Dermatophagoides farinae and Dermatophagoides pteronyssinus

Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity. Greer Standardized Mite Extracts are allergenic extracts indicated for: Diagnosis of skin test reactivity to dust mite allergen. Treatment of mite-induced allergic asthma, rhinitis and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity

The complete mechanisms of allergen immunotherapy are not clear and remain the subject of investigation. The allergic reaction is dependent on the presence of allergen-specific immunoglobulin E (IgE) antibodies that are bound to specific receptors on mast cells and basophils. The presence of IgE antibodies sensitizes these cells, and upon interaction with the appropriate allergens, histamine and other mediators are released which produce local or systemic responses in sensitive individuals, and characteristic symptoms of atopic diseases, such as allergic rhinitis and allergic asthma. Changes in serum antibody and T-lymphocyte responses resulting from immunotherapy have been demonstrated, and these changes often correlate closely with clinical (symptom) improvements.

Do not inject intravenously. Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded.

None. None

Boxed warning (anaphylaxis): Do not inject intravenously. Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. This allergenic product is intended for use only by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. The initial dose must be based on skin test. Serious Systemic Reactions All concentrates of Greer Standardized Mite Extracts have the ability during skin testing and immunotherapy to elicit serious systemic reactions including anaphylactic shock and death.

Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death. Based on published studies, 7,8 systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy. Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain).

Beta Adrenergic Drugs Patients receiving beta blocker drugs may not be responsive to beta adrenergic drugs used to treat anaphylaxis 10, and may wish to temporarily postpone treatment day of skin testing. All such decisions should be made in consultation with the physician.

Store dust mite extract at 2 to 8°C (36 to 46°F). Keep dust mite extract at 2 to 8°C (36 to 46°F) during office use.