Aplisol should not be administered to persons who previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site (see CONTRAINDICATIONS).
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as the presence of tuberculous infection or viral infections (measles, mumps, chickenpox, and HIV), live virus vaccination (measles, mumps, rubella, oral polio and yellow fever), overwhelming tuberculosis, other bacterial infections, drugs (corticosteroids and other immunosuppressive agents) and malignancy. 8, 9
Any condition that impairs or attenuates cell mediated immunity potentially can cause a false negative reaction.
Tuberculin skin test results are less reliable in HIV-infected individuals as CD4 counts decline (see CLINICAL PHARMACOLOGY). 3
Avoid injecting tuberculin subcutaneously. If this occurs, no local reaction develops, but a general febrile reaction and/or acute inflammation around old tuberculous lesions may occur in highly sensitive individuals.
The predictive value of the tuberculin skin test depends on the prevalence of infection with M. tuberculosis and the relative prevalence of cross-reactions with nontuberculous mycobacteria. 9, 10
A separate, sterile, single-use disposable syringe and needle should be used for each individual patient to prevent possible transmission of serum hepatitis virus and other infectious agents from one person to another.
Special care should be taken to ensure that the product is injected intradermally and not into a blood vessel.
Before administration of Aplisol, a review of the patient's history with respect to possible immediate-type hypersensitivity to the product, determination of previous use of Aplisol and the presence of any contraindication to the test should be made (see CONTRAINDICATIONS).
As with any biological product, epinephrine should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.
Failure to store and handle Aplisol as recommended may result in a loss of potency and inaccurate test results. 11, 8
Reactivity to the test may be depressed or suppressed for as long as 5-6 weeks in individuals following immunization with certain live viral vaccines, viral infections or discontinuation of corticosteroids or immunosuppressive agents. 8, 9
INFORMATION TO PATIENTS
Patients should be instructed to report adverse events such as vesiculation, ulceration or necrosis which may occur at the test site in highly sensitive individuals. Patients should be informed that pain, pruritus and discomfort may occur at injection site.
Patient should be informed of the need to return to their physician or health care provider for the reading of the test and of the need to keep and maintain a personal immunization record.
In patients who are receiving corticosteroids or immunosuppressive agents, reactivity to the test may be depressed or suppressed. This reduced reactivity may be present for as long as 5-6 weeks after discontinuation of therapy (see PRECAUTIONS -- General). 9
The reactivity to PPD may be temporarily depressed by certain live virus vaccines. Therefore, if a tuberculin test is to be performed, it should be administered either before or simultaneously with the use of oral polio and/or injection of measles, mumps and rubella vaccines in combined form or as separate antigens, or testing should be postponed for 4-6 weeks. 10
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No long term studies have been conducted in animals or in humans to evaluate carcinogenic or mutagenic potential or effects on fertility with Aplisol.
Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Aplisol. It is also not known whether Aplisol can cause fetal harm when administered to a pregnant woman or can affect the reproduction capacity. Aplisol should be given to a pregnant woman only if clearly needed.
However, the risk of unrecognized tuberculosis and the postpartum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculous meningitis. Although there have not been any reported adverse effects upon the fetus recognized as being due to tuberculosis skin testing, the prescribing physician will want to consider if the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, particularly in certain high risk populations.
Tuberculin skin testing is considered valid and safe throughout pregnancy. 3