Allergenic Extract, Standardized Mites

Dust mites belonging to the genus Dermatophagoides are indoor allergens found in humid geographic locations worldwide. D. farinae and D. pteronyssinus occur widely with most homes in the United States coinhabited by both species.11

Mechanism of Action

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. Specific mechanisms may vary depending on the nature of the allergic disease, the allergenic specificities of patients and populations, extract formulations, route of administration, dose and duration of treatment.2

Subcutaneous administration of allergenic extracts is known to elicit numerous immunological changes that are both time and dose-dependent. Many of these changes appear to be related to (or a precursor to) improvements in symptoms and other clinical parameters, as noted above. Specific changes found after immunotherapy with dust mite extracts include significant increases in mite-specific IgG4 antibodies12, interleukin-10-positive T cells, and several T-cell receptors, and significant decreases in serum nitric oxide, eosinophil catonic protein, interleukin-4-positive T cells and IgE-mediated basophil histamine release.13

Carcinogenesis, Mutagenesis or Impairment of Fertility

No studies in animals have been performed to evaluate carcinogenecity, mutagenicity or impairment of fertility.

The dust mites D. farinae and D. pteronyssinus are the major source of allergens in house dust14. The efficacy of immunotherapy for Type I hypersensitivity (i.e. allergy) to airborne allergens2, 15, 16 including dust mite has been well established. Specifically, immunotherapy for allergic hypersensitivity to house dust mite allergens has been addressed in a 1995 Cochrane meta-analysis of 20 randomized, controlled trials of immunotherapy17, and two subsequent updated Cochrane meta-analysis published in 199918 and 200319. In addition, efficacy for immunotherapy in rush or cluster protocols, in which the dose escalation is compressed over days or weeks, has also been demonstrated20,21

Instruct the patient to remain in the office for observation for a minumum of 30 minutes after an injection; longer, if deemed necessary for the individual.

Caution patients that reactions may occur more than 30 minutes after skin testing or an injection.

Instruct patient to recognize the following symptoms as adverse reactions and to immediately return to the office or immediately seek other medical attention if any of these symptoms occur following an injection.

• Unusual swelling and/or tenderness at the injection site
• Swelling of face and/or mouth
• Sneezing, coughing or wheezing
• Shortness of breath
• Nausea
• Dizziness or faintness

PRINCIPAL DISPLAY PANEL - 5 mL/10,000 AU/mL Vial Label

FOR SCRATCH TESTING ONLY

ALLERGENIC EXTRACT

NDC# 22840-0034-3
CANADA DIN# 02231321

STANDARDIZED MITE
DERMATOPHAGOIDES
FARINAE

5 mL 10,000 AU/ML

See Package Insert for Dose
and Route of Administration

GREER

Lenoir, NC 28645
US. Lic. 308

41B
Lot: SAMPLE
Item: GB64A02

Rx Only
Pres. 0.4% Phenol. Store at 2-8C.
Contains 50% v/v Glycerin.

Exp. 12/20/13

PRINCIPAL DISPLAY PANEL - 10 mL/10,000 AU/mL Vial Label

STERILE MULTIPLE-DOSE VIAL

ALLERGENIC EXTRACT

NDC# 22840-0036-6
CANADA DIN# 02231324

STANDARDIZED MITE
DERMATOPHAGOIDES
PTERONYSSINUS

10 mL 10,000 AU/ML

See Package Insert for Dose
and Route of Administration

GREER

Lenoir, NC 28645
US. Lic. 308

1D
Lot: SAMPLE
Item: GB70A04

Rx Only
Pres. 0.4% Phenol. Store at 2-8C.
Contains 50% v/v Glycerin.

Exp. 12/20/13

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

FOR SCRATCH TESTING ONLY

ALLERGENIC EXTRACT

NDC# 22840-0037-3
CANADA DIN# 02231325

MIXTURE OF
STANDARDIZED MITE
D. FARINAE 5,000 AU/ML
D. PTERON. 5,000 AU/ML

5 mL

See Package Insert for Dose
and Route of Administration

GREER

Lenoir, NC 28645
US. Lic. 308

42B
Lot: SAMPLE
Item: GBO3A02

Rx Only
Pres. 0.4% Phenol. Store at 2-8C.
Contains 50% v/v Glycerin.

Exp. 12/20/13

PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

STERILE MULTIPLE-DOSE VIAL

ALLERGENIC EXTRACT

NDC# 22840-0040-9

MIXTURE OF
STANDARDIZED MITE
D. FARINAE 15,000 AU/ML
D. PTERON. 15,000 AU/ML

50 mL

See Package Insert for Dose
and Route of Administration

GREER

Lenoir, NC 28645
US. Lic. 308

39B
Lot: SAMPLE
Item: GBO3A11

Rx Only
Pres. 0.4% Phenol. Store at 2-8C.
Contains 50% v/v Glycerin.

Exp. 12/20/13