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Standardized Mite D. pteronyssinus 10000 [AU]/mL Solution, 5 mL — NDC 00268-7001-06 package photo

Standardized Mite D. pteronyssinus 10000 [AU]/mL Solution, 5 mL

by ALK-Abello, Inc. · 5 mL in 1 VIAL, MULTI-DOSE (0268-7001-06)
NDC 00268-7001-06
🏷️ FDA NDC (as labeled) 0268-7001-06 billing pads the labeler segment with a zero
Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0268-7001-06
Product NDC 0268-7001
11-digit billing NDC 00268700106
Application # BLA103752
SPL Set ID cbe1d24d-df77-4940-baf8-623993fa731b
Established class (EPC) Antigens; Standardized Insect Allergenic Extract
Physiologic effect Cell-mediated Immunity; Increased Histamine Release; Increased IgG Production
Chemical class Allergens; Dermatophagoides; Insect Proteins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-08-14
Route PERCUTANEOUS
Dosage form SOLUTION
Substance DERMATOPHAGOIDES PTERONYSSINUS
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 0268-7001-06 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00268-7001-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerALK-Abello, Inc.
FDA applicationBLA103752 (BLA)
Labeler code00268
First marketedAug 1990
Product typeStandardized Allergenic
Portfolio411 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Standardized Mite D. pteronyssinus 10000 [AU]/mL 00268-0277-10 ALK-Abello, 10 ml — — FDA listed —
Standardized Mite D. pteronyssinus 10000 [AU]/mLthis 00268-7001-06 ALK-Abello, 5 ml — — FDA listed —
Standardized Mite Dermatophagoides pteronyssinus 10000 [AU]/mL 22840-0036-03 Greer 5 ml — — FDA listed —
House Dust Mite, Dermatophagoides pteronyssinus 10000 [AU]/mL 49643-0704-05 Allermed 5 ml — — FDA listed —
Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL 10000 [AU]/mL 65044-6695-02 Jubilant 10 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
1950
First FDA approval
Sep 1950
📍
2026
Currently FDA-listed
76 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00268-7001-06 You're viewing this 5 mL in 1 VIAL, MULTI-DOSE (0268-7001-06) 1990-08-14 Active

🧭 About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0268-7001-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00268-7001-06, written without dashes as 00268700106. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00268-7001-06, the first segment (00268) is the labeler code FDA assigned to ALK-Abello, Inc.; the middle segment (7001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ALK-Abello, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ALK-Abello, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 Storage and Handling 📋 Description
🚨 Boxed Warning ~2 min read ▾

WARNINGS Standardized allergenic extract is intended for use by physicians who are experienced in the administration of standardized (AU/mL) allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract.

The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from other types of extracts to standardized allergenic extracts should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if reaction symptoms occur.

As with all allergenic extracts, severe systemic reactions may occur. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. In certain individuals, these life-threatening reactions may result in death.

Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, should be immediately available in the event of a life-threatening reaction. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe.

See the warnings , precautions , adverse reactions and over-dosage sections below. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators.

Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously.

Refer to the warnings, precautions and adverse reaction sections below. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Experience Reporting, HFM-210 Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville Maryland 20552-1448.

🎯 Indications and Usage 114 words ▾

INDICATIONS AND USAGE This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species.

Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. When diluting bulk extracts, use of either Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique.

Commonly 10 fold dilutions are used to achieve a desired concentration for intradermal testing or initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 AU/mL extract into 4.5 mL of diluent will yield 5 mL of extract @ 1,000 AU/mL. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.

Care should be exercised to avoid cross contamination of allergens if mixing with other allergenic extracts. The use of separate syringes for each allergen and diluent when compounding patient mixes is recommended. Diagnosis - In diagnosing the sensitive individual, the symptom history must be associated with exposure to the allergen.

Skin testing is used in conjunction with a definitive history for diagnosing individual sensitivities. An excellent method of recording results is to cover the skin reaction with transparent tape, outline the erythema first then the wheal with an indelible pen, then remove the tape and transfer it to the patient's permanent record. For preferred results, it is recommended that the actual measurement of the extent of both responses be recorded.

This can be accomplished by measuring the longest erythema diameter, then selecting the mid - point of that line and measuring at a 90 o angle to that line to determine the orthogonal diameter. The sum of these two measurements is the sum of erythema (∑E); the sum of wheal diameters is determined in a similar manner. Patient's response is graded on the basis of the size of erythema and/or wheal.

Percutaneous (prick/scratch/puncture) test: Prick, scratch, or puncture skin tests should be performed initially using an extract specially made for this purpose. The usual dose is one drop. In a skin test study of 10 patients who were determined to be allergic to mite (D. farinae), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 73 mm (range 43 - 138 mm) and a sum of wheal of 17 mm (range 7 - 31 mm).

In another skin test study of 11 patients who were determined to be allergic to mite (D. pteronyssinus), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 84 mm (range 56 - 112 mm) and a sum of wheal of 20 mm (range 7 - 33 mm). What follows are general guidelines for percutaneous testing. Different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer's or distributor's instructions when grading reactions.

0 No wheal. Erythema absent or very slight (not more than 1 mm in diameter). + Wheal absent or very slight erythema present (not more than 3 mm diameter). ++ Wheal not more than 3 mm diameter, or erythema not more than 5 mm diameter. +++ Wheal between 3 mm and 5 mm in diameter with erythema. Possible pseudopodia and itching. ++++ Any larger reaction with itching and possible pain.

Intradermal test: On the forearm or upper outer aspect of the arm, using a 26 - 27 gauge, short bevel needle, inject intradermally .05 mL of the intradermal test solution. Skin whealing responses should be observed 10 - 20 minutes after administering the test. In a skin test study of the 10 mite puncture reactive patients (D. farinae) described above, the mean intradermal dose for ∑E = 50 mm was

0.01AU/mL ( range = <0.0003 to

0.4AU/mL). In the skin test study of the 11 mite puncture reactive patients (D. pteronyssinus) described above, the mean intradermal dose for ∑E = 50 mm was 0.006 AU/mL ( range = <0.0007…

⛔ Contraindications 161 words ▾

CONTRAINDICATIONS There are no known absolute contraindications to immunotherapy. However, a patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms and positive skin tests. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control.

Also, there is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases. 5,6,7 Hyposensitization should be given cautiously to patients with this predisposition. Patients with severe cardiorespiratory symptoms are at additional risk during a systemic reaction.

The physician must weigh the risk to benefit in these cases. Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction. Also, see BOXED WARNING section.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself.

⚠️ Warnings ~2 min read ▾

WARNINGS See warnings at the beginning of this package insert. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract.

A reduction in starting dose is recommended in the following circumstances: Changing to a new lot of extract from the same manufacturer Using product from a different manufacturer Using non-standardized extract or any other change in formula Changing to a product bearing a later expiration date When a prolonged lapse in time has occurred since the last injection Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions: - Severe rhinitis or asthma symptoms; - Infection or flu accompanied by fever; - Exposure to excessive amounts of clinically relevant allergen prior to therapy.

Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe non-reaction-eliciting level.

When switching one standardized extract with another, at least 75% reduction in dose is suggested. Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstructions, hypotension and coma, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1000) is recommended.

Maximal recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.

Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary.

Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation. DO NOT GIVE INTRAVENOUSLY . Mite Extracts (D. farinae and/or D. pteronyssinus) contain small (<1%) amounts of residual media components (pork and yeast).

The physician should proceed with caution when using mite extract in mite sensitive individuals that also demonstrate sensitivity to these media components and only if clearly warranted. In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with allergenic extract injections.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Local: Reactions at the site of injection may be immediate or delayed. Immediate wheal and erythema reactions are ordinarily of little consequence, but if very large, may be the first manifestation of systemic reaction. If large local reactions occur, the patient should be observed for systemic symptoms for which treatment is outlined below.

However, systemic reactions may occur in the absence of large local reactions. Delayed reactions start several hours after injection with local edema, erythema, itching or pain. They are usually at their peak at 24 hours and usually require no treatment.

Antihistamine drugs may be administered orally. The next therapeutic dose should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions. Systemic: Reports from regulatory authorities in Sweden to the FDA, indicated that several deaths have been associated with the use of mite extracts.

The FDA was subsequently informed that these deaths may have been related to use by physicians untrained in the administration of potent extracts rather than a product defect. It should be noted that anaphylaxis and deaths following the injection of mite and other extracts have also been reported by The British Committee on Safety in Medicine. 9 Fatalities from immunotherapy in the United States since 1945 have been extensively reviewed by Lockey, R F, et al 10 , Reid M J et al.

11 and more recently by Bernstein, D. I. et al 23 . With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms.

Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Systemic reactions are characterized by one or more of the following symptoms: Sneezing, mild to severe general urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, hypotension, syncope and upper airway obstruction. Symptoms may progress to shock and death.

Patients should always be observed for 20 to 30 minutes after any injection. Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm.

Severe airway obstruction, unresponsive to bronchodilator, may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration 0.2 mL to 1.0 mL of Epinephrine Injection (1:1000) is recommended. Maximal recommended dose for children under 2 years of age is 0.3 mL.

Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes. The next therapeutic injection of extract should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions.

🔄 Drug Interactions 145 words ▾

DRUG INTERACTIONS: Drugs can interfere with the performance of skin tests. 8 Antihistamines: Response to mediator (histamine) released by allergens is suppressed by antihistamines. The length of suppression varies and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines.

The duration of this suppression may be as little as 24 hours to several days. Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine which may last for a few weeks. Beta 2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.

Dopamine: Intravenous infusion of dopamine may inhibit skin test responses. Beta Blocking Agents: Propranolol can significantly increase skin test reactivity (See WARNINGS ). Other Drugs: Short acting steroids, inhaled beta 2 agonists, theophylline and cromolyn do not seem to affect skin test response.

🤰 Pregnancy 120 words ▾

PREGNANCY - CATEGORY C: Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Controlled studies of hyposensitization with moderate to high doses of allergenic extracts during conception and all trimesters of pregnancy have failed to demonstrate any risk to the fetus or to the mother.

However, on the basis of histamine's known ability to contract the uterine muscle, the release of significant amounts of histamine from allergen exposure of hyposensitization overdose should be avoided on theoretical grounds. Therefore, allergenic extracts should be used cautiously in a pregnant woman, and only if the benefit outweighs the risk.

🧒 Pediatric Use 40 words ▾

PEDIATRIC USE: Children can receive the same dose as adults, however, to minimize the discomfort associated with dose volume it may be advisable to reduce the volume of the dose by half and administer the injection at two different sites.

🧓 Geriatric Use 22 words ▾

GERIATRIC USE: Studies in geriatric patients have not been conducted. Physicians should consider risk to benefit of immunotherapy in this patient population.

🧬 Clinical Pharmacology 195 words ▾

CLINICAL PHARMACOLOGY Diagnostically (for skin testing) the allergen combines with IgE antibodies fixed to mast cells in the skin. 3 This complexing causes an increase in cellular permeability and degranulation of the mast cells releasing chemical mediators. These mediators (such as histamine) are responsible for a local inflammatory response of wheal and erythema typical of a positive skin test reaction and also, the symptoms commonly associated with allergic disease.

The more mediator release, the larger the reaction (wheal and erythema). Treatment consists of the subcutaneous injection of gradually increasing doses of the allergens to which the patient is allergic. It has been demonstrated that this method of treatment induces an increased tolerance to the allergens responsible for the symptoms on subsequent exposure.

Although the exact relationships between allergen, skin sensitizing antibody (IgE) and the blocking antibody (IgG) have not been precisely established, clinically confirmed immunological studies have adduced evidence of the efficacy of hyposensitization therapy. Numerous controlled studies have demonstrated the clinical efficacy of immunotherapy with cat, dust mites and some pollen extracts. 4 Nevertheless, responses are not uniform but variable, and in a few studies, the majority of the patients reported no appreciable improvement.

📦 Storage and Handling 52 words ▾

STORAGE: To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2 o to 8 o C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

📋 Description ~3 min read ▾

DESCRIPTION Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus), used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork.

The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material. Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination.

Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive. In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract. For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter.

This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing. 1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL). 2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy.

In addition to the total allergen activity as described above, each Lot of Mite Extract @ 10,000 AU/mL is tested for two important specific allergens, Group I and Group II (Der f 1; Der p 1 and Der 2) (12, 13, 14, 15, 16, 17) by sandwich ELISA (18, 19, 20 , 21, 22 ) . Specific Lot values of these allergens are available from ALK-Abelló, Inc. by calling the Scientific Affairs Department. Phone # 866-255-7722 or fax # 888-329-2551 The tables below provide summary data of released lots including coefficient of variation (% CV), range (min and max), and ratios on lots manufactured from 2002 through 2006.

Table 1: Summary data: specific allergen content of 22 lots of Standardized Mite Allergenic Extract. Dermatophagoides farinae 10,000 AU/mL. Der f 1 Der 2 1+2 Ratio 1:2 Average 67 89 156 0.76 % CV 36 27 29 22 Min 21 51 90

0.26 Max 140 141 281

0.99Table 2: Summary data: specific allergen content of 24 lots of Standardized Mite Allergenic Extract. Dermatophagoides pteronyssinus 10,000 AU/mL. Der p 1 Der 2 1+2 Ratio 1:2 Average 67 69 136 0.97 % CV 27 22 23 16 Min 41 45 90

0.70 Max 98 104 184

1.27Table 3: Summary data: specific allergen content of 24 lots of Standardized Mite Allergenic Extract. Each mL contains 5,000 AU/mL D. pteronyssinus and 5,000 AU/mL D. farinae. Der f 1 Der p 1 Der 2 1+2 Ratio 1:2 Average 34 34 79 146 0.87 % CV 31 27 21 19 15 Min 21 21 49 98

0.61 Max 58 46 106 203

1.11Ratio max/min 2.8 2.2 2.1 2.1 1.8

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.