General: Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations.
Information for Patients: VIOKASE® should not be held in the mouth as the proteolytic action may cause irritation of the mucosa.
Avoid inhalation of the powder when administering VIOKASE®.
Carcinogenesis, Mutagenesis: Long-term studies in animals have not been performed to evaluate the carcinogenic potential.
Pregnancy Category C: Animal reproduction studies have not been conducted with VIOKASE®. It is also not known whether VIOKASE® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VIOKASE® should be given to a pregnant woman only if clearly needed.
Nursing Mothers: 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 pancrelipase is administered to a nursing mother.