Dermatophagoides Farinae
FDA Drug Information • Also known as: Standardized Mite Dermatophagoides Farinae
- Brand Names
- Standardized Mite Dermatophagoides Farinae
- Drug Class
- Standardized Insect Allergenic Extract [EPC]
- Route
- INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
- Dosage Form
- CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
WARNING: ANAPHYLAXIS Do not inject intravenously. (2.2) Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. (5.1) 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. (5.1) The initial dose must be based on skin test. (2.1) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction. (5.1) Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction, including significant cardiovascular and/or pulmonary diseases. Patients who are receiving beta blockers may be unresponsive to the usual doses of epinephrine used to treat systemic reactions, including anaphylaxis. (5.2) WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Do not inject intravenously (2.2) Allergenic extracts may cause severe life-threatening systemic reactions, including the rare occurrence of anaphylaxis or death (5.1) Intended for use only by experts experienced in administering allergic extracts and trained to provide emergency treatment (5.1) Initial dose must be based on skin test (2.1) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction (5.1) Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction (5)
Description
11 DESCRIPTION Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus ), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.
What Is Dermatophagoides Farinae Used For?
1 INDICATIONS AND USAGE 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 (1) 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 (1)
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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. 2.1 Diagnostic Testing For diagnosis of a patient with a suspected allergy to either species of dust mite ( D. farinae or D. pteronyssinus ), diagnostic skin testing should include the standardized mite mixture or the single-species mite extracts. If a skin test with the standardized mite mixture elicits a positive reaction, then the single-species mite extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated. A positive skin test reaction to any allergen must be interpreted in light of the patient's history of symptoms, the time of year, and known exposure to environmental allergens. 2.1.1 Percutaneous Skin Testing For percutaneous (scratch, prick, or puncture) testing, use 10,000 Allergy Units/mL Greer Standardized Mite Extract stock concentrate in dropper vials. If patient is suspected of having exquisite sensitivity, such as anaphylaxis, to certain foods and drugs, initiate percutaneous testing with several serial 10-fold dilutions of the usual test concentration. For scratch tests, scarify the skin, and then apply one drop of the extract to the scratch. For prick tests, place one drop of extract on the skin and pierce through the drop into the skin with a slight lifting motion. For puncture tests, place one drop of extract on the skin and pierce through the drop perpendicular to the skin. When using percutaneous test devices, follow the directions provided with the test devices. Include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 10 mg/mL (6 mg/mL histamine base) may be used as the positive control. Include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 50% glycerosaline solution may be used as the negative control. Read skin tests 15-20 minutes after exposure. Record the induration (wheal) and erythema (flare) response by noting the longest diameter of each, or by the sum of the longest erythema diameter and the mid-point orthogonal diameters of erythema (ΣE). Percutaneous testing devices often have their own grading systems, as these...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS 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). Although most adverse systemic reactions occur within 30 minutes of injection (some within minutes of extract exposure), such reactions also can occur up to six hours after skin tests or immunotherapy [see Dosage and Administration (2.2)]. 9 Systemic reactions may be fatal or near fatal (6) Systemic reactions (e.g. generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension) occur in 4-7% of patients The most common reactions are local reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain), occuring in 26% to 82% of patients (6) To report SUSPECTED ADVERSE REACTIONS, contact Greer Laboratories, Inc., at 1-855-274-1322 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Drug Interactions
7 DRUG INTERACTIONS 7.1 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 [see Warnings and Precautions (5.2)]. 7.2 Antihistamines 1 Skin testing with allergenic extracts should not be performed within 2-3 days of first-generation H 1 -histamine receptor blockers (e.g., clemastine, diphenhydramine) and within 3 to 10 days of second-generation antihistamines (e.g., loratadine, terfenadine), except for astemizole, which requires an interval of 30-60 days between allergenic extract exposure and use. These products suppress histamine skin test reactions and could mask a positive response. 7.3 Topical Corticosteroids and Topical Anesthetics 1 Topical corticosteroids may suppress skin reactivity and should be discontinued at the skin test site for at least 2-3 weeks before skin testing. Topical local anesthetics may suppress flare responses and should be avoided at skin test sites. 7.4 Tricyclic Antidepressants 1 Tricyclic antidepressants can have potent antihistamine effects and will affect skin testing. Since use of tricyclics may alter skin test results, dosing for both skin testing and immunotherapy should be done with caution. If tricyclic medication has been recently discontinued, allow 7-14 days prior to skin testing to obviate the antihistamine effect. The risk of anaphylaxis in these patients should be carefully weighed against the risks and benefits of stopping tricyclics. 7.5 Other Drugs The suppressive action of other drugs should be considered and emphasizes the need for a histamine positive-control test. Patients who are receiving beta agonists may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis (7.1) Patients should discontinue medications known to suppress the histamine response prior to skin testing including: antihistamines (7.2), tricyclics (7.4), and topical corticosteroids and topical anesthetics (7.3)
Contraindications
4 CONTRAINDICATIONS None. None (4)
Overdosage
10 OVERDOSAGE For all allergenic extracts the therapeutic dose varies per indiviual. If a dose exceeds the window for a particular patient this may be considered an overdose and the patient may experience anaphylaxis. Systemic reactions are uncommon after injection, but if the patient receives more extract than can be tolerated at that particular time, and begins to experience immediate hypersensitivity anaphylaxis, institute emergency treatment by trained personnel. Overdosage may occur because of an error in the volume of extract or incorrect diluents injected. An overdose may also occur when, in addition to immunotherapy, the patient is exposed concomitantly to similar environmental allergens. In the event of a systemic reaction, the preparation of allergen and dosage schedule should be carefully reviewed.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Mite extracts in 50% Glycero-Coca solution are supplied as follows: D. farinae : NDC 22840-0033 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0035 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0036 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. pteronyssinus : NDC 22840-0036 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae / D. pteronyssinus mixture: NDC 22840-0037 5,000 Allergy Units/mL each species, 5 mL percutaneous test vial D. farinae / D. pteronyssinus mixture: NDC 22840-0037 5,000 Allergy Units/mL each species, 10, 30, and 50 mL vials D. farinae : NDC 22840-0038 30,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0039 30,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae / D. pteronyssinus mixture: NDC 22840-0040 15,000 Allergy Units/mL each species, 10, 30, and 50 mL vials 16.2 Storage and Handling 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. Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.