General Information:

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 allergen extracts, sterile diluent, sterile vials, sterile syringes should be used and aseptic precautions observed when making a dilution and/or administering the allergen extract injection. A sterile tuberculin syringe graduated in 0.1 mL units to measure each dose for the prescribed dilution should be used. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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 allergen 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 from 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. Patients should be told to wait in the office after injections for at least 30 minutes. 

Drug Interaction: Antihistamines and Hydroxyzine can significantly inhibit the immediate skin test reactions as they tend to neutralize or antagonize the action of histamine (14). 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, it was minor. 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 applicable long acting antihistamine manufacturers for additional information. In the event of a serious adverse reaction, patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. 

Carcinogenesis, mutagenesis, impairment of fertility.

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

Pregnancy: Category C. Animal reproduction studies have not been conducted with D. farinae or D. pteronyssinus mite extracts, it is not known whether this extract can incur fetal harm when administered to a pregnant women or can effect reproduction capacity. Standardized D.farinae or D.pteronyssinus Mite extract should be given to pregnant women and nursing mothers 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 Allergenic Extract, Standardized Mites, is administered to a nursing woman. There are no current studies on secretion of the extract components in human milk, or their effect on the nursing infant. 

Pediatric Use: Children have been used extensively as patients in studies with mite extracts. However, it is recommended that children be treated only when indicated (6,7,8). Allergenic extracts have been tested in children over two years of age (9). (See WARNINGS and ADVERSE REACTIONS).