boxed warning
WARNINGS This product is intended for use by physicians who are experienced in the administration of allergenic extract or for use under the guidance of an allergy specialist. In previously untreated patients, the initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from alum-adsorbed or other types of precipitated extracts to this extract should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur. As with all allergenic extracts, severe systemic reactions may occur and in certain individuals these reactions may be lifethreatening or cause death. Patients should be observed for at least 20 minutes following treatment. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life-threatening reaction. Patients being switched to a new lot of extract from the same manufacturer should have the dose reduced 75 percent. For dose selection in switching patients from unstandardized to standardized extract, physicians may refer to Table 3 as a guide (see CLINICAL PHARMACOLOGY). Extracts labeled in BAU/mL are not directly interchangeable with any other grass pollen product. Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine, in the event that epinephrine is required to control an adverse allergic reaction to this product. Caution must be exercised in testing and treating patients with steroid-dependent or labile asthma. This product should never be injected intravenously. See also WARNINGS and ADVERSE REACTIONS below. Serious adverse reactions to this product should be reported to VAERS at 1-800-822-7967 or www.vaers.hhs.gov.