General: Epinephrine 1:1000 should be available as well as personnel trained in administering emergency treatment. Allergenic Extracts are not intended for intravenous injections. For safe and effective use of allergenic extracts, sterile diluents, sterile vials, sterile syringes should be used and aseptic precautions observed when making a dilution and/or administering the allergenic extract injection. A sterile tuberculin syringe graduated in 0.1 mL units to measure each dose for the prescribed dilution should be used. 

To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing. Patients should be observed for 30 minutes after any test.

Information for Patients: All concentrates of allergenic extracts including standardized pollen extracts, have the potential to cause serious local and systemic reactions including death, in sensitive patients. To minimize this potential hazard, the relative sensitivity of the patient must be assessed from an allergic history and clinical observations. In certain individuals, life-threatening reactions may occur. Patients should be informed of this risk prior to skin testing and immunotherapy. Patients should be instructed to recognize adverse reaction symptoms that may occur and to report all adverse reactions to a physician and to wait in the office at least 30 minutes after an injection. 

Drug Interactions: Antihistamines and Hydroxyzine can significantly inhibit the immediate skin test reactions as they tend to neutralize or antagonize the action of histamine.(3) This effect has been primarily documented when testing was performed within 1 to 2 hours after drug ingestion, although partial inhibition of the skin test reaction had been observed for longer periods. Epinephrine injection inhibits the immediate skin test reactions for several hours. Patients on delayed absorption antihistamine tablets should be free of such medication for 48 hours before testing. Patients using Astemizole (Hismanal) may experience prolonged suppression and should be free from such medication for up to 6 to 8 weeks prior to testing. Refer to package insert from a long acting antihistamine manufacturer for more information. 

Extreme caution should be taken when using allergenic extracts in patients who are taking beta-blockers. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodialators. 

Carcinogenesis, mutagenesis, impairment of fertility.

Long term studies in animals have not been conducted with allergenic extracts, including Pollen extracts, to determine their potential carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy: Category C. Animal reproduction studies have not been conducted with allergenic extract. It is not known whether this extract can cause fetal harm when administered to a pregnant women or can effect reproduction capacity. Due to histamines ability to induce uterine contractions, allergenic extract should be given to pregnant women only if clearly needed. 

Nursing Mothers: It is not known whether this drug appears in human milk. Because many drugs are detected in human milk, caution should be exercised when Allergenic Extracts are administered to a nursing woman. There are no current studies on extract components in human milk, or their effect on the nursing infant. 

Pediatric Use: Allergenic extracts have been used in children over two years of age.(4)