Source: FDA, National Drug Code (US) Revision Year: 2020
Allergy to any component of TUBERSOL or an anaphylactic or other allergic reaction to a previous test of tuberculin PPD is a contraindication to the use of TUBERSOL. (See DESCRIPTION and HOW SUPPLIED.)
TUBERSOL should not be administered to:
Allergic reactions may occur following the use of TUBERSOL even in persons with no prior history of hypersensitivity to the product components. (11) Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available.
Syncope (fainting) can occur in association with administration of injectable medicines, including TUBERSOL. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Induration at the TUBERSOL injection site is the expected reaction for a positive skin test (See Interpretation of the Test).
The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL.
To report SUSPECTED ADVERSE REACTIONS, contact the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE) or Food and Drug Administration (FDA) MEDWATCH Program at 1-800-332-1088 and www.fda.gov/medwatch.
False positive or false negative tuberculin skin test reactions may occur in some individuals (See Interpretation of the Test).
False positive tuberculin reaction tests occur in individuals who have been infected with other mycobacteria, including vaccination with BCG.
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test.
Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection (See Interpretation of the Test).
Prior to administration of TUBERSOL, the patient’s current health status and medical history should be reviewed. The physician should review the patient’s immunization history for possible sensitivity to components of TUBERSOL.
The healthcare provider should inform the patient of the need to return for the reading of the test. Self-reading of the test has been shown to be inaccurate and unreliable.
The healthcare provider should give the patient a permanent personal record. In addition, it is essential that the health professional record the testing history in the permanent medical record of each patient. This permanent office record should contain the name of the product, date given, dose, manufacturer and lot number, as well as the test result in millimeters of induration (including 0 mm, if appropriate). Reporting results only as negative or positive is not satisfactory.
Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (8)
Reactivity to TUBERSOL may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for >1 month after vaccination (8) (12) (See Interpretation of the Test).
When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option.
Animal reproduction studies have not been conducted with TUBERSOL. It is also not known whether TUBERSOL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TUBERSOL should be given to a pregnant woman only if clearly needed.
It is not known whether TUBERSOL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TUBERSOL is administered to a nursing woman.
There is no contraindication to tuberculin skin testing of infants. Infants <6 months of age who are infected with M. tuberculosis may not react to TUBERSOL (See Interpretation of the Test).
Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
