS OR NON-INVASIVE INFECTIONS SUCH AS OTITIS MEDIA.

This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer this vaccine to children with coagulation disorders, it should be given with caution. (See DRUG INTERACTIONS.)

Immunization with Prevnar^®does not substitute for routine diphtheria immunization.

Healthcare professionals should prescribe and/or administer this product with caution to patients with a possible history of latex sensitivity since the packaging contains dry natural rubber.

Prevnar^®is for intramuscular use only. Prevnar^®SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. The safety and immunogenicity for other routes of administration (eg, subcutaneous) have not been evaluated.

Fever, and rarely febrile seizure, have been reported in children receiving Prevnar^®. For children at higher risk of seizures than the general population, acetaminophen or other appropriate antipyretics (dosed according to respective prescribing information) may be administered around the time of vaccination, to reduce the possibility of post-vaccination fever.

CARE IS TO BE TAKEN BY THE HEALTHCARE PROFESSIONAL FOR THE SAFE AND EFFECTIVE USE OF THIS PRODUCT.

1. PRIOR TO ADMINISTRATION OF ANY DOSE OF THIS VACCINE, THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTHCARE PROFESSIONAL SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATIONS IN THE CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH THIS VACCINE AND TO ALLOW AN ASSESSMENT OF RISKS AND BENEFITS.

2. BEFORE THE ADMINISTRATION OF ANY BIOLOGICAL, THE HEALTHCARE PROFESSIONAL SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF ALLERGIC OR ANY OTHER ADVERSE REACTIONS. This should include a review of the patient’s history regarding possible sensitivity; the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.

3. Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization.^36,37,38 (See DRUG INTERACTIONS.)

4. The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccine in children 24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised. Data on sequential vaccination with Prevnar^®followed by 23-valent pneumococcal polysaccharide vaccine are limited. In a randomized study, 23 children ³ 2 years of age with sickle cell disease were administered either 2 doses of Prevnar^®followed by a dose of polysaccharide vaccine or a single dose of polysaccharide vaccine alone. In this small study, safety and immune responses with the combined schedule were similar to polysaccharide vaccine alone.³⁹

5. Since this product is a suspension containing an aluminum adjuvant, shake vigorously immediately prior to use to obtain a uniform suspension prior to withdrawing the dose.

6. A separate sterile syringe and needle or a sterile disposable unit should be used for each individual to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.

7. The vaccine is to be administered immediately after being drawn up into a syringe.

8. Special care should be taken to prevent injection into or near a blood vessel or nerve.

9. Healthcare professionals should prescribe and/or administer this product with caution to patients with a possible history of latex sensitivity since the packaging contains dry natural rubber.

INFORMATION FOR PARENTS OR GUARDIANS

Prior to administration of this vaccine, the healthcare professional should inform the parent, guardian, or other responsible adult of the potential benefits and risks to the patient (see ADVERSE REACTIONS and WARNINGS sections), and the importance of completing the immunization series unless contraindicated. Parents or guardians should be instructed to report any suspected adverse reactions to their healthcare professional. The healthcare professional should provide vaccine information statements prior to each vaccination.

Prevnar^®has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.

Animal reproductive studies have not been conducted with this product. It is not known whether Prevnar^®can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. This vaccine is not recommended for use in pregnant women.

It is not known whether vaccine antigens or antibodies are excreted in human milk. This vaccine is not recommended for use in a nursing mother.

Prevnar^®has been shown to be usually well-tolerated and immunogenic in infants. The safety and effectiveness of Prevnar^®in children below the age of 6 weeks or on or after the 10th birthday have not been established. Immune responses elicited by Prevnar^®among infants born prematurely have not been studied. See DOSAGE AND ADMINISTRATION for the recommended pediatric dosage.

This vaccine is NOT recommended for use in adult populations. It is not to be used as a substitute for the pneumococcal polysaccharide vaccine in geriatric populations.