"The U.S. Food and Drug Administration today expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibat"...
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For planning cancer chemotherapy or other immunosuppressive therapy (e.g., for patients with Hodgkin's disease or those who undergo organ or bone marrow transplantation), the timing of the vaccination is critical. (See INDICATIONS, Timing of Vaccination.)
If the vaccine is used in persons receiving immunosuppressive therapy, the expected serum antibody response may not be obtained and potential impairment of future immune responses to pneumococcal antigens may occur.36 (See INDICATIONS, Timing of Vaccination.)
Intradermal administration may cause severe local reactions.
Caution and appropriate care should be exercised in administering PNEUMOVAX (pneumococcal vaccine polyvalent) 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Any febrile respiratory illness or other active infection is reason for delaying use of PNEUMOVAX (pneumococcal vaccine polyvalent) 23, except when, in the opinion of the physician, withholding the agent entails even greater risk.
In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended. However, revaccination once is recommended for persons aged ≥ 2 years who are at highest risk for serious pneumococcal infections and those likely to have a rapid decline in pneumococcal antibody levels. (See INDICATIONS, Revaccination.)
Instructions to Health Care Provider
The health care provider should determine the current health status and previous vaccination history of the vaccinee. (See INDICATIONS, Revaccination.)
The health care provider should question the patient, parent or guardian about reactions to a previous dose of PNEUMOVAX 23 or other pneumococcal vaccine.
Pregnancy Category C: Animal reproduction studies have not been conducted with PNEUMOVAX (pneumococcal vaccine polyvalent) 23. It is also not known whether PNEUMOVAX (pneumococcal vaccine polyvalent) 23 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PNEUMOVAX (pneumococcal vaccine polyvalent) 23 should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is administered to a nursing woman.
PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is not indicated in children less than 2 years of age. Safety and effectiveness in children below the age of 2 years have not been established. Children in this age group respond poorly to the capsular types contained in this polysaccharide vaccine. (See CLINICAL PHARMACOLOGY, Immunogenicity.)
Persons 65 years of age or older were enrolled in several clinical studies of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 that were conducted pre- and post-licensure. In the largest of these studies, the safety of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in adults 65 years of age and older was compared to the safety of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in adults 50 to 64 years of age. Of 1007 subjects enrolled in this study, 433 subjects were 65 to 74 years of age, and 195 subjects were 75 years of age or older. No overall difference in safety was observed between these subjects and younger subjects. However, since 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.
36. Siber, G.R.; Gorham, C.; Martin, P.; Corkery, J.C.; Schiffman, G.: Antibody response to pretreatment immunization and post-treatment boosting with bacterial polysaccharide vaccines in patients with Hodgkin's disease, Ann. Intern. Med. 104:467-475, 1986.
37. Vaccine Adverse Event Reporting System - United States, Morbidity and Mortality Weekly Report. 39(41): 730-33, October 19,1990.
Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.
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